Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis
Phase: NA
Conditions: Insomnia Chronic, Cannabis Use
Sponsor: University of Michigan

 
 
 
 
 
 
 
 
Reducing cannabis use for sleep among adults using 
cannabis 
 
 
 
 
 
NCT03964974    
 
 
IRB Approval Date: August 18, 2020 
 
 
 
 
 
 

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Study Protocol 
v.6 – 7/2020 
 
 
 
 
IRBMED #:  
HUM00151282 
 
Study Title:  CannSleep  
 
Grant Title:  Reducing Cannabis Use for Sleep Among Adults Using Medical Cannabis 
 
 
Multiple-Principal Investigator:  
Mark Ilgen, PhD 
 
Multiple-Principal Investigator:  
J. Todd Arnedt, PhD 
 
 
Co-Investigators:  
 
Kipling Bohnert, PhD 
Deirdre Conroy, PhD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BACKGROUND 
Both the number of users of medical cannabis and the number of states legalizing cannabis for medical 
and recreational purposes are rapidly on the rise.1,2 Research on medical cannabis patients indicates that they 
are primarily lower-income, middle-aged adults, with poor mental health and physical functioning, who use 
cannabis heavily. Recent national survey data, for example, indicate that adults who use medical cannabis are 
more than four times more likely to use cannabis daily compared to only recreational users3 – a pattern of use 
linked to sustained intoxication and significant impairment in cognitive and social functioning.4-9 Innovative 
strategies to improve the health and functioning of this population are critically needed. Our data from 800 
patients seeking medical cannabis indicate that insomnia is a chief comorbidity among medical cannabis users 
and a principal reason for cannabis use, with 80% reporting regularly using cannabis for insomnia.10 We 
hypothesize that addressing insomnia in these individuals with evidence-based strategies will lead to 
improvements in sleep and health-related functioning. 
Cognitive behavioral therapy for insomnia (CBTi) is an evidence-based treatment targeting behavioral and 
cognitive factors critical to chronic insomnia. Multiple controlled trials indicate that 70-80% of patients with 
chronic insomnia (alone or accompanied by other health conditions) benefit from CBT,11-13 as many as 50% 
achieve remission from insomnia,14,15 and treatment benefits are sustained over time.16-19 However, previous 
studies have excluded regular cannabis users; consequently, the benefits of CBTi for improving insomnia, 
functioning, and reducing reliance on cannabis have not been evaluated in these individuals. Our group has 
shown that CBTi improves sleep and functioning in patients with alcohol use disorders (AUD), and that CBTi 
can be successfully administered by telephone to non-AUD patients with chronic insomnia. Telehealth delivery 
is a key modality to expand access to CBTi in the general population and it is likely to have a particularly high 
impact for individuals who are disconnected from standard healthcare settings, such as adults with medical 
cannabis certification. However, adaptation and iterative refinement of this promising treatment via telephone 
delivery is necessary to improve the relevance to non-treatment-seeking individuals who use cannabis for 
insomnia. 
The overall premise for this study is based on a combination of observational and correlational work that 
highlights the high prevalence and robust associations between cannabis use and sleep disturbances 
combined with randomized trials that demonstrate the existing efficacy of CBTi in different patient populations. 
The overarching goal of this proposal is to modify and refine this evidence-based treatment to increase 
relevance for individuals using cannabis for insomnia, to assess the distribution and variability of the primary 
variables of interest, and to measure potential mechanisms of change. These aims would provide all of the 
elements required for a future fully-powered randomized trial of the longer-term efficacy of CBTi-CB among 
those using cannabis. This line of research would be the first to evaluate a highly effective sleep-focused 
intervention and determine the effects on sleep-related and non-sleep-related cannabis use in a non-treatment 
seeking population. 
OBJECTIVES 
The objectives of this project are to adapt and tailor an existing intervention (CBTi) for adults who use cannabis 
to be delivered remotely via video chat or telephone therapy sessions, and to evaluate the acceptability and 
feasibility of this intervention. This study will include (1) tailoring the existing CBTi intervention to the population 
based on qualitative data collected from 10 individuals who use cannabis for insomnia, and (2) beta testing the 
revised CBTi intervention and a developed control condition (Sleep Education Control; SE) in up to 8 
individuals who regularly use cannabis for insomnia. Information regarding the feasibility and acceptability of 
the intervention and study procedures (e.g. wearing a sleep device and completing daily assessments) 
collected during the beta testing phase will be used to inform the procedures utilized during a subsequent pilot 
randomized (RCT) controlled trial of CBTi-CB vs. SE. For the pilot trial, 60 individuals who report using 

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cannabis for insomnia will be recruited from medical cannabis clinics and dispensaries to participate in a pilot 
randomized controlled trial (RCT) of CBTi-CB versus a Sleep Education Control (SE). Our central hypothesis 
for the pilot RCT is that an evidence-based CBTi approach will improve insomnia and health-related 
functioning among those who use cannabis to help with insomnia.  
The specific aims of the study are: 
 
Specific Aim 1: Adapt and iteratively refine an existing CBTi intervention to (1) address the unique needs 
of individuals using cannabis for insomnia, and (2) allow the intervention to be delivered remotely via video 
chat or telephone.).  We will also adapt and refine an attention matched Sleep Education Control (SE) 
condition to be delivered remotely. This aim will be accomplished in two phases. Phase 1 will include 
modifying treatment manuals and conducting qualitative interviews with 10 individuals who use cannabis for 
insomnia to better understand perceptions of the relationships among insomnia, coping, functioning and 
cannabis use, as well as what might influence intervention adherence. In Phase 2, both manuals will be beta-
tested with up to 8 participants (4 for CBTi-CB and 4 for SE). 
 
 
Specific Aim 2: Conduct a pilot RCT comparing CBTi-CB (n=30) to SE (n=30) delivered remotely to (a) 
assess the acceptability and feasibility of RCT procedures; (b) determine the distribution and variability of the 
primary outcomes (insomnia severity, health-related functioning); and (c) assess potential mechanisms of 
change (sleep-related behaviors; sleep-related beliefs; sleep self-efficacy; and cannabis use motivation) within 
the CBTi-CB and SE conditions. 
The proposed project addresses a key objective articulated in the most recent NIDA Strategic Plan, 
specifically, to “develop and test novel treatments based on the science of addiction” (Objective 3.1). This work 
is significant because of the large and growing number of US adults who use cannabis to manage their 
insomnia. Given the extent of daily cannabis use in users of cannabis for insomnia, intervening on sleep in this 
group represents the opportunity to engage and improve outcomes in those with heavy cannabis use. The 
study is innovative because it targets insomnia, a highly comorbid condition in a group of non-treatment 
seeking individuals, and proposes that improvement in sleep will reduce cannabis use and improve health-
related functioning. The impact is enhanced by leveraging telemedicine approaches to optimize reach of the 
treatment. 
 
RESEARCH DESIGN AND METHODS 
Overview of approach. The purpose of this project is to adapt, iteratively refine, and pilot test an existing CBTi 
intervention for use in adults who currently use cannabis for insomnia (CBTi-CB). The proposed work is 
consistent with Stages IA/IB of the NIH Stage Model of Intervention Development.20,21 Also in line with these 
recommendations, the pilot trial will gather data on the extent to which participation in the CBTi-CB intervention 
is associated with changes in the proposed mechanisms of action of the intervention.20,21 The proposed project 
has two primary aims: (1) adapt and iteratively refine remotely-delivered CBTi-CB to address the unique needs 
of individuals using cannabis for insomnia and develop and refine a matched remotely-delivered Sleep 
Education Control (SE) condition; and (2) conduct a pilot randomized controlled trial (RCT) comparing 
remotely-delivered CBTi-CB to SE to (a) assess the feasibility of RCT procedures; (b) determine the 
distribution and variability of the primary outcomes (insomnia severity, health-related functioning); and (c) 
assess potential mechanisms of change. 
 
Overview setting and existing content of CBT for insomnia and SE conditions. 
Study site description. Recruitment for all phases of the proposed study will occur from clinics operated by 
Michigan Holistic Health and Michigan Medical Marijuana Certification Center (two of the largest organizations 

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of medical cannabis clinics in the state of Michigan) or from Michigan licensed marijuana dispensaries. We 
have recruited in both medical clinics for our prior NIDA-funded study and it has been our experience that clinic 
staff were very supportive and patients were interested in participating in research. Recruitment for the beta 
testing and RCT phases of the study will occur from cannabis provisioning centers (also called dispensaries) 
operated by OM of Medicine and Bloom City Club (see letters of support). Dispensaries are generally open 
from 10am to 8pm on weekdays and see approximately 20-70 patients per day. All dispensaries have 
designated waiting rooms in which potentially eligible participants can be approached. All recruitment sites 
understand the nature of our research project and are supportive of us basing our screening and recruitment 
efforts within their dispensaries. 
Structure of CBTi-CB and SE conditions. In order to keep non-specific factors consistent across conditions, 
CBTi-CB and SE will be delivered in a similar format and over the same time interval. Both conditions will 
follow a manual and will be delivered by a masters-level therapist. Both conditions will involve six 45-60-minute 
individual remote therapy sessions - that will be delivered weekly for 6-8 weeks (with a range to be flexible to 
accommodate participant schedules). Patient modules will be developed for both interventions. We opted to 
deliver the intervention over the phone or via video chat to maximize engagement and reach, given our prior 
work indicating that cannabis users are geographically dispersed, responsive to study contacts over the phone, 
and many face barriers to in-person sessions. 
Content and format of CBTi-CB and SE conditions. The CBTi-CB intervention will be derived from CBTi 
manuals previously developed by our team for a study of individuals with chronic insomnia, which was 
telephone delivered, and a prior NIAAA-funded study of CBTi in subjects with AUD delivered face-to-face. The 
content will be revised to focus on cannabis use and sleep and patient materials will be altered to allow remote 
delivery. The overall structure and sleep-oriented content will remain essentially unchanged. The SE 
intervention will be developed using modified versions of matched control conditions from two studies of CBT 
for pain (one funded by VA HSR&D and one funded by NIDA), CBT for suicide risk (a prior NIDA R21 and an 
ongoing DoD study), and a NINR-funded study of CBTi in post-menopausal women. Aim 1 is devoted to 
modifying and iteratively refining the content of these conditions. 
CBTi-CB. Each CBTi-CB therapy session will follow a format standard to CBTi,73 which begins by 
qualitatively reviewing the previous week of sleep/wake diaries and quantitatively summarizing key sleep 
parameters, which are shared with participants. No single session will be focused exclusively on cannabis use. 
Instead, content related to cannabis will be integrated into each session's specific insomnia-related focus. 
Cannabis use is primarily conceptualized as a maladaptive coping response and the treatment will address 
cannabis use by increasing the use of more appropriate coping strategies and improving self-efficacy to 
manage insomnia and next-day consequences without cannabis. The current content of the CBTi protocol 
includes: (1) Sleep Scheduling Strategies: The primary goal of these strategies is to consolidate sleep using 
behavioral strategies that increase the drive for sleep and stabilize the circadian timing system. Specifically, 
sleep restriction curtails the amount of time spent in bed each night to the patient’s estimated average total 
sleep time to increase sleep drive, thereby enhancing sleep onset and maintenance.53 Time in bed is gradually 
increased in subsequent treatment sessions to improve nighttime sleep quality and optimize daytime 
functioning. Stimulus control is designed to associate temporal (bedtime) and environmental (bed, bedroom) 
cues with rapid sleep onset and to establish a regular sleep-wake schedule;73 (2) Sleep Hygiene: Sleep 
Hygiene refers to behaviors, substances, and environmental conditions that can help or hinder sleep. The 
following sleep-positive practices are promoted: regular meals, pre-bedtime routine, regular exercise, limited 
intake of caffeine, alcohol, nicotine, and liquids in the evening, and a good quality sleep environment (quiet, 
dark, and comfortable); (3) Cognitive Therapy: Cognitive therapy in CBTi aims to identify and alter 
dysfunctional beliefs about sleep and functioning that contribute to maintaining insomnia. Patients are first 
educated about common insomnia-related cognitive themes (e.g., perceived consequences of insomnia) and 

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identify individualized sleep-disrupting cognitions and are then taught cognitive strategies to challenge the 
validity of these unhelpful cognitions; (4) Counter-Arousal Strategies: A common characteristic of insomnia is a 
predisposition to ruminative thoughts and increased body tension that interferes with the ability to fall or return 
to sleep.74 This “hyperaroused” state is often present throughout the day and night in patients with insomnia 
and is thought to reflect both trait and state components.75 Brain imaging studies support subjective complaints 
by patients with insomnia, showing elevated brain activity compared to patients without insomnia.76 The goals 
of counter-arousal techniques are to directly address cognitive or somatic hyperarousal through the use of 
behavioral and cognitive techniques, such as deep breathing/relaxation and constructive worry; (5) Relapse 
Prevention for Insomnia: Participants review treatment gains and the individualized behavioral and cognitive 
strategies that were most helpful. Relapse prevention involves identifying high-risk situations for insomnia, 
promoting realistic appraisals about future insomnia episodes, and identifying behavioral and cognitive 
strategies for dealing with the inevitable occasional poor night of sleep.73 
In order to assess for receipt of CBTi-CB content, participants will complete weekly pre-session and post-
session assessments related to the content of each session (treatment comprehension measures). 
Sleep Education (SE). In order to enhance the scientific rigor and minimize bias, the SE condition will be 
matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social 
support from a study therapist, without providing individualized recommendations. Proposed content for the 
remotely -delivered SE control will include: (1) Insomnia History: This session will be devoted to learning about 
the participant’s insomnia history, including triggers that initiated the sleep problem, its duration, severity, and 
frequency, premorbid sleep characteristics, and previous sleep medication and non-medication treatments; (2) 
Sleep Education: This session will provide basic education about why we sleep, sleep stages, how sleep is 
regulated at night, and sleep changes across the lifespan; (3) Substance Use and Sleep: This session will 
focus on the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors and 
Sleep: This session will focus on the general factors that contribute to a sleep-conducive environment; (5) 
Lifestyle Factors affecting Sleep: This session will address the effects of diet, exercise, and napping on sleep. 
Subjects will also be educated about the importance of regularity of activity and meal times to enhance sleep 
quality; (6) Sleep Maintenance Strategies: The final session will focus on reviewing treatment gains from the 
participant’s perspective and emphasizing the principles covered over the previous sessions in order to 
maintain sleep improvements. 
 
Similar to the CBTi-CB condition, SE participants will complete weekly pre-session and post-session 
treatment comprehension assessments. 
 
Specific Aim 1: Adapting and iteratively refining the CBTi-CB and SE conditions. As noted above, the 
initial content of the CBTi-CB and SE exists from previously developed treatment manuals; however, the 
content will need to be modified to fit within a new setting, to be delivered remotely, and to address issues 
specific to adults who use cannabis. Iterative refinement of the content will occur in 2 phases. 
Specific Aim 1 - Phase 1 (Qualitative Interviews). The PIs will draft initial detailed treatment manuals 
and companion patient modules for CBTi-CB and SE. Each of the existing sessions will be re-written to fit with 
delivery over the phone and to emphasize content specific to cannabis. The prior manuals included minimal 
information on cannabis (substance related information focused on alcohol and substances of abuse in 
general). These will be re-written to focus more directly on cannabis and the ambivalence that participants may 
feel about changing cannabis use patterns. 
The other project investigators (Drs. Bohnert and Conroy) will review the initial treatment manuals and 
patient modules for comment and, together with the PIs, will constitute an Internal Advisory Group. The other 
investigators bring different areas of expertise to contribute to the treatment manuals and patient modules. For 

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example, Dr. Bohnert will utilize his expertise in cannabis and factors underlying cannabis use to enhance 
sections related to harm reduction. Dr. Conroy will draw on her specific expertise in sleep and cannabis to 
focus on clear communication of the content related to sleep and cannabis. Based on the feedback of the 
Internal Advisory Group, the PIs will draft a revised version of the treatment protocol. 
The project staff will conduct 10 qualitative interviews with individuals recruited from the study sites with 
subjects who use cannabis for insomnia (men: n=5; women: n=5) to better understand perceptions of the 
relationships among insomnia, coping, functioning and cannabis use, as well as what might influence 
adherence to a 6-session remotely delivered intervention. Screening and recruitment for these qualitative 
interviews will be based in the study sites described above and will mirror the methods used in the prior NIDA 
cohort study as well as the planned methods for the beta testing in Phase 2 (see below) and the pilot RCT to 
be conducted for Aim 2.  
Potential participants will be approached by study staff in the waiting room at the clinic sites and invited to 
participate in the study. Study staff will follow the recruitment script which includes eligibility screening 
questions. No identifying information will be collected from those who are not eligible or choose not to 
participate in the study. Written informed consent will be obtained from all participants. Participants will receive 
$50 for the completing the qualitative interviews. 
These qualitative interviews will allow for feedback on the potential content of initial drafts of the CBTi-CB 
and SE manuals. The study PIs will make revisions to the manuals based on this input and these new manuals 
will be further refined with feedback from the Internal Advisory Group. 
Data Analysis. Qualitative interviews will be conducted with individual participants until thematic saturation 
is reached to offer sufficient insight to help refine the CBTi-CB condition for this study. Interviews will be 
audiotaped and transcribed. A rapid data analysis process will be utilized; this is a qualitative approach used 
when there is need for time-sensitive targeted and actionable qualitative information. Intervention development 
will consist primarily of identifying preferences for content delivery and content via qualitative interviews with 
participants, and thus will not involve formal statistical inference. We may conduct descriptive analyses of 
participants’ data regarding preferences which, combined with feedback from the field testing, will lead to 
refinements in the intervention content and delivery. 
Specific Aim 1 - Phase 2 (Beta testing). Based on participant feedback and internal advisory group 
revisions, both treatment manuals (CBTi-CB and SE) will be beta-tested with 8 participants (4 for CBTi-CB and 
4 for SE). Following the eligibility consent process, participants in the beta testing phase will be asked to 
complete a screening survey and a voluntary urine drug screen to confirm eligibility prior to completing other 
study procedures. Participants will receive $10 in cash or gift cards for completing the survey and drug screen. 
Participants who do not wish to provide a urine drug screen will not be eligible to participate in the beta testing 
portion of the project. The drug screen will test for the presence of cannabis, amphetamines, 
methamphetamines, cocaine, and opioids, as cannabis-only zero exposure urine drug tests are not available, 
but we will not be recording any drugs other than cannabis. Interested participants who test positive for 
cannabis and are eligible based on the screening survey will be consented for the full study. They will be asked 
to complete a baseline health survey and a brief (Timeline Followback, TLFB) interview and will be 
remunerated  $40 in cash or gift card. During the baseline assessment, participants will be given an actigraph 
watch to wear during their participation in the study. Participants will be given instructions on the operation and 
care of the device and will be instructed to wear the watch for at least 7 consecutive days. Participants will then 
be assigned to receive either the CBTi-CB or SE condition, depending on participant gender and date of 
enrollment. Each condition consists of 6 therapy sessions, each 45-60 minutes in length, designed to be 
delivered remotely via video chat or telephone once a week over a period of 6-8 weeks post study enrollment. 
All therapy sessions will be audio recorded. Those participants who do not wish to be audio recorded will not 

8 
 
be eligible to participate. During their participation in the study, participants will be receiving daily e-mails from 
REDCap instructing them to complete a brief survey regarding their sleep. Participants will have 24 hours from 
the time the e-mail is sent to complete the survey via REDCap. Following completion of the therapy sessions, 
participants will be instructed to wear the actigraph watch again for an additional 7 consecutive days before the 
follow-up assessment will be completed. The follow-up assessment will include a self-report survey, TLFB 
interview and a semi-structured post-treatment interview, in which participants will be asked to share their 
impressions of each session (e.g., focused on content, length, personal relevance) and of the overall cohesion 
across therapy sessions. Participants will also be asked for feedback regarding wearing the actigraph as well 
as their impressions of completing the daily surveys. At the following up assessment, participants will also be 
asked to provide a voluntary urine drug screen that will detect only the presence of cannabis. Participants will 
receive  $40 in cash or gift cards for completing the follow-up assessment, and will receive an additional $10 in 
cash or gift cards for completing the voluntary urine drug screen. In addition, participant will receive a $30 in 
cash or gift cards to cover costs related to the use of technology for the therapy (e.g. phone minutes or data 
charges). They will also receive an extra $10 in cash or gift cards if they completed at least of four out of seven 
daily surveys per week during their study participation. These are the surveys that ask about sleep and 
cannabis use and are sent to participants daily via email/REDCap. Total compensation for all study activities, 
including eligibility screening, is $140.  
Relevant revisions will be made to the manuals based on feedback generated from the post-treatment 
follow-up assessment. Following completion of all beta-testing participants, one last meeting will occur 
between the Internal and External Advisory Groups to discuss the near-final versions of the manuals and to 
provide the opportunity for any remaining fine-tuning of session content for both conditions prior to the pilot 
RCT trial. 
Developing training protocols for therapists. During the initial phases of the project, we will also refine our 
therapist training protocols. Therapist training will be led by Dr. Conroy and the project coordinator. Dr. Conroy 
is accredited in Behavioral Sleep Medicine and served as a consultant on the national Veteran’s Administration 
cognitive-behavioral therapy for insomnia training program; thus, she is very experienced in training therapists 
in CBTi. Therapists will be required to review training manuals in CBTi (e.g., Insomnia: A Clinical Guide to 
Assessment and Treatment78, Cognitive-Behavioral Therapy for Insomnia: A Session by Session Guide79) as 
well as the study-specific therapist manuals. Skills training will follow both current CBTi dissemination 
protocols80 as well as past experience by the research team, will include activities such as listening to de-
identified tapes from prior research protocols demonstrating the therapeutic techniques, role playing, being 
directly observed by Dr. Conroy while providing CBTi-CB to mock cases and during beta testing. The therapist 
will also receive training on how to handle potential crisis situations and adverse events. Two masters level 
therapists will be trained to deliver both interventions (CBTi-CB and SE). 
Develop CBTi-CB and SE Integrity and Fidelity measures. With participant permission (>90% in previous 
work), all therapy sessions will be audio recorded to ensure therapist fidelity to the intervention manuals. The 
development of the integrity measures will be based on procedures used in Project MATCH81 and the prior 
experience of our research group. For each session topic, dichotomous items for therapist adherence will be 
generated from session outlines and materials to include specific session topics covered. This will produce 6 
session-specific Adherence Rating Scales for each condition. To produce a Therapist Skill/Competence Scale 
to apply across sessions, Likert items covering general CBTi (e.g., delivery of session rationale in CBTi 
framework, skill teaching, in session CBTi exercises) therapist behaviors will be generated based on Cognitive 
Therapy Rating Scale (CTS). Instructions regarding item intent, examples and scoring guidelines will be 
developed for the Session-Specific Adherence Rating Scales, as well as the Therapist Skill/Competence 
Scale.  
 

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Develop participant process/feedback measures. Participant process/feedback measures will be 
developed. Participants will be asked for their feedback regarding their experiences in the using a semi-
structured post-treatment interview. Participants will be asked to share their impressions of each session (e.g., 
focused on content, length, personal relevance) and of the overall cohesion across therapy sessions. 
Questions regarding the acceptability of all study activities will be asked in addition to suggested changes for 
the future trial. Relevant revisions will be made to the manuals and protocol based on this feedback, and a 
session feedback form will be created to assess the helpfulness and relevance of session topics. 
 
Specific Aim 2: Conduct a pilot RCT comparing remotely -delivered CBTi-CB to remotely -delivered 
SE. The second aim of the study is to conduct a pilot randomized trial of CBTi-CB vs. SE (N = 60). This 
approach is pragmatic and real-world in nature, as both conditions will be delivered remotely to individuals who 
report using cannabis for insomnia, yet suffer at least mild insomnia. Participants for the RCT phase will be 
recruited in various ways, including from two Michigan licensed cannabis provisioning centers (OM of Medicine 
and Bloom City Club), online at UMHealthResearch.org, in the community via flyers, on social media, and at 
community events. Participants will be randomized to CBTi-CB or SE and undergo self-reported assessments 
of sleep/insomnia, substance use, and functioning before and after treatment (~8 weeks) and at 16-week 
follow-up. As many subjects as possible will also undergo objective sleep assessment with actigraphy, if 
feasible. The ultimate goal is to use this pilot study to provide all of the necessary elements to conduct a future 
fully-powered RCT comparing these two conditions. To ensure the rigorous conduct of this study, we will utilize 
the CONSORT checklist and flow diagram to document participant accrual, flow and retention at all stages of 
the study.  
A scale will be developed that includes items assessing non-therapeutic or “contaminating” therapist 
behaviors (e.g., use of confrontational strategies, blaming); this scale will be a component of the measurement 
of therapist skill/competence for CBTi-CB and will be the primary measure of therapist skill/competence for SE. 
Twenty-five percent of session tapes will be double-coded using the Adherence and Competence scales. We 
have used similar procedures in prior intervention studies, which have resulted in instruments with sound 
psychometric properties. 
 
Data Analysis. Data will be examined using standard univariate summary measures and bivariate statistical 
measures of association, as well as graphical displays. Tests for linearity, independence, missingness, and 
distributional assumptions (e.g., normality) will be conducted on key variables for each assessment. 
Distributions will be examined to guide modeling decisions. 
Consistent with Stage 1B research, the primary goals for the pilot RCT are to obtain information about 
the feasibility of the proposed RCT and estimate the distribution and variability of primary and potential 
mechanistic outcomes within intervention and control conditions. Initial analyses will involve calculating the 
attrition rates for 6- and 18-week follow-up assessments in each study group and identifying predictors of drop-
out. We will also quantify session attendance and note the percent of participants who did not complete all 
sessions to identify ways to decrease drop-out and non-compliance to the intervention. Additionally, we will 
examine all participant feedback from the Session Feedback Forms and descriptive data from the measures of 
treatment integrity and therapist fidelity measures. To examine treatment integrity and fidelity (the Session-
Specific Adherence Rating Scales and the Therapist Skill/Competence scale), inter-rater reliability will be 
examined with Yule’s Y statistic, by contrasting therapist results with those of the raters, as well as by 
contrasting those of the two independent raters. The items will be summed to produce overall competency 
summary scales. Cronbach’s alpha will be used to examine the internal consistency of each summary scale 
separately for the therapist and raters. The items and rating scales (anchors) will be further refined (added, 
eliminated or modified), if necessary, based on discussion of face validity and analysis of item appropriateness. 
These items will be used to monitor therapist skill and fidelity to the intervention protocol and to maintain the 
integrity of the intervention. 

10 
 
The primary outcomes of interest include insomnia severity, functioning, and frequency of cannabis 
use. Potential mechanisms of the intervention include sleep-related behaviors (e.g., changes in time in bed, 
regularity of sleep schedules) and sleep-related cognitive factors (e.g., changes in sleep-related beliefs, self-
efficacy to manage sleep without cannabis, motivation to use cannabis to manage sleep). Based on recent 
guidelines for Stage 1B research, we will calculate means and standard deviations for primary and mechanistic 
measures at baseline, post-treatment, and follow-up, as well as change scores for the CBTi-CB and SE 
groups. In line with recent recommendations for analysis of data from pilot studies, we will focus on estimation 
of confidence intervals for between-group differences at baseline and all follow-ups.  
Moreover, although we recognize that the proposed project will not have adequate power to serve as a 
definitive study of intervention effects, to prepare for analyses for the future large-scale definitive trial we will 
compare the outcomes between the two study groups. We hypothesize that intervention participants will have 
less severe insomnia, better functioning, and lower frequency of cannabis use at follow-ups. The primary 
outcomes are hypothesized to meet the assumptions of continuous variables, and we will consequently use t-
tests to make comparisons. If, however, the distribution of a measure is skewed, alternative modeling 
strategies (e.g., Poisson regression) will be used. We will examine separate models by sex (i.e., stratified 
analyses). We will also conduct exploratory analyses of how potential mediators (e.g., self-efficacy) relate to 
changes in insomnia and cannabis use, and will examine whether changes in insomnia and cannabis use are 
correlated. Although our sample size is not sufficient to conduct formal mediation analysis, results will inform 
the identification of those variables that best capture the mechanisms for intervention effects. We will use an 
intent-to-treat framework. 
 
 
HUMAN SUBJECTS CONSIDERATIONS 
 
For all phases of this study, approval will be obtained from the Institutional Review Board at the University of 
Michigan. This research is also covered by a Certificate of Confidentiality from NIDA.  
 
Specific Aim 1-Phase 1: Qualitative Interviews 
Recruitment Procedures. Individuals who report cannabis use for insomnia, and suffer at least mild insomnia 
will be recruited from medical marijuana certification clinics and Michigan licensed marijuana dispensaries.  
Clinics and dispensaries are generally open during regular business hours and have designated waiting rooms 
in which individuals can be approached. Individuals ≥21 years of age will be approached by research staff in 
the waiting room at the clinic sites and recruited for the qualitative interview portion of the study. All potentially 
eligible individuals in the waiting rooms of the study sites on days of active recruitment will be invited to learn 
about the study and participate in eligibility screening. Research staff will follow the recruitment script which 
includes questions to determine eligibility. Written informed consent will be obtained from those who are 
eligible and agree to be interviewed.  
 
The project staff will conduct 10 qualitative interviews with participants recruited from the study sites who 
use cannabis for insomnia (men: n=5; women: n=5) to better understand these individuals’ perceptions of the 
relationships among insomnia, coping, functioning and cannabis use as well as what might influence 
adherence to a 6-session telehealth intervention. These qualitative interviews will allow for feedback on the 
potential content of initial drafts of the CBT for insomnia for adults who use cannabis (CBTi-CB) and Sleep 
Education Control (SE) manuals. Participants will be remunerated $50 for participation in the qualitative 
interviews, which will be audio-recorded (with permission) and may take place in person or over the phone  
 
Informed consent. We request a waiver of informed consent to ask eligibility screening questions to potential 
participants as part of the recruitment process. No names or identifying information will be collected from 
individuals who are not eligible or choose not to participate in the study. Written informed consent will be 
obtained from eligible and interested participants. All participants will be told that participation is voluntary, that 

11 
 
they can withdraw at any time, and that this will not impact any aspect of the treatment they receive at the 
clinics or dispensaries. The limits of the Certificate of Confidentiality are explained in the consent form but 
study staff will also verbally explain the limits of confidentiality. The qualitative interviews will commence after 
the participants provide written informed consent. When providing written informed consent, participants will be 
given a copy of the consent form to keep. 
 
Study Eligibility Criteria 
 
The inclusion criteria are: (1) age > 21; (2) Insomnia Severity Index (ISI) score >10, indicative of at 
least “mild” insomnia; (3) use of cannabis once a week during the past 3-months; (4) self-reported use of 
cannabis to manage insomnia at least once in the past week.  
 
The exclusion criteria are: (1) individuals who do not understand English; (2) individuals judged 
unable to provide informed consent (e.g., intoxication, mental incompetence); (3) self-reported cancer; and (4) 
self-reported pregnancy.  
 
Justification for selection criteria. Participants in this study will be 21 years old and older for several 
reasons. First, although state law does allow individuals under the age of 18 to obtain cannabis for medical 
purposes with consent of a legal guardian, available data indicate that very few adolescents have been issued 
medical cannabis cards in Michigan. In addition, with the new recreational marijuana laws allowing non-
medical use of cannabis, we are not solely recruiting medical cannabis users. This new law states all 
recreational marijuana uses must be 21 years or older to possess or use marijuana. Therefore, all participants 
should be age 21 years or older to follow Michigan recreational marijuana laws. 
In order to collect interview data from a sample that will be representative of the population to be recruited 
for the beta testing and RCT, we will exclude those with self-reported cancer or pregnancy. Individuals who 
use marijuana for cancer may experience a different trajectory than those who are not and women who self-
report that they are pregnant will be excluded because: (a) of the potential risks of study participation to 
pregnant women; and (b) we are unlikely to have sufficient numbers of pregnant women to facilitate 
meaningful subgroup analyses. 
 
Potential Risks, Minimizing Risks, and Potential Benefits 
1. Potential Risks 
 
a. Loss of Confidentiality 
 
The major potential risk to study participants is violation of confidentiality of interview data. The risk of violation 
of confidentiality exists because participants will be disclosing personal information in interviews. This risk is 
related to the damage that could be caused by an inadvertent release of sensitive information (e.g., substance 
use, medical conditions). Participants will be informed of the procedures taken to protect their confidentiality.  
 
b. Discomfort During Interview 
There is also a slight risk of psychological discomfort to study participants as a result of being asked personal 
questions on sensitive topics. Participants may also become anxious or upset during discussions of their 
thoughts about managing their insomnia or substance use during the interview.  
2. Minimizing risk 
a) Loss of confidentiality (risk unlikely) To minimize the violation of confidentiality, we will ensure that data are 
protected and cannot be linked to a particular person. Unique identification numbers will be assigned to each 

12 
 
participant and all forms are coded with this number, rather than by name. All data are stored in locked file 
cabinets. Consent forms and subject code/name sheets will be stored separately, because they contain 
identifying information. Data entry staff will work with forms that contain only subject numbers.  Physical 
security of data will be assured by daily and weekly back-ups. For each stage of the proposed research 
investigation, participants’ names and contact information will be stored in a secure, password-protected 
database, separate from their study data and only accessible to members of the research team for research 
purposes. Paper copies of signed consents and completed contact information forms will be stored in locked 
file cabinets only accessible to study staff, separate from study data. Names will be linked to individual ID 
numbers only in a study crosswalk database, which will be kept in a restricted access folder on a secure server 
and destroyed at study completion. Finally, when making telephone calls to contact subjects, we will contact 
only the subject and those people for whom the subject has provided written authorization.  
Data will be collected only with written informed consent from the participant. With participant permission, 
qualitative interviews will be audio-recorded for transcription and analysis, and may take place in person or 
over the phone. The audio-recordings of the interviews will be destroyed after the files are uploaded to a 
password-protected, secure server with restricted access. Participants will be asked not to mention names or 
other identifying information in during the recorded interview. Any identifying information will be removed from 
transcriptions. Once collected, participant data will remain confidential. Only study team members who have 
completed appropriate training in the protection of human subjects at the University of Michigan will have 
access to the data. Hard copies of data will be stored in a locked data storage room in the North Campus 
Research Complex at the University of Michigan. Electronic data will be stored on a secure computer on 
password-protected files and coded by subject identification number so that participants cannot be identified by 
their research record. Any data collected via pen and paper, such as tracking forms, will be manually entered 
using double entry when possible. Data cleaning will be conducted throughout the data collection period to 
ensure the production of a final dataset for analysis at the end of data collection.  
b) Discomfort during assessments (risk likely): 
Participants may become upset, anxious, or uncomfortable as a result of being asked very personal 
questions. To minimize this risk, all interviews will be conducted in private offices with skilled research staff. 
Research assistants will be trained to respond to this emotional distress and to refer participants to appropriate 
resources as necessary. Specifically, this training will include information regarding evaluating warning signs of 
distress that could occur as a result of the screening, intervention, or assessments, and means of addressing 
such issues and minimizing distress. Such strategies will include maintaining an empathic response, 
acknowledging the distress through reflection, avoiding blame, processing in a non-blaming non-
confrontational manner, and eliciting or encouraging use of relaxation and cognitive calming strategies. Crisis 
procedures, effective in previous projects conducted by the study investigators, will also be utilized, including 
immediately paging Drs. Ilgen or Arnedt (Multiple PIs) for consultation. If any research staff observes any 
indication of potential distress, including through review of responses to the assessments, further evaluation of 
the participant will be conducted by a licensed clinician.  All participants are free to terminate the interview at 
any time or refuse to respond to any question. As with any research project, unexpected events are always 
possible. If risk is determined to be present, we will implement our standard clinical protocol for responding to 
suicide risk. Ongoing follow-up will occur until it is determined that risk is minimal.  
3. Potential Benefits of the Proposed Research to Human Subjects and Others 
 
Subjects who participate in this qualitative interview phase of the proposal may experience the benefits of 
catharsis, self-acknowledgment, and self-awareness when disclosing personal information related to their 
experiences of chronic insomnia and of seeking cannabis for the treatment of chronic insomnia. Study staff 
conducting the qualitative interviews will be trained to be empathic and reflect back what they have heard from 

13 
 
participants. This could have benefits that are similar to an unstructured supportive psychotherapy session. 
Participants may also benefit from the knowledge that they are contributing to the development of a treatment 
for a condition that is highly comorbid with the use of cannabis. 
4. Importance of the Knowledge to be Gained 
The risks to subjects associated with participating are reasonable compared to the potential knowledge to 
be gained.  Identifying an effective and safe non-medication treatment for insomnia, a highly common co-
occurring condition in this population of individuals seeking cannabis, could improve nighttime and daytime 
symptoms and reduce cannabis use. The application takes a pragmatic approach to cannabis use to 
investigate whether this approach can help adults who use cannabis to function better and use less cannabis. 
Specific Aim 1-Phase 2: Beta Testing 
Recruitment Procedures. Participants for the beta testing phase will be recruited from two Michigan licensed 
cannabis provisioning centers (OM of Medicine and Bloom City Club). These cannabis provisioning centers 
(also known as dispensaries) are generally open during regular business hours have waiting areas in which 
individuals can be approached. All potentially eligible individuals in the waiting rooms of the study sites on days 
of active recruitment will be invited to learn about the study and participate in eligibility screening. Research 
staff will follow the recruitment script. Written informed consent will be obtained from those who are interested 
and agree to participate. After collecting the informed consent, the eligibility screening survey will be 
administered. Since recruitment will occur in a waiting room of the dispensary, participants will be asked to 
complete the eligibility questions via a brief tablet screen (or paper version if the participant desires) to ensure 
their answers will be kept private. If participants screen eligible via the survey, they will be asked to take a 
urine drug screen to detect THC. If a participant declines to provide a urine sample, or if the results of the urine 
drug screen are negative for the presence of THC, they will be excluded from participating further. Participants 
will be given a small bag containing the test kit to take into a restroom at the recruitment site. For participants 
who are unable or unwilling to provide a urine sample at the recruitment site, they may be given the option to 
complete the urine screen at a separate location (e.g. in the community or at the research office) or at their 
homes. The urine drug screen will provide information regarding recent use for opioids, cannabis, 
amphetamines, methamphetamines, and cocaine, but only cannabis use will be recorded.  
Those who are not eligible will be thanked for their time. Individuals who meet eligibility (individuals who report 
cannabis use for insomnia, suffer clinically significant insomnia, and have a positive urine drug screen for THC) 
based on their answers and urine drug screen will be invited to participate in the full study. Participants will be 
paid $10 cash or gift card for completing the eligibility survey. 
Eligible participants will be invited to participate in the full study, involving a separate consent form. 
Following the completion of the written informed consent for the full study, participants will be asked to 
complete the baseline assessment. Baseline assessments will include both a tablet-based survey (or 
paper/pencil version based on participant preference) and a researcher administered TLFB interview. These 
assessments will gather detailed evidence of problems related to sleep, frequency of recent substance use 
including cannabis use, substance use consequences, depression and self-efficacy. Because we will need to 
contact participants for completion of the daily surveys, therapy sessions, and follow-up assessments, the 
research staff member will collect detailed locator information. This information will include the participant’s 
phone number(s), address(es), e-mail addresses, and contact information for family members/friends who 
would know how to reach them. Participants will also be able to contact study staff or correspond/receive 
appointment reminders through text.  Because participants will complete several assessments remotely, we 
will set up a secure study e-mail account to be used for participants to contact study staff or for study staff to 
send appointment reminders and surveys to participants. The e-mail address is: UM-
CannSleep@med.umich.edu.  

14 
 
Following the administration of study measures, the participants will be provided with an actigraphsleep 
monitoring watch The actigraph (Actiwatch Spectrum Plus, Philips Respironics, Murrysville, PA) is a small 
waterproof device the size of wrist watch (48 mm x 37 mm x 15 mm weighing 31 grams) that is meant to be 
worn continuously on the non-dominant wrist. An accelerometer integrates movement frequency and intensity 
into a single measurement. In addition, a photodiode sensor continuously monitors incoming light and stores 
the data in lux levels. The actigraphs are set at a sampling rate of 30 seconds. Activity and light data are 
downloaded to computer and sleep/wake activity is estimated using Actiware® – Sleep software and following 
published guidelines. Data is accessed through the Actiware® – Sleep software and is identified by study 
participation ID. Participants will be asked to wear the actigraphy activity tracker for one-week (at least 7 
consecutive days) post-enrollment and again for at least one-week post-treatment (at approximately 6 weeks 
post-enrollment). Watches will be returned to the study team after the first 7 days of wear, returned to the 
participant after the last therapy session, and collected by the study team at the follow up assessment. To do 
so, we will ask participants to either 1. send the actigraphy activity tracker back in the mail using a prepaid 
envelope, 2. leave it in a drop box located at the recruitment sites, or 3. have study staff meet the participant at 
home or in the community to pick up or drop off the actigraphy activity tracker. Participants will be asked to 
wear the watch for at least 7 days post-treatment and will return the watch at their in-person follow up or via 
mail after their electronic/mailed follow up is completed. Actigraphy activity trackers will come with 
informational brochures from the Philips Respironics company and pre-paid return envelopes for the 
participants to mail them back after both baseline and post-treatment assessment time points. Once the 
participant completes the survey, research staff will review the survey prior to the participant leaving the room 
to assess for risk status.  
Follow-up assessments will be conducted in person in the community or in our offices at the University of 
Michigan, or via emails containing REDCap survey links or mailed paper surveys where participants can 
complete surveys on their own. For those assessments that occur in the community, research staff will arrange 
to meet participants at a convenient and confidential location in the community (e.g., a local library, their 
home). If we interview a participant in his/her home, we will arrange for a second research staff member to go 
along for staff safety reasons. We have used this process successfully in our prior work with adults with SUD.  
Data Collection: Assessment content will measure demographic characteristics, reasons for seeking 
cannabis and current uses (must include insomnia), frequency and severity of insomnia, and presence of co-
occurring exclusionary medical/psychiatric conditions, and other sleep disorders. The screening assessment 
will include questions that will allow for determination of eligibility.  Baseline assessments are intended to 
confirm eligibility and assess the acceptability of the measures used that will obtain greater detail about sleep, 
functioning, substance use and the proposed mechanisms of change in our theoretical model in our next 
phase. Data will be collected via emailed surveys, tablets, paper, actigraphy, and urine drug screens.  
Specimens: In this study, we will be collecting urine to analyze for recent cannabis use. We will be using 
urine testing kits that give immediate results; therefore, the study staff will be conducting the sample testing 
and no labeling or storage will be necessary. Participants will be given a small bag containing the test kit to 
take into a restroom, either at the recruitment/follow up site or at home. Once the specimen has been provided 
in the test cup, the participant will either return the bag to the research staff member for immediate testing or 
send a picture of the results to the secure study email, if they prefer to take the drug screen at home. Research 
staff will record test results. After testing is complete, the urine sample will be discarded by flushing it down the 
toilet if done in person. No identifying information will be marked on the testing container. The validity of self-
report of cannabis use may be increased when a urine drug screen is performed. The urine drug screen will 
provide information regarding recent use for THC only, for eligibility confirmation. Specimens will be collected 
in a specimen container about 4 oz. in size, although only a minimal amount of urine is needed.  
Assessment 
Instruments 
Screening/ 
Eligibility 
Baseline 
Before 
and/or 
Post-
Intervention 
(~6 weeks) 
Follow 
Up 

15 
 
after 
session 
Demographics 
X 
 
 
 
 
Alcohol, Smoking and 
Substance 
Involvement Screening 
Test (ASSIST) 
X 
 
 
 
 
Fagerstrom Test (for 
nicotine dependence) 
X 
 
 
 
 
Fagerstrom Test (for 
cannabis dependence) 
X 
 
 
 
 
Cannabis Use Disorder 
Identification Test 
(CUDIT) 
X 
 
 
 
 
Perceived Relief (PR) 
X 
 
 
 
X 
STOP-BANG 
(Obstructive Sleep 
Apnea measure) 
X 
 
 
 
 
Restless Leg Syndrome 
Questionnaire (RLSQ) 
X 
 
 
 
 
Insomnia Severity 
Index (ISI) 
X 
 
 
 
X 
Urine Drug Screen 
(THC only) 
X 
 
 
 
X 
Generalized Anxiety 
Disorder 7 Item (GAD-
7) 
 
X 
 
 
 
Personal Health 
Questionnaire 
Depression Scale 
(PHQ-8) 
 
X 
 
 
 
The Revised Behavior 
and Symptom 
Identification Scale 
(BASIS-R) 
 
X 
 
 
 
12-Item Short Form 
Health Survey (SF-12) 
 
X 
 
 
X 
Timeline Follow Back 
 
X 
 
 
X 
Modified Self Efficacy 
Scale (SES) 
 
X 
 
 
X 
Dysfunctional Beliefs 
About Sleep (DBAS-16) 
 
X 
 
 
X 
Substance Use Sleep 
Scale (SUSS) 
 
X 
 
 
X 
Modified Marijuana 
Motives Questionnaire 
(MMQ) 
 
X 
 
 
 

16 
 
Medical Marijuana Use 
 
X 
 
 
 
Prescription Misuse 
(BOYD) 
 
X 
 
 
X 
Cannabis Expectancy 
Questionnaire (CEQ) 
 
X 
 
 
X 
Side Effect Checklist 
(SECL) 
 
X 
 
 
X 
Marijuana withdrawal 
checklist revised 
(MWC-R) 
 
X 
 
 
X 
PEG Three-item Scale 
Assessing Pain 
Intensity and 
Interference 
 
X 
 
 
X 
BRFSS Model 
16(Marijuana Use 
Type) 
 
X 
 
 
X 
Multidimensional 
Fatigue Inventory 
(MFI-20) 
 
X 
 
 
X 
Epworth Sleepiness 
Scale 
 
X 
 
 
X 
Therapy Evaluation 
Questionnaire 
 
X 
 
 
X 
Daily Sleep/Wake 
Diary 
 
X 
X 
X 
X 
Actigraphy 
 
X 
 
X 
X 
Session Attendance 
 
 
X 
X 
 
 
Primary outcomes: These assessments will not be used to assess outcomes but rather to test feasibility 
and acceptability. With participant permission, qualitative interviews, therapy sessions and the follow-up 
interview will be audio-recorded to ensure therapist fidelity to the intervention and for transcription of the 
interviews. Using a semi-structured post-treatment interview guide, participants will be asked to share their 
impressions of each session (e.g., focused on content, length, personal relevance) and of the overall cohesion 
across therapy sessions. We will also be asking about acceptability for participation in all study activities, and 
for any suggested changes for the future trial. Relevant revisions will be made to the manuals and protocol 
based on this feedback. 
All remuneration for the study will be in the form of gift cards or cash. Participants will be remunerated with 
a $40 for the completion of baseline assessment, $40 for completion of the follow-up assessment, $10 for 
completing four out of seven days of the daily online survey for every week enrolled in the study, plus an 
additional $10 incentive for a urine drug screen at follow up. Participants will also receive $30 to compensate 
them for any potential charges related to the use of their technology. Participants who do not complete all 
therapy sessions will still receive the $30 to cover technology costs, however, they must have completed at 
least one phone session.  
 

17 
 
Informed consent. Trained research staff will conduct the informed consent process. This phase of the study 
will have a 2-part consent process. First, an eligibility consent will be completed in order for participants to 
complete the screening survey and urine screen. Second, those who are eligible and interested will complete a 
second consent document explaining the full study. Individuals interested in participating in the study will 
review the consent with the research staff. All participants will be told that participation is voluntary, that they 
can withdraw at any time, and that this will not impact any aspect of the services they receive at the clinics or 
dispensaries, including their ability to receive cannabis. After reviewing the consent form, research staff will ask 
the patient if he/she has any questions regarding their participation or the study requirements and limitations. 
The limits of the Certificate of Confidentiality are explained in the consent form, but study staff will also verbally 
explain the limits of confidentiality. Any patients who request more time to review the consent form or consult 
with others will have the opportunity to do so. These patients will have the opportunity to have research staff 
contact them at a later time or to contact research staff themselves. Those interested in participating will be 
asked to sign the consent form. When providing written informed consent, participants will be given a copy of 
the consent form to keep and the original will be filed in a confidential research file. Study staff will review the 
consent form for accuracy and completeness before beginning any study procedures.  
 
Study Eligibility Criteria. 
Inclusion criteria. (1)  age > 21 or older; (2) Insomnia Severity Index (ISI) score >10, indicative of at least 
“mild” insomnia; (3) use of cannabis three times a week within the past three months; (4) self-reported use of 
cannabis to manage insomnia at least once a week over the past month; (5) consistent access to a telephone, 
smartphone, laptop, or tablet; and (6) a positive urine drug screen for THC. 
 
Exclusion criteria. (1) individuals who do not understand English; (2) individuals judged unable to provide 
informed consent (e.g., intoxication, mental incompetence); (3) diagnosis or high suspicion of a sleep disorder 
other than insomnia based on validated self-report measures; (4) self-reported cancer; (5) self-reported 
pregnancy; and (6) self-reported rotating or night (3rd) shift work. Participants will not be excluded if they are 
taking prescription or over the counter medications for sleep, however they will need to report being stable on 
the medications for at least 8 weeks and agree to maintain the same regime throughout the study. Those who 
have been taking prescription medications for sleep for less than 8 weeks, or who report they are unable to 
continue with their medications for the duration of the study (approximately 10 weeks) will be excluded.   
 
Justification for selection criteria. Participants in this study will be 21 years old and older for several 
reasons. First, although state law does allow individuals under the age of 18 to obtain cannabis for medical 
purposes with consent of a legal guardian, available data indicate that very few adolescents have been issued 
medical cannabis cards in Michigan. In addition, with the new recreational marijuana laws allowing non-
medical use of cannabis, we are not solely recruiting medical cannabis users. This new law states all 
recreational marijuana uses must be 21 years or older to possess or use marijuana. Therefore, all participants 
should be age 21 years or older to follow Michigan recreational marijuana laws. 
In order to collect interview data from a sample that will be representative of the population to be recruited 
for the RCT, we will exclude those with self-reported cancer or pregnancy. Individuals who use marijuana for 
cancer may experience a different trajectory than those who are not and women who self-report that they are 
pregnant will be excluded because: (a) of the potential risks of study participation to pregnant women; and (b) 
we are unlikely to have sufficient numbers of pregnant women to facilitate meaningful subgroup analyses. 
Access to a smartphone, computer, or tablet is required to deliver intervention sessions, as all sessions are 
meant to be delivered remotely via BlueJeans video chat or telephone. Those who do not report having 
reasonable access to the technology needed for the study will be excluded.  
 
Potential Risks, Minimizing Risks, and Potential Benefits 

18 
 
1. Potential Risks 
a.  Loss of Confidentiality 
 
The major potential risk to study participants is violation of confidentiality of survey and interview data. The risk 
of violation of confidentiality exists because participants will be disclosing personal information in surveys and 
interviews. This risk is related to the damage that could be caused by an inadvertent release of sensitive 
information (e.g., substance use, medical conditions). Participants will be informed of the procedures taken to 
protect their confidentiality.  
 
 
b. Discomfort During Interview 
There is also a slight risk of psychological discomfort to study participants as a result of being asked personal 
questions on sensitive topics. Participants may also become anxious or upset during discussions of their 
thoughts about managing their insomnia or substance use during the interview.  
2. Minimizing risk 
a. Loss of confidentiality (risk unlikely)  
To minimize the violation of confidentiality, we will ensure that data are protected and cannot be linked to a 
particular person. Unique identification numbers will be assigned to each participant and all forms are coded 
with this number, rather than by name. All data are stored in locked file cabinets. Consent forms and subject 
code/name sheets will be stored separately, because they contain identifying information. Data entry staff will 
work with forms that contain only subject numbers.  Physical security of data will be assured by daily and 
weekly back-ups. Data cleaning will be conducted throughout the data collection period to ensure the 
production of a final dataset for analysis at the end of data collection.  
 
Study data will be collected and managed using REDCap (Research Electronic Data Capture). Participants’ 
names and contact information will be stored in a secure, REDCap database, separate from their study data 
and only accessible to members of the research team for research purposes. REDCap is a secure web 
application designed to support data capture for research studies. It provides userfriendly web-based case 
report forms, real-time data entry with branching logic and validation (e.g. for data types and range checks), 
audit trails, a de-identified data export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-
Plus), procedures for importing data from external sources, and advanced features such as a data quality 
check module. The system was developed by a multiinstitutional consortium initiated at Vanderbilt University. 
REDCap servers are physically located in the University of Michigan Medical School Information Systems 
(MSIS) data center. Application and database servers are on virtual machines (VM). The VM servers are Red 
Hat Enterprise Linux Server 5.6 (64-bit, 2.6.18 238 e15-smp kernel) 2x AMD Opteron 6174 5.0.95 2.2 GHz 
with 4 GB RAM, running Apache 2.2.3 (application servers) and MySQL (database servers). Physical security 
for the databases is provided in a professionally managed and equipped tier-2 data center with tightly 
controlled access. Remote data access employs SSL encryption and 2-tier Kerberos/Level 1 and UMHS Level 
2 password challenges via LDAP authentication. Access to the application, the database, and the underlying 
systems infrastructure are consistent with industry best practices including HIPAA security and privacy 
requirements and the HITECH Act. The application provides audit trails on user access to MICHR and MSIS 
technical and support teams. Backup of data is managed by MSIS and vulnerability testing is performed 
regularly by the University of Michigan Health 
System Medical Center Information Technology. Risk evaluation is performed using a methodology 
derived from NIST Special Publication 800-53 – “Recommended Security Controls for Federal Information 
Systems” and is used to refine and improve operating policies and procedures. Daily backups and VM 
snapshots of the application and database servers are stored on a remote storage device. The restoration of 
the servers from a hardware or software failure are protected for 24 hours of disaster recovery.  
 
Interviews will be audio-recorded for transcription and analysis, and may take place in person, via an online 

19 
 
video chat (BlueJeans), or over the phone. The intervention sessions will be remotely delivered via telephone 
or BlueJeans video conferencing (https://www.bluejeans.com/). BlueJeans provides a cloud-based 
audio/video/content-sharing conferencing service. The service is vendor-agnostic and allows up to 150 
endpoints to connect for a meeting. U-M's current contract with BlueJeans enables all U-M faculty, staff, and 
students to register for a BlueJeans User Account. BlueJeans collects and maintains data related to the date, 
time, and attendees of a meeting. Actual video or audio content is only stored by BlueJeans when the meeting 
host turns on the recording feature. We will not be using the recording feature on Bluejeans. U-M's agreement 
with BlueJeans includes a Business Associate Agreement. This means individuals may use this service to 
share Protected Health Information (PHI) regulated by HIPAA. For more information, BlueJeans Security and 
Privacy agreements with the University of Michigan can be found at 
https://safecomputing.umich.edu/dataguide/?q=node/181. The audio recordings for the interviews will be done 
with a digital voice recorder. The audio-recordings of the interviews will be destroyed after the files are 
uploaded to a password-protected, secure server with restricted access. Participants will be asked not to 
mention names or other identifying information in during the recorded interview. Any identifying information will 
be removed from transcriptions.  
 
We have set up an email account to be used for subjects to contact study staff or for study staff to send 
appointment reminders and online surveys (via REDCap) to subjects. The e-mail address is: UM-
CannSleep@med.umich.edu. 
b) Discomfort during assessments (risk likely): 
Participants may become upset, anxious, or uncomfortable as a result of being asked very personal 
questions. To minimize this risk, all interviews will be conducted in private offices with skilled research staff. 
Research assistants will be trained to respond to this emotional distress and to refer participants to appropriate 
resources as necessary. Specifically, this training will include information regarding evaluating warning signs of 
distress that could occur as a result of the screening, intervention, or assessments, and means of addressing 
such issues and minimizing distress. Such strategies will include maintaining an empathic response, 
acknowledging the distress through reflection, avoiding blame, processing in a non-blaming non-
confrontational manner, and eliciting or encouraging use of relaxation and cognitive calming strategies. Crisis 
procedures, effective in previous projects conducted by the study investigators, will also be utilized, including 
immediately paging Drs. Ilgen or Arnedt (Multiple PIs) for consultation. If any research staff observes any 
indication of potential distress, including through review of responses to the assessments, further evaluation of 
the participant will be conducted by a licensed clinician.  All participants are free to terminate the interview at 
any time or refuse to respond to any question. As with any research project, unexpected events are always 
possible. If risk is determined to be present, we will implement our standard clinical protocol for responding to 
suicide risk, including giving participants a resource brochure. Ongoing follow-up will occur until it is 
determined that risk is minimal.  
3. Potential Benefits of the Proposed Research to Human Subjects and Others 
It is believed that research participants may be helped by participating in this study. Participants who 
receive the CBTi-CB intervention will receive a therapeutic intervention aimed to improve their insomnia 
symptoms and related functioning during the day. CBT for insomnia has known risks associated with its use, 
but these are usually tolerable and subjects may not otherwise receive treatment for insomnia. Thus, the risks 
associated with participating are reasonable in light of the potential benefits to the participating subjects and 
others. The information control condition represents an increased (enhanced) level of care from standard 
medical cannabis treatment provided at clinics.  
4. Importance of the Knowledge to be Gained 

20 
 
The risks to subjects associated with participating are reasonable compared to the potential knowledge to 
be gained. Identifying an effective and safe non-medication treatment for insomnia, a highly common co-
occurring condition this population of individuals seeking cannabis, could improve nighttime and daytime 
symptoms and reduce cannabis use. Our study would be the first to evaluate a highly effective sleep-focused 
intervention and determine the effects on cannabis use in a non-treatment seeking population. 
Specific Aim 2: Conduct a pilot RCT comparing remotely -delivered CBTi-CB to remotely -delivered 
SE. 
Recruitment Procedures. Participants for the RCT phase will be recruited in various ways, including in-
person from two Michigan licensed cannabis provisioning centers (OM of Medicine and Bloom City Club), 
online at UMHealthResearch.org, in the community via flyers, on social media via Facebook and Instagram 
adds run by MICHR, and at community events. The cannabis provisioning centers (also known as 
dispensaries) are generally open during regular business hours and have waiting areas in which individuals 
can be approached. All potentially eligible individuals in the waiting rooms of the study sites on days of active 
recruitment will be invited to learn about the study and participate in eligibility screening. Participants who learn 
of the study through UMHealthResesearch.org will be contacted after matching with the project or indicating 
their interest in participating. Participants who learn of the study in the community via flyers and/or community 
events will reach out to staff or the UMHealthResearch.org site to learn more and will be followed up with via 
the website, email, or phone. A REDCap link to the screening survey will be available on paper flyers and via 
UMHealthResearch.org. A Facebook and Instagram paid, targeted ad (created by MICHR) will be pushed from 
the U-M Health Research Facebook page. This ad will be monitored by MICHR and study team. The MICHR 
Facebook page is entitled, Michigan Institute for Clinical & Health Research (MICHR).  
When enrolling participants in person or explaining the study via phone, research staff will follow the 
recruitment script. To enhance confidentiality and minimize the collection of identifying information about 
individuals who do not participate in the study, screening consent will be administered online or on study 
provided tablet computers as the first page of the screening survey (a waiver of documentation of informed 
consent for screening is requested). Since recruitment will occur online, in a waiting room of a dispensary, in 
the community, or at other UM locations, participants will be asked to complete the eligibility questions via a 
brief tablet screen (or paper version if the participant desires) or via online REDCap survey link to ensure their 
answers will be kept private. Prospective participants that use the online screening process will enter the 
survey portal from a link provided in the recruitment ad (paper or electronic) directing them to the 
UMHealthResearch.org site, where a link for the survey will be available. After clicking the survey link, they will 
then be asked to review and give e-consent to the short screening survey. During initiation of the screening 
survey each participant will be assigned a unique respondent ID number by REDCap. Participants will give 
consent by checking a box on the electronic consent form and will self-administer a screening survey. In the 
event of technological issues with study tablets or internet service, or participant preference, verbal consent 
may be obtained for screening and paper/pencil surveys completed. Following determination of eligibility, 
negative screens will receive a thank you page asking for a phone number or email address to be sent their gift 
card and ending their participation. The only identifying information collected from those who complete the 
online screening assessment and are ineligible or choose not to participate in the study will be an email 
address or phone number, to text or email Amazon gift card codes for screening assessment remuneration. 
This information will be deleted from the REDCap survey database after participants are sent their e-gift card. 
Those who are not eligible will be sent the e-gift card and thanked for their time.  
If participants screen eligible via the survey and were screened in person, they will be immediately asked to 
take a urine drug screen to detect THC and other illicit drug use. If participants are screened eligible via the 
survey and were screened online and are interested in participating further, they will be asked to provide their 
name, email address, and phone number for scheduling purposes. Study staff will reach out to eligible 
participants to schedule the urine drug screen and baseline assessment. This appointment can take place in 
person (when allowed) or online via video chat (BlueJeans, Skype for Business, or Zoom through the 

21 
 
University of Michigan) or by phone. If a participant declines to provide a urine sample or contact information to 
schedule a time for the urine drug screen and baseline, or if the results of the urine drug screen are negative 
for the presence of THC, they will be excluded from participating further. Participants will be given a small bag 
containing the test kit to take into a restroom at the recruitment/enrollment site(s). For participants who are 
unable or unwilling to provide a urine sample at the time of screening site, they may be given the option to 
complete the urine screen at a separate location (e.g. in the community or at the research office) or at their 
homes. As another option for those interested, especially with regard to COVID-19 pandemic risks, a urine 
drug screen will be mailed to the preferred address given by the participant. Research staff will use a video 
chat platform (BlueJeans, Skype for Business, or Zoom through the University of Michigan) to call the 
participant at the scheduled time, explain the urine drug screen to the participant, and ask them to go off 
camera to use the test. They will be asked to bring the test back to the video chat and show the results to the 
research staff on the call. This way, it is more likely the actual participant is the one using the urine drug 
screen. If the participant is unable to video chat with staff, they may send a picture of the urine drug screen 
results to the study email. The urine drug screen will provide information regarding recent use for opioids, 
cannabis, amphetamines, methamphetamines, and cocaine. Individuals who meet eligibility (individuals who 
report cannabis use for insomnia, suffer clinically significant insomnia, and have a positive urine drug screen 
for THC) based on their answers and urine drug screen will be invited to participate in the full study. 
Participants will be paid $10 cash, gift card, or e-gift card for completing the eligibility survey.  
Eligible participants will be invited to participate in the full study, involving a separate consent form. Potential 
participants will be asked to provide written (in-person recruitment) or verbal (remote recruitment) informed 
consent to the full study. Participants recruited remotely will be emailed or texted a copy of the consent form 
and research staff will review it with the them. Following the completion of the informed consent process for the 
full study, participants will be asked to complete the baseline assessment. Baseline assessments will include 
both a tablet/online-based survey (or paper/pencil version based on participant preference) and a researcher 
administered TLFB interview. Those who give verbal consent will continue by completing the locator form and 
Timeline Follow Back interview over video chat. These assessments will gather detailed evidence of problems 
related to sleep, frequency of recent substance use including cannabis use, substance use consequences, 
depression and self-efficacy. Because we will need to contact participants for completion of the daily surveys, 
therapy sessions, and follow-up assessments, the research staff member will collect detailed locator 
information. This information will include the participant’s phone number(s), address(es), e-mail addresses, 
and contact information for family members/friends who would know how to reach them. Participants will also 
be able to contact study staff or correspond/receive appointment reminders through text.  Because participants 
will complete several assessments remotely, we will set up a secure study e-mail account to be used for 
participants to contact study staff or for study staff to send appointment reminders and surveys to participants. 
The e-mail address is: UM-CannSleep@med.umich.edu.  
Following completion of data collection during the baseline assessment, participants will be randomized to a 
treatment condition – Sleep Hygiene Education (SHE; n=30) or Cognitive Behavioral Therapy for adults who 
currently use cannabis for insomnia (CBTi-CB; n=30). Randomization to condition will be carried out blocking 
on gender (male versus female). Participant responses to questions based on gender obtained during baseline 
will be utilized to select the appropriate block for randomization.  Research staff will confirm the participant 
responses before beginning the randomization procedures. “Gender” for randomization purposes will be 
operationalized as the gender the participants indicated they were assigned at birth; however, additional 
questions regarding the gender the participant identifies with will also be collected. Should a participant decline 
to answer a key blocking variable during the survey administration, research staff will verbally ask clarification 
questions to determine block assignment. If a participant refuses to provide information that allows for the 
possibility of blocking they will be excluded from participating further in the study.  
Computerized randomization will occur in blocks of randomly chosen sizes in order to equalize randomization 
over time and to prevent the possibility that staff could unwittingly manipulate subject assignment to conditions. 
The study biostatistician will complete the treatment allocation sequence process prior to the start of 

22 
 
recruitment for the study. Staff members who will be involved in the enrollment process will not be included in 
the randomization sequencing process. To further avoid manipulation of condition, randomization will not be 
determined until after all baseline data collection activities have been completed. We will utilize allocation 
concealment procedures to ensure that that research staff member enrolling the participant will not know in 
advance which treatment the next person will receive.  
Once generated, documents that include the randomization sequence will be password protected to avoid 
inadvertent access by research staff involved in the enrollment process.  The treatment condition assignments 
will be sealed in envelopes according to the allocation sequence by either the project coordinator or the study 
data manager prior to the beginning of study recruitment. The randomization process will be overseen by our 
study data manager and the project coordinator will be notified of assigned condition for specific participants at 
the completion of all baseline assessments (by opening sealed envelopes). Randomization should occur at the 
baseline enrollment appointment. Initiation of the study treatment condition (either CBTI-CB or SHE) should 
take place within one week of study enrollment and randomization in order to provide enough time for all 
sessions to be completed within the 6-8-week treatment window.  
Following randomization, the participants will be provided with an actigraph sleep monitoring watch if it is 
deemed safe by investigators and the University of Michigan Office of Research (UMOR). By “safe,” we mean 
that the risk of transmitting COVID-19 via the actigraphy watches or by going into the office to mail/pick 
up/configure watches is very low. This risk level is likely to change during the course of the study, and 
decisions will be made on a case by case basis at enrollment. Participants who are given the option to 
participate in actigraphy sleep data capture will have the option to decline and still participate in the full study. 
The actigraph (Actiwatch Spectrum Plus, Philips Respironics, Murrysville, PA) is a small waterproof device the 
size of wrist watch (48 mm x 37 mm x 15 mm weighing 31 grams) that is meant to be worn continuously on the 
non-dominant wrist. An accelerometer integrates movement frequency and intensity into a single 
measurement. In addition, a photodiode sensor continuously monitors incoming light and stores the data in lux 
levels. The actigraphs are set at a sampling rate of 30 seconds. Activity and light data are downloaded to 
computer and sleep/wake activity is estimated using Actiware® – Sleep software and following published 
guidelines. Data is accessed through the Actiware® – Sleep software and is identified by study participation ID. 
Participants will be asked to wear the actigraphy activity tracker for one-week (at least 7 consecutive days) 
post-enrollment, for at least one-week post-treatment (at approximately 8 weeks’ post-enrollment), and at least 
one-week pre final follow up (at approximately 16 weeks’ post-enrollment). Watches will be returned to the 
study team after the first 7 days of wear, returned to the participant after the last therapy session, collected by 
the study team at the follow up assessment, returned to the participant approximately 1 week before the final 
follow up assessment, and collected by the study team at that final assessment. To do so, we will ask 
participants to either 1. send the actigraphy activity tracker back in the mail using a prepaid envelope, 2. leave 
it in a drop box located at some of the recruitment sites, or 3. have study staff meet the participant at home or 
in the community to pick up or drop off the actigraphy activity tracker. Participants will be asked to wear the 
watch for at least 7 days post-treatment and again for at least 7 days pre- final follow up, and will return the 
watch at their in-person follow up or via mail after their electronic/mailed follow up is completed. Actigraphy 
activity trackers will come with informational brochures from the Philips Respironics company and pre-paid 
return envelopes for the participants to mail them back after both baseline and post-treatment assessment time 
points. Once the participant completes the survey, research staff will review the survey prior to the participant 
leaving the room to assess for risk status.  
Follow-up assessments will be conducted in person in the community, in our offices at the University of 
Michigan, or via emails containing REDCap survey links or mailed paper surveys where participants can 
complete surveys on their own. For those assessments that occur in the community, research staff will arrange 
to meet participants at a convenient and confidential location in the community (e.g., a local library, their 
home). If we interview a participant in his/her home, we will arrange for a second research staff member to go 
along for staff safety reasons. We have used this process successfully in our prior work with adults with SUD. 
For surveys that are taken online, appointments will be scheduled with participants for research staff to contact 

23 
 
them via a video chat platform (BlueJeans, Skype for Business, or Zoom through the University of Michigan) or 
via phone to complete the TLFB interview. 
Data Collection: Assessment content will measure demographic characteristics, reasons for seeking cannabis 
and current uses (must include insomnia), frequency and severity of insomnia, and presence of co-occurring 
exclusionary medical/psychiatric conditions, and other sleep disorders. The screening assessment will include 
questions that will allow for determination of eligibility.  Baseline assessments are intended to confirm eligibility 
and collect data on participants’ sleep, functioning, and substance use. Data will be collected via emailed 
surveys, tablets, paper, actigraphy, and urine drug screens.  
Specimens: In this study, we will be collecting urine to analyze for recent cannabis and other illicit drug use. 
The urine drug screen will provide information regarding recent use for opioids, cannabis, amphetamines, 
methamphetamines, and cocaine. We will be using urine testing kits that give immediate results; therefore, the 
study staff will be conducting the sample testing and no labeling or storage will be necessary. Participants will 
be given a small bag containing the test kit to take into a restroom, either at the recruitment/follow up location 
or at home, or they will be mailed a urine drug screen to use at home. Once the specimen has been provided 
in the test cup, the participant will either return the bag to the research staff member for immediate testing or 
schedule an appointment with research staff using a video chat platform (BlueJeans, Skype for Business, or 
Zoom through the University of Michigan) to use the urine drug screen off camera and immediately share the 
results with research staff. A final option is for participants to send a picture of the results to the secure study 
email. Research staff will record test results. After testing is complete, the urine sample will be discarded by 
flushing it down the toilet if done in person. No identifying information will be marked on the testing container. 
The validity of self-report of cannabis use and other illicit drug use may be increased when a urine drug screen 
is performed. Specimens will be collected in a specimen container about 4 oz. in size, although only a minimal 
amount of urine is needed.  
Assessment Instruments 
Screening/ 
Eligibility 
Baseline 
Before 
and/or 
after 
session 
Follow Up 
~8 weeks 
Follow 
Up ~16 
weeks 
Demographics 
X 
 
 
 
 
Alcohol, Smoking and 
Substance Involvement 
Screening Test (ASSIST) 
X 
 
 
 
 
Fagerstrom Test (for 
nicotine dependence) 
X 
 
 
 
 
Fagerstrom Test (for 
cannabis dependence) 
X 
 
 
 
 
Cannabis Use Disorder 
Identification Test 
(CUDIT) 
X 
 
 
X 
X 
Perceived Relief (PR) 
X 
 
 
X 
X 
STOP-BANG (Obstructive 
Sleep Apnea measure) 
X 
 
 
 
 
Restless Leg Syndrome 
Questionnaire (RLSQ) 
X 
 
 
 
 
Insomnia Severity Index 
(ISI) 
X 
 
 
X 
X 
Morningness/Eveningness 
Questionnaire  
 
X 
 
 
 

24 
 
Urine Drug Screen  
X 
 
 
X 
X 
Personal Health 
Questionnaire Depression 
Scale (PHQ-8) 
 
X 
 
X 
X 
12-Item Short Form 
Health Survey (SF-12) 
 
X 
 
X 
X 
Timeline Follow Back 
 
X 
 
X 
X 
Modified Self Efficacy 
Scale (SES) 
 
X 
 
X 
X 
Dysfunctional Beliefs 
About Sleep (DBAS-16) 
 
X 
 
X 
X 
Substance Use Sleep Scale 
(SUSS) 
 
X 
 
X 
X 
Modified Marijuana 
Motives Questionnaire 
(MMQ) 
 
X 
 
 
 
Medical Marijuana Use 
 
X 
 
 
 
Prescription Misuse 
(BOYD) 
 
X 
 
X 
X 
Side Effect Checklist 
(SECL) 
 
X 
 
X 
X 
Marijuana withdrawal 
checklist revised (MWC-R) 
 
X 
 
X 
X 
PEG Three-item Scale 
Assessing Pain Intensity 
and Interference 
 
X 
 
X 
X 
BRFSS Model 
16(Marijuana Use Type) 
 
X 
 
X 
X 
Multidimensional Fatigue 
Inventory (MFI-20) 
 
X 
 
X 
X 
Epworth Sleepiness Scale 
 
X 
 
X 
X 
Therapy Evaluation 
Questionnaire 
 
X 
 
X 
 
Working Alliance 
Inventory-SR 
 
 
 
X 
 
Daily Sleep/Wake Diary 
 
X 
X 
X 
X 
Actigraphy 
 
X 
 
X 
X 
Session Attendance 
 
 
X 
X 
 
 
Primary outcomes: The ultimate goal is to use this pilot study to provide all of the necessary elements to 
conduct a future fully-powered RCT comparing these two conditions. We hope to assess the acceptability and 
feasibility of RCT procedures to determine the distribution and variability of the primary outcomes (insomnia 

25 
 
severity). This will be measured by the change from baseline Insomnia Severity Index score to the score at 
study completion. 
All remuneration for the study will be in the form of gift cards or cash. Participants will be remunerated with a 
$40 for the completion of baseline assessment, $40 for completion of each follow-up assessment, $20 for 
completing four out of seven days of the daily online survey for every week before the first follow up and $10 
for completing four out of seven days of the daily online survey for the week before the 2nd follow up, plus an 
additional $10 incentive for a urine drug screen at both follow ups. Participants will also receive $30 to 
compensate them for any potential charges related to the use of their technology. Participants who do not 
complete all therapy sessions will still receive the $30 to cover technology costs, however, they must have 
completed at least one phone session.  
Informed consent. A two-level consent procedure will be used in this study.  At screening and baseline, 
participants will be asked to provide informed consent. After screening, those eligible will be asked to complete 
a second consent. To enhance confidentiality and minimize the collection of identifying information about 
individuals who do not participate in the study, screening consent will be administered online (a waiver of 
documentation of informed consent for screening is requested) or on study provided tablet computers as the 
first page of the screening survey. Prospective participants that use the online screening process will enter the 
survey portal from a link provided in the recruitment ad (paper or electronic) directing them to the 
UMHealthResearch.org site, where a link for the survey will be available. After clicking the survey link, they will 
then be asked to review and sign an e-consent to the short screening survey. During initiation of the screening 
survey each participant will be assigned a unique respondent ID number by REDCap. Participants will give 
consent by checking a box on the electronic consent form and will self-administer a screening survey. In the 
event of technological issues with study tablets or internet service, or participant preference, verbal consent 
may be obtained for screening and paper/pencil surveys completed. Following determination of eligibility, 
negative screens will receive a thank you page asking for a phone number or email address to be sent their gift 
card and ending their participation. The only identifying information collected from those who complete the 
screen and are ineligible or choose not to participate in the study will be an email address or phone number, to 
text or email Amazon gift card codes for screening assessment remuneration. Eligible participants will be 
asked to provide their name, email address, and phone number for scheduling purposes. Study staff will reach 
out to eligible participants to schedule the urine drug screen and baseline assessment. 
For those eligible based on screening responses and interested in participating in the full study, written or 
verbal informed consent for the full study will be obtained. Individuals interested in participating in the study will 
review the consent that will be emailed, texted or handed to them with the research staff in person or via a 
video chat platform (BlueJeans, Skype for Business, or Zoom through the University of Michigan). All 
participants will be told that participation is voluntary, that they can withdraw at any time, and that this will not 
impact any aspect of the services they receive at the clinics or dispensaries, including their ability to receive 
cannabis (if recruited from dispensaries). After reviewing the consent form, research staff will ask the patient if 
he/she has any questions regarding their participation or the study requirements and limitations. The limits of 
the Certificate of Confidentiality are explained in the consent form, but study staff will also verbally explain the 
limits of confidentiality. Any patients who request more time to review the consent form or consult with others 
will have the opportunity to do so. These patients will have the opportunity to have research staff contact them 
at a later time or to contact research staff themselves. Those interested in participating will be asked to  
consent to the research project. When providing informed consent, participants will be given, mailed or emailed 
a copy of the consent form to keep and the original will be filed in a confidential research file or study staff will 
record the date, time, and research staff conducting the consent in the secure database. Study staff will review 
the consent form for accuracy and completeness before beginning any study procedures. RAs will fully review 
the consent document, answer all questions and provide a copy of the consent document to the participant.  All 
consent information will be filed in a confidential research database.  
Study Eligibility Criteria. 

26 
 
Inclusion criteria. (1)  age > 21 or older; (2) Insomnia Severity Index (ISI) score >10, indicative of at least 
“mild” insomnia; (3) use of cannabis three times a week within the past three months; (4) self-reported use of 
cannabis to manage insomnia at least once a week over the past month; (5) consistent access to a telephone, 
smartphone, laptop, or tablet; and (6) a positive urine drug screen for THC. 
 
Exclusion criteria. (1) individuals who do not understand English; (2) individuals judged unable to provide 
informed consent (e.g., intoxication, mental incompetence, psychosis, bipolar disorder); (3) diagnosis or high 
suspicion of a sleep disorder other than insomnia based on validated self-report measures; (4) self-reported 
cancer; (5) self-reported pregnancy; (6) self-reported rotating or night (3rd) shift work; (7) resides a distance 
greater than 50 miles from Ann Arbor. Participants will not be excluded if they are taking prescription or over 
the counter medications for sleep, however they will need to report being stable on the medications for at least 
8 weeks and agree to maintain the same regime throughout the study. Those who have been taking 
prescription medications for sleep for less than 8 weeks, or who report they are unable to continue with their 
medications for the duration of the study (approximately 16-18 weeks) will be excluded.   
Research staff will use their clinical judgment to assess cognitive ability to consent. If necessary, recruitment 
staff may require a potential participant to pass a brief mental status exam. Potential participants may be 
excluded based on participant best interest (e.g., adult patient with a legal guardian; or if study staff know a 
patient or their family personally, in order to fully ensure participant privacy), with PI approval. 
Justification for selection criteria. Participants in this study will be 21 years old and older for several 
reasons. First, although state law does allow individuals under the age of 18 to obtain cannabis for medical 
purposes with consent of a legal guardian, available data indicate that very few adolescents have been issued 
medical cannabis cards in Michigan. In addition, with the new recreational marijuana laws allowing non-
medical use of cannabis, we are not solely recruiting medical cannabis users. This new law states all 
recreational marijuana uses must be 21 years or older to possess or use marijuana. Therefore, all participants 
should be age 21 years or older to follow Michigan recreational marijuana laws. 
In order to collect interview data from a sample that will be representative of the population to be recruited for 
the RCT, we will exclude those with self-reported cancer or pregnancy. Individuals who use marijuana for 
cancer may experience a different trajectory than those who are not and women who self-report that they are 
pregnant will be excluded because: (a) of the potential risks of study participation to pregnant women; and (b) 
we are unlikely to have sufficient numbers of pregnant women to facilitate meaningful subgroup analyses. 
Access to a smartphone, computer, or tablet is required to deliver intervention sessions, as all sessions are 
meant to be delivered remotely via BlueJeans video chat or telephone. Those who do not report having 
reasonable access to the technology needed for the study will be excluded.  
 
Potential Risks, Minimizing Risks, and Potential Benefits 
1. Potential Risks 
a.  Loss of Confidentiality 
 
The major potential risk to study participants is violation of confidentiality of survey and interview data. The risk 
of violation of confidentiality exists because participants will be disclosing personal information in surveys and 
interviews. This risk is related to the damage that could be caused by an inadvertent release of sensitive 
information (e.g., substance use, medical conditions). Participants will be informed of the procedures taken to 
protect their confidentiality.  

27 
 
 
 
b. Discomfort During Interview 
There is also a slight risk of psychological discomfort to study participants as a result of being asked personal 
questions on sensitive topics. Participants may also become anxious or upset during discussions of their 
thoughts about managing their insomnia or substance use during the interview.  
2. Minimizing risk 
 
a. Loss of confidentiality (risk unlikely)  
To minimize the violation of confidentiality, we will ensure that data are protected and cannot be linked to a 
particular person. Unique identification numbers will be assigned to each participant and all forms are coded 
with this number, rather than by name. All data are stored in locked file cabinets. Consent forms and subject 
code/name sheets will be stored separately, because they contain identifying information. Data entry staff will 
work with forms that contain only subject numbers.  Physical security of data will be assured by daily and 
weekly back-ups. Data cleaning will be conducted throughout the data collection period to ensure the 
production of a final dataset for analysis at the end of data collection.  
 
Study data will be collected and managed using REDCap (Research Electronic Data Capture). Participants’ 
names and contact information will be stored in a secure, REDCap database, separate from their study data 
and only accessible to members of the research team for research purposes. REDCap is a secure web 
application designed to support data capture for research studies. It provides userfriendly web-based case 
report forms, real-time data entry with branching logic and validation (e.g. for data types and range checks), 
audit trails, a de-identified data export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-
Plus), procedures for importing data from external sources, and advanced features such as a data quality 
check module. The system was developed by a multiinstitutional consortium initiated at Vanderbilt University. 
REDCap servers are physically located in the University of Michigan Medical School Information Systems 
(MSIS) data center. Application and database servers are on virtual machines (VM). The VM servers are Red 
Hat Enterprise Linux Server 5.6 (64-bit, 2.6.18 238 e15-smp kernel) 2x AMD Opteron 6174 5.0.95 2.2 GHz 
with 4 GB RAM, running Apache 2.2.3 (application servers) and MySQL (database servers). Physical security 
for the databases is provided in a professionally managed and equipped tier-2 data center with tightly 
controlled access. Remote data access employs SSL encryption and 2-tier Kerberos/Level 1 and UMHS Level 
2 password challenges via LDAP authentication. Access to the application, the database, and the underlying 
systems infrastructure are consistent with industry best practices including HIPAA security and privacy 
requirements and the HITECH Act. The applicationprovides audit trails on user access to MICHR and MSIS 
technical and support teams. Backup of data is managed by MSIS and vulnerability testing is performed 
regularly by the University of Michigan Health 
System Medical Center Information Technology. Risk evaluation is performed using a methodology 
derived from NIST Special Publication 800-53 – “Recommended Security Controls for Federal Information 
Systems” and is used to refine and improve operating policies and procedures. Daily backups and VM 
snapshots of the application and database servers are stored on a remote storage device. The restoration of 
the servers from a hardware or software failure are protected for 24 hours of disaster recovery.  
 
To test a new participant tracking program, participant personal information will also be kept in Ripple™, a 
secure web application designed for the storing and management of personally identifying information of 
research participants. Ripple was initially developed at the University of Michigan to provide a user-friendly, 
web-based secure interface where research teams can centralize the storage and management of research 
participants’ personal information, including name, participant ID, demographics, and study workflow (e.g., 
appointments). Participant information managed with ripple is private and secure. This information is kept in 

28 
 
fully encrypted format inside dedicated databases that are segregated from other Ripple accounts and thus 
only authorized study staff will have access to the study data. Likewise, Ripple infrastructure complies with the 
privacy and security guidelines of the Health Insurance Portability and Accountability Act (HIPAA), including 
2048-bit data encryption in transit and at rest, automatic logoff, audit trail, daily backups in triplicate dedicated 
servers, firewall, custom access permission for lab members, zxcvbn password strength estimation, and 
enterprise administrative safeguards to prevent unauthorized staff from accessing participant information. 
Furthermore, Ripple is used only for storing personally identifiable information of participants and is not used to 
capture other research data (e.g., questionnaires, health records, etc.). This ensures that the personally 
identifiable information and research data are segregated. As this is a pilot program, Rippple is only available 
to us for approximately 6 months of use. To avoid any data loss, participant tracking information will also be 
kept in REDCap, as mentioned above and as previously done in the beta testing phase of this project.  
 
Interviews will be audio-recorded with participant permission for fidelity and may take place in person, via an 
online video chat (BlueJeans), or over the phone. The intervention sessions may be remotely delivered via 
telephone or BlueJeans video conferencing (https://www.bluejeans.com/). BlueJeans provides a cloud-based 
audio/video/content-sharing conferencing service. The service is vendor-agnostic and allows up to 150 
endpoints to connect for a meeting. U-M's current contract with BlueJeans enables all U-M faculty, staff, and 
students to register for a BlueJeans User Account. BlueJeans collects and maintains data related to the date, 
time, and attendees of a meeting. Actual video or audio content is only stored by BlueJeans when the meeting 
host turns on the recording feature. We will not be using the recording feature on Bluejeans. U-M's agreement 
with BlueJeans includes a Business Associate Agreement. This means individuals may use this service to 
share Protected Health Information (PHI) regulated by HIPAA. For more information, BlueJeans Security and 
Privacy agreements with the University of Michigan can be found at 
https://safecomputing.umich.edu/dataguide/?q=node/181. The audio recordings for the interviews will be done 
with a digital voice recorder. The audio-recordings of the interviews will be destroyed after the files are 
uploaded to a password-protected, secure server with restricted access. Participants will be asked not to 
mention names or other identifying information in during the recorded interview. Due to an increase in use in 
the BlueJeans platform during the COVID-19 pandemic, we are also including the ability for research staff to 
use alternate video platforms approved by the University of Michigan, including Skype for Business, or Zoom 
through the University of Michigan. 
 
We have set up an email account to be used for subjects to contact study staff or for study staff to send 
appointment reminders and online surveys (via REDCap) to subjects. The e-mail address is: UM-
CannSleep@med.umich.edu. 
b) Discomfort during assessments (risk likely): 
Participants may become upset, anxious, or uncomfortable as a result of being asked very personal questions. 
To minimize this risk, all interviews will be conducted in private offices with skilled research staff. Research 
assistants will be trained to respond to this emotional distress and to refer participants to appropriate resources 
as necessary. Specifically, this training will include information regarding evaluating warning signs of distress 
that could occur as a result of the screening, intervention, or assessments, and means of addressing such 
issues and minimizing distress. Such strategies will include maintaining an empathic response, acknowledging 
the distress through reflection, avoiding blame, processing in a non-blaming non-confrontational manner, and 
eliciting or encouraging use of relaxation and cognitive calming strategies. Crisis procedures, effective in 
previous projects conducted by the study investigators, will also be utilized, including immediately paging Drs. 
Ilgen or Arnedt (Multiple PIs) for consultation. If any research staff observes any indication of potential distress, 
including through review of responses to the assessments, further evaluation of the participant will be 
conducted by a licensed clinician.  All participants are free to terminate the interview at any time or refuse to 
respond to any question. As with any research project, unexpected events are always possible. If risk is 

29 
 
determined to be present, we will implement our standard clinical protocol for responding to suicide risk, 
including giving participants a resource brochure. Ongoing follow-up will occur until it is determined that risk is 
minimal.  
3. Potential Benefits of the Proposed Research to Human Subjects and Others 
It is believed that research participants may be helped by participating in this study. Participants who receive 
the CBTi-CB intervention will receive a therapeutic intervention aimed to improve their insomnia symptoms and 
related functioning during the day. CBT for insomnia has known risks associated with its use, but these are 
usually tolerable and subjects may not otherwise receive treatment for insomnia. Thus, the risks associated 
with participating are reasonable in light of the potential benefits to the participating subjects and others. The 
information control condition represents an increased (enhanced) level of care from standard medical cannabis 
treatment provided at clinics.  
4. Importance of the Knowledge to be Gained 
The risks to subjects associated with participating are reasonable compared to the potential knowledge to be 
gained. Identifying an effective and safe non-medication treatment for insomnia, a highly common co-occurring 
condition this population of individuals seeking cannabis, could improve nighttime and daytime symptoms and 
reduce cannabis use. Our study would be the first to evaluate a highly effective sleep-focused intervention and 
determine the effects on cannabis use in a non-treatment seeking population. 
 
 

30 
 
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Hasin DS, Saha TD, Kerridge BT, et al. Prevalence of Marijuana Use Disorders in the United States 
Between 2001-2002 and 2012-2013. JAMA psychiatry. 2015;72(12):1235-1242. 
2. 
http://www.samhsa.gov/data/population-data-nsduh. 
3. 
Lin LA, Ilgen MA, Jannausch M, Bohnert KM. Comparing adults who use cannabis medically with those 
who use recreationally: Results from a national sample. Addict Behav. 2016;61:99-103. 
4. 
Jager G, Kahn RS, Van Den Brink W, Van Ree JM, Ramsey NF. Long-term effects of frequent 
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