Remote Guided Caffeine Reduction
Phase: NA
Conditions: Caffeine Dependence, Anxiety, Sleep Disturbance, Gastrointestinal Dysfunction, Sleep Initiation and Maintenance Disorders, Caffeine; Sleep Disorder, Caffeine, Caffeine-Induced Anxiety Disorder, Caffeine Withdrawal, Caffeine-Induced Sleep Disorder, Without Use Disorder, Caffeine Abuse, Insomnia, Anxiety Disorders, Sleep Disorder, Heartburn, Diarrhea
Sponsor: Johns Hopkins University

 
 
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REMOTE GUIDED CAFFEINE REDUCTION 
 
Protocol 
 
NCT04560595 
 
02/07/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Date:  2/7/2022 
 
Principal Investigator:  Dustin Lee, Ph.D. 
 
Application Number:  IRB00250925  
 
 
 
 
JHM IRB - eForm A – Protocol 
 
 
 
• Use the section headings to write the JHM IRB eForm A, inserting the appropriate material 
in each. If a section is not applicable, leave heading in and insert N/A. 
• When submitting JHM IRB eForm A (new or revised), enter the date submitted to the field at 
the top of JHM IRB eForm A. 
 
**************************************************************************************
************* 
 
 
1. 
Abstract 
a. Provide no more than a one page research abstract briefly stating the problem, the research 
hypothesis, and the importance of the research. 
 
There is emerging evidence that some individuals have difficulty cutting down or eliminating their 
caffeine consumption in spite of clinically significant problems exacerbated by caffeine use. Some 
of the most commonly reported caffeine-related problems are anxiety, insomnia, and 
gastrointestinal distress. However, prior in-person trials examining the benefits of a gradual, 
manualized caffeine reduction program did not specifically measure improvement in these 
symptoms before and after caffeine reduction. We recently led an in-person clinical trial examining 
the effects of a very brief intervention to provide instructions for a gradual, manualized caffeine 
reduction program in individuals with DSM-defined problematic caffeine use. We found that as a 
result of our brief intervention, participants were successful at reducing caffeine use. However, we 
did not measure symptoms improvement with respect to anxiety, insomnia, or gastrointestinal 
distress, in spite of the fact that these are common problems that can be exacerbated by caffeine. 
This time- and cost-effective, very brief intervention may be ideal to implement remotely (i.e., 
online), but the acceptability and feasibility of a remote intervention has not yet been assessed. In 
the proposed study, we will implement our brief, manualized caffeine reduction intervention 
entirely remotely (online), and determine to what extent: 1. participants will engage with a remote 
caffeine reduction intervention and find it acceptable, 2. participants are able to reduce their 
caffeine use, 3. participants report improvement in common caffeine-related problems (e.g., anxiety, 
insomnia, or gastrointestinal concerns), and 4. participants randomized to the immediate 
intervention group (at 7 weeks post enrollment and treatment) show greater caffeine reductions or 
greater improvements in caffeine-related problems relative to the delayed treatment group at 7 
weeks post-enrollment (before treatment). Participants will complete four remote visits (Screening, 
Treatment, Week 7 Follow-up, Week 14 Follow-up) via HIPAA-compliant Zoom meetings created 
by study staff or through other approved Johns Hopkins Telemedicine Services (e.g., Polycom). 
Participants will complete surveys/intake assessments via shareable JHMI-credentialed Qualtrics 
links provided to them by the study staff during remote meetings and weekly via email/text during 
the gradual caffeine reduction period (Weeks 1-6). Participants will provide contact information for 
a community observer who will be sent email links to complete two surveys via shareable JHMI-

 
 
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credentialed Qualtrics links provided to them by the study staff. Our study staff is experienced in 
implementing Qualtrics surveys remotely in prior studies and has extensive experience providing 
brief intervention for caffeine reduction using the manual-only approach. These data will support 
feasibility and initial efficacy of future randomized controlled trials in populations experiencing 
specific caffeine-related problems. 
 
2. 
Objectives (include all primary and secondary objectives) 
 
Primary objective. Determine to what extent participants will engage with a remote caffeine reduction 
intervention for caffeine-related problems and find it acceptable. 
 
Secondary objective (a). Determine to what extent participants are successfully able to reduce their caffeine 
consumption following the remote intervention. 
 
Secondary objective (b). Determine to what extent participants report improvement in common caffeine-
related problems (e.g., insomnia, anxiety, gastrointestinal distress) following the remote intervention. 
 
Secondary objective (c). Determine whether participants randomized to the immediate intervention group 
(at 7-weeks post enrollment and post-treatment) show greater caffeine reductions or greater improvements 
in caffeine-related problems relative to the delayed treatment group at 7-weeks post-enrollment (prior to 
delayed treatment). This randomization will allow us to compare the initial efficacy of our intervention 
with caffeine reductions that may occur spontaneously over the same duration. 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with procedures, 
drug or device, and any other relevant information to justify the research) 
 
An estimated 89% of adults in the United States consume caffeine daily (Fulgoni et al., 2015). Although 
moderate caffeine consumption is not generally associated with negative health consequences (Nawrot et 
al., 2003; Wykoff et al., 2017), approximately 14% of adults consume more than the recommended limit of 
400 mg of caffeine per day (Fulgoni et al., 2015; USDA, 2015). Caffeine may negatively affect conditions 
such as anxiety, insomnia, tachycardia, urinary incontinence, gastrointestinal upset, and is associated with 
complications during pregnancy (see Temple et al., 2017 or Sweeney et al., 2018 for review). It is common 
for physicians or other medical professionals to recommend reduction of caffeine use for individuals who 
have contraindicated psychological or medical conditions (Hughes et al. 1988; Griffiths and Reissig, 2008). 
Further, a large percentage of caffeine users in the general population report a desire or unsuccessful efforts 
to stop or reduce caffeine use (Hughes et al., 1998; Sweeney et al., 2020). 
 
In spite of the widespread use of caffeine, and growing recognition that some caffeine users experience 
caffeine-related problems, few studies have been conducted to develop and validate caffeine cessation 
treatments. Gradual reduction of caffeine over a period of several weeks has shown to be effective in prior 
controlled studies with heavy caffeine users and individuals with urinary incontinence (James et al., 1985, 
1988; Foxx & Rubinoff, 1979; Bryant et al., 2002; Bernard et al., 1981). Further, two recent investigations 
from our laboratory treated participants and characterized their problematic caffeine use according to DSM 
criteria. Evatt, Juliano, and Griffiths (2016) evaluated a gradual caffeine cessation treatment among 
individuals seeking treatment for problematic caffeine use using a wait-list control design. Participants 
received a 1-hour in-person counseling session and received a manual incorporating cognitive-behavioral 
strategies to reduce caffeine consumption over a period of 5 weeks. On average, treatment resulted in 
significant reductions in self-reported caffeine use and salivary caffeine following the manualized 
intervention, with no significant increases in self-reported caffeine use observed for up to 1 year follow-up. 
 

 
 
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Because the requirement of a 1-hour individual counseling session as in Evatt et al. (2016) may still be 
considered burdensome for health care professionals with limited time and expertise dedicated to 
behavioral interventions, we recently completed a follow-up study examining examined the efficacy of 
simplified, manual-only treatment for caffeine reduction and cessation in individuals seeking treatment for 
their caffeine use (Sweeney et al., 2019). Individuals meeting at least two proposed DSM-5 diagnostic 
criteria for Caffeine Use Disorder were randomly assigned to receive either immediate treatment or 
treatment delayed by 7 weeks. The treatment consisted of an in-person meeting, at which study staff 
provided a manual containing information about caffeine and instructions for gradually reducing caffeine 
consumption over a period of 6 weeks. No counseling or additional support was provided. Caffeine 
consumption and caffeine-related distress was assessed before treatment and 7 weeks after receiving the 
treatment manual (End-of-Treatment) during in-person meetings, and 20 weeks post-treatment via phone. 
The treatment resulted in significant reductions in participants’ caffeine consumption and caffeine-related 
distress at End-of-Treatment that were sustained at 20 weeks post-treatment. Comparisons between the 
immediate and delayed treatment groups suggest the treatment effects were attributable to the manualized 
treatment rather than spontaneous with the passage of time. Feedback from volunteer-nominated 
community observers in both groups provided further evidence for participant self-reported caffeine 
reduction. 
 
This efficacious, very brief, manual-only intervention for caffeine reduction is time- and cost-effective, and 
may be an ideal candidate for use through remote (online) implementation. However, the feasibility, 
acceptability, and initial efficacy of a remote intervention remains to be determined. In the proposed study, 
we will extend this line of research to determine to what extent: 1. participants will engage with a remote 
caffeine reduction intervention and find it acceptable, 2. participants are successfully able to reduce their 
caffeine consumption, and 3. participants report improvement in common caffeine-related problems. 
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
There will be no in-person visits for the proposed study. Study interactions will be conducted entirely 
remotely via JHMI-credentialed Qualtrics surveys, HIPAA-compliant Zoom meetings created by study 
staff (i.e., using the JHMI HIPAA-compliant instance), or through other approved Johns Hopkins 
Telemedicine Services (e.g., Polycom). The present study will consist of a preliminary online screening 
(via JHMI-credentialed Qualtrics survey), followed by a more detailed screening televisit for those 
individuals who meet preliminary screening criteria. Individuals determined to be eligible following the 
screening televisit will complete three additional televisits: Treatment, Week 7 follow-up, and Week 14 
follow-up. Participants will provide contact information for a community observer who will complete two 
online surveys, one near the Treatment visit and one near the Week 7 follow-up. Between the treatment visit 
and the Week 7 follow-up, participants will complete online surveys once per week. In Table 1 below, we 
provide a summary of the assessments to be administered at each study time point. Detailed measures and 
descriptions are also appended to the current application in the “Measures” document. 
Preliminary Screening. We have created a preliminary screening survey assessing basic 
demographics and initial eligibility via JHMI-credentialed Qualtrics survey. Links to the survey will be 
provided via online or paper flyer advertisements (e.g., Psychiatry department website, Google/Facebook 
ads) or in response to email/telephone inquiry. Individuals who complete the preliminary screening and 
indicate interest in participation will provide their first name and telephone number as part of the survey. 
Individuals who meet initial eligibility criteria will be contacted via phone to determine a time for the 
screening televisit and to receive instructions. 
Screening Televisit. Study staff will create a HIPAA-compliant Zoom meeting with the participant, 
or using other approved Johns Hopkins Telemedicine Services (e.g., Polycom) in the event of technical or 
other issues with Zoom. The visits will be password-protected and will require the participant to use video 

 
 
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during the call. Study staff will also use video whenever possible. The study staff will use the Zoom chat 
function or email to send the participant survey links and will verbally instruct them on how to complete 
the surveys, beginning with the consent survey. The oral consent form document will be embedded within 
the Qualtrics survey such that the participant can download the consent form document, or alternatively 
may be emailed to the participant. The study staff will ask the participant to read aloud the first part of the 
consent form in order to confirm that they were able to download the document and are able to read English 
fluently. Then the participant will be provided the opportunity to review the document and ask the study 
staff any questions they have about participation. This will be followed by a consent quiz administered via 
Qualtrics survey link. Participants will provide oral consent and answer all of the consent quiz questions 
correctly prior to proceeding with the remaining screening questionnaires. Following consent, participants 
will complete standardized medical/substance use history questionnaires as well as surveys to determine 
their caffeine/cigarette use, caffeine-related problems, and standardized assessments of anxiety, sleep, and 
gastrointestinal problems as outlined in Table 1. The participant will fill out the surveys via Qualtrics links, 
or the study staff will interview them and enter their responses on the study staff computers. Study staff 
will provide instructions to guide them through the assessment completions, review their responses on 
Qualtrics, and may ask follow-up questions if necessary, to supplement their survey responses. After 
determining eligibility, participants will be randomized to either the Immediate or Delayed treatment group 
using an urn randomization procedure accounting for caffeine consumption, age, and sex as was utilized in 
prior research in our laboratory (Evatt et al., 2016; Sweeney et al., 2019). 
Community Observer. During the screening or treatment visit, participants will be asked to provide 
the name and contact information (phone number and email address; email will be the preferred method of 
contact) for a family member, friend, roommate, or significant other for the purposes of online surveys 
about their caffeine use. The participant will be asked to confirm with their observer that the study team has 
permission to contact them. The observer will be contacted twice to complete a brief online survey 
regarding the participants’ caffeine use. The first contact will occur soon after the participant has the 
Treatment visit. The second contact will occur near the time of the participant’s Week 7 follow-up visit. 
Treatment Televisit. Participants determined to be eligible following the screening televisit will be 
scheduled to complete the treatment televisit shortly after screening. For the immediate treatment group, 
the treatment the Treatment visit will generally occur within one week of the screening televisit. The 
delayed treatment group will have their Treatment visit scheduled for a date approximately 7 weeks after 
screening. During the Treatment televisit, study staff will provide the participants with a digital copy of the 
caffeine reduction treatment manual used in prior studies (Evatt et al., 2016; Sweeney et al., 2019). As in 
prior research (Sweeney et al., 2019), study staff will give a brief (i.e., generally less than five minutes) 
description of the manual and instructions on how to gradually reduce their caffeine consumption over a 
period of six weeks. Participants will also complete assessments to determine their caffeine consumption 
and cigarette use over the past 7 days as outlined in Table 1. Participants will also be provided with 
information about their follow-up visits and how to complete weekly surveys. 
Weekly Surveys. At seven days following the treatment televisit, participants will receive a request 
to complete a survey via Qualtrics link sent via email/text. The survey will consist of standard assessments 
of anxiety, depressed mood, sleep problems, gastrointestinal problems, past week caffeine/cigarette intake, 
and problems related to caffeine as outlined in Table 1. They will receive a request to complete the same 
survey once per week (weeks 1-6) until the Week 7 follow-up televisit. 
Week 7 Follow-up Televisit. At approximately 7 weeks after the treatment televisit, participants will 
complete a follow-up televisit at which they will complete the same measures as previously administered to 
assess anxiety, depressed mood, sleep problems, gastrointestinal problems, past week caffeine/cigarette 
use, and caffeine-related problems as outlined in Table 1. Participants will also complete a treatment 
acceptability survey. 
Week 14 Follow-up Televisit. Finally, participants will complete a follow-up visit approximately 14 
weeks after the treatment televisit. They will complete all the same assessments as the Week 7 televisit, 
except they will not repeat the treatment acceptability survey. 
 
 

 
 
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Table 1. Study measures according to visit 
 
Preliminary 
Online 
Screening 
Screening 
Televisit 
Treatment 
Televisit 
Weekly 
Surveys 
(Weeks 
1-6) 
Week 7 
Televisit 
Week 14 
Televisit 
Basic screening questions/demographics1 
X 
 
 
 
 
 
Typical Week Caffeine Survey 
X 
 
 
 
 
 
AUDIT-C2 
X 
 
 
 
 
 
DAST-103 
X 
 
 
 
 
 
PROMIS-Anxiety-8a4 
X 
 
 
X 
X 
X 
PROMIS-SleepDisturbance-8a4 
X 
 
 
X 
X 
X 
PROMIS-GIDiarrhea-6a4 
X 
 
 
X 
X 
X 
PROMIS-GIReflux-13a1.04 
X 
 
 
X 
X 
X 
PROMIS-Depression-8a4 
X 
 
 
X 
X 
X 
Consent Quiz1 
 
X 
 
 
 
 
Medical History Survey1 
 
X 
 
 
 
 
Drug Use History Matrix1 
 
X 
 
  
  
  
Caffeine Timeline Follow-back1 
 
X 
X 
 
X 
X 
Past 7 Days Caffeine Survey1 
 
X 
X 
X 
X 
X 
Past 7 Days Cigarette Survey (smokers 
only) 1 
 
X 
X 
X 
X 
X 
Caffeine Problems Survey1 
 
X 
 
 
 
 
Caffeine Use Disorder Questionnaire1 
 
X 
 
X 
X 
X 
Caffeine Use Disorder Interview1 
 
X 
 
 
 
 
GAD-75 
 
X 
 
 
X 
X 
PSQ-I6 
 
X 
 
 
X 
X 
Insomnia Severity Index7 
 
X 
 
 
X 
X 
GSRS8 
 
X 
 
 
X 
X 
Treatment Acceptability Survey/Interview1 
 
 
 
 
X 
 
Observer Rating Survey  
(Completed by Community Observer)1 
 
 
X 
 
X 
 
Note. Detailed descriptions of all measures are appended to the present IRB application in the “Measures” document. 1Study 
team-generated measure/survey based on prior research (e.g., Sweeney et al. 2019, 2020). 2Alcohol Use Disorders Identification 
Test-C, Bush et al., 1998. 3Drug Abuse Screening Test, Skinner 1982. 4Patient-Reported Outcomes Measurement Information 
System, Cella et al., 2010, Rothrock et al., 2010. 5Generalized Anxiety Disorder-7, Spitzer et al., 2006. 6Pittsburgh Sleep Quality 
Index, Buysse et al., 1989. 7Bastien et al., 2001. 8Gastrointestinal Symptom Rating Scale, Svedlund et al., 1988. 
 
b. If your study involves data/biospecimens from participants enrolled under other research studies 
with a written consent or under a waiver of consent, please list the IRB application numbers for 
those studies.  Please note:  Certificate of Confidentiality (CoC) protections applied to the data 
in source studies funded by NIH or CDC will extend to this new study if the funding was active 
in 2016.  If this situation applies, Section 36, question 4 in the application will need to be 
answered “Yes” and “Hopkins Faculty” should be selected in question 7. No other documents 
are required. 
 
This study does not involve data or biospecimens from participants enrolled in other research studies. 
 
c. Study duration and number of study visits required of research participants. 
 
Participants will be asked to complete online preliminary screening via Qualtrics survey, four televisits 
(screening, treatment, 7 week follow-up, 14 week follow-up), and complete six surveys over six weeks 

 
 
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(weeks 1-6 following treatment televisit), as described in detail above in study procedures and in Table 1. 
The screening televisit is anticipated to take less than 1.5 hours. All other televisits are expected to take less 
than 30 minutes. The six weekly surveys (weeks 1-6 following treatment televisit) are anticipated to take 
approximately 5-10 minutes once per week. The anticipated study duration is approximately 15 weeks from 
the time of the screening televisit to the final televisit at 14-weeks for those in the immediate intervention 
group. For those in the delayed intervention group, the anticipated study duration is approximately 21 
weeks due to the programmed delay between the screening televisit and the treatment televisit. The 
duration of participation will be in part dependent on participant and study staff scheduling and availability. 
There is no evidence to suggest that the difference in timing of visits and measures will adversely affect the 
participants or the validity of the study.  On those occasions on which the timing of meetings, sessions or 
measures deviate substantially from the time frames in the protocol, we will report these as deviations in 
the Continuing Review. 
 
d. Blinding, including justification for blinding or not blinding the trial, if applicable. 
 
There is no blinding component to the proposed research. 
 
e. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
 
There will be no anticipated disruption to any ongoing treatment or routine care. 
 
f. Justification for inclusion of a placebo or non-treatment group. 
 
There will be no anticipated placebo or non-treatment group. These are pilot or preliminary data that may 
support a future randomized trial which would have a separate IRB approval. 
 
g. Definition of treatment failure or participant removal criteria. 
 
Participants who are not eligible or who are noncompliant with study tasks will be removed from the study 
early. There are no other early stopping rules in the study. 
 
h. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
The intervention consists solely of the treatment manual and brief instructions provided at the treatment 
televisit, and is not accompanied by any ongoing therapy (Sweeney et al., 2019). All participants who 
complete the treatment televisit will be able to keep their copy of the treatment manual. 
 
5. 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
1. Between 18-75 years old 
2. Reside in the United States 
3. Read, write, and speak English fluently 
4. Able to access a video camera on a smartphone, tablet, or other computer 
5. Able to receive text messages or emails (or both) 
6. Consume greater than or equal to 200 mg caffeine per day in a typical week 
7. Indicate a problem that is caused or worsened by caffeine from among the following options: 
sleep problems, anxiety or nervousness, frequent urination, heartburn or other digestive issues, 
feel dependent on or addicted to caffeine 

 
 
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8. Interested in getting help to gradually reduce or eliminate caffeine consumption as part of a 
research study 
 
Exclusion Criteria 
1. Evidence of significant depressive symptoms assessed via PROMIS-Depression-8a and medical 
history 
2. Evidence of problematic alcohol use assessed via the AUDIT-C and medical/substance use 
history 
3. Evidence of problematic substance use other than alcohol, nicotine, or caffeine assessed via the 
DAST-10 and medical/substance use history 
4. Evidence of a significant psychiatric disorder, presentation of acute psychiatric symptoms, or 
any other mental illness that, in the opinion of the investigators, may complicate participation in 
the study. [Anxiety and sleep disorders are not anticipated to interfere with study participation 
and will not generally be exclusionary] 
5. Any medical condition that, in the opinion of the investigators, may interfere with or preclude 
completion of the study 
 
6. 
Drugs/ Substances/ Devices 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
There are no proposed drugs or devices in the proposed research study. 
 
b. Justification and safety information if FDA approved drugs will be administered for non-FDA 
approved indications or if doses or routes of administration or participant populations are 
changed. 
 
N/A 
 
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered. 
 
N/A 
 
7. 
Study Statistics 
a. Primary outcome variable. 
 
To determine to what extent participants will engage with a remote caffeine reduction intervention for 
caffeine-related problems and find it acceptable (Primary objective), we will calculate the percentage of 
completed assessments for each televisit (Treatment, 7 Week Follow-Up, 14 Week Follow-Up) among 
eligible participants, as well as self-reported agreement with the items on the treatment acceptability survey 
completed at the 7 Week Follow-Up televisit (e.g., “I read all or most of the Guide to Caffeine Reduction 
and Cessation,” “Overall, the guide was helpful during my attempt to reduce or quit caffeine.”) 
 
b. Secondary outcome variables. 
 
To determine to what extent participants are successfully able to reduce their caffeine consumption 
following the remote intervention (Secondary objective (a)), we will assess caffeine consumption as 
determined by the caffeine surveys at 7-and 14-week post-treatment follow-ups and compare this with 
consumption at the screening and treatment televisits. 
 

 
 
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To determine to what extent participants report improvement in common caffeine-related problems (e.g., 
insomnia, anxiety, gastrointestinal distress) following the remote intervention (Secondary objective (b)),we 
will assess caffeine related problems, anxiety, sleep problems, and gastrointestinal distress via standardized 
measures (see Table 1) at 7 and 14 weeks post treatment follow-ups and compare this with scores on these 
assessments at the screening and treatment televisits. 
 
To determine whether participants randomized to the immediate intervention group show greater caffeine 
reductions or greater improvements in caffeine-related problems (Secondary objective (c)) at the 7-week 
follow-up relative to the delayed treatment group over the same time-period, we will compare all of the 
secondary outcome variables described above between the two treatment groups to compare our 
intervention relative to spontaneous reduction that may occur with the passage of time. 
 
c. Statistical plan including sample size justification and interim data analysis. 
 
Because the primary purpose of this study is to collect pilot and feasibility data rather than determine 
efficacy via randomized controlled trial, the statistical analysis will be primarily descriptive. Primary 
outcomes will be reported as the proportion of completed televisits among eligible participants as well as 
the mean and standard deviation agreement (visual analog scale) with items on the treatment acceptability 
survey. With respect to secondary outcomes, means and standard deviations for the standardized 
assessments in Table 1 will be calculated for screening, treatment, 7 Week Follow-Up and 14-Week 
Follow-Up visits, and we will also visually inspect individual subject data. With respect to comparisons 
between the immediate and delayed intervention group, we will use a mixed effects regression model with 
between-subjects factors of group, a within subjects factor of time, and a group x time interaction term. A 
power analysis indicates that with two groups, four measurements, an alpha of .05, a desired power of .95, 
correlation among repeated measures of .5, and conservatively estimating a small effect (e.g., partial eta 
squared = .02), a sample size of 100 will be sufficient to detect a treatment effect. Further, we will calculate 
Cohen’s d and partial eta squared effect sizes using means and standard deviations for pre-and post-
treatment for all secondary outcomes. These effect size calculations will be used to determine the necessary 
sample size for any future large-scale randomized controlled trials to assess clinical effects in different 
treatment populations. The desired sample size of 100 is also based on our laboratory’s proven participant 
capacity for prior randomized clinical trials and long-term human laboratory studies (e.g., Evatt et al., 
2016; Sweeney et al., 2017, Sweeney et al., 2019). 
 
d. Early stopping rules. 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
Risks of the study procedures: The procedures employed in this study are benign. There are also no specific 
risks related to the questionnaire assessments. It is possible that interview questions pertaining to 
psychological health or other medical history could cause participants to feel uncomfortable. Participants 
may feel tired, bored or annoyed when responding to surveys. Heavier caffeine users may experience 
unpleasant withdrawal symptoms when reducing caffeine consumption, though the gradual reduction over a 
period of weeks was specifically designed to reduce the frequency and severity of withdrawal. Common 
withdrawal symptoms include headache, tiredness/fatigue, decreased energy/activeness, decreased 
alertness/attentiveness, drowsiness/sleepiness, decreased contentedness/well-being, depressed mood, 
difficulty concentrating, irritability, muzzy/foggy/not clearheaded, muscle pain/stiffness, flu-like 
symptoms, or nausea and/or vomiting (Juliano & Griffiths, 2004). Caffeine withdrawal is a transient 
phenomenon with little medical risk. There is no evidence to suggest caffeine reduction is contraindicated 
to pregnancy (and in fact caffeine reduction may be beneficial for pregnant women; Chen et al., 2016). 

 
 
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Thus, pregnant women, breastfeeding women, or women who are not using an effective means of birth 
control may be included in the study sample. 
 
Risks of a breach in confidentiality: Although we make every attempt to keep participant information and 
data private and stored in a secure place, there is always a risk that sensitive participant information might 
be accidentally disclosed to someone outside of the research project.  
 
b. Steps taken to minimize the risks. 
 
Protection against risks of the study procedures: All participants in this study will be thoroughly informed 
of the potential risks, including of caffeine withdrawal, during the oral informed consent process. Because 
participation is voluntary, participants can withdraw at any time if they find the behavioral procedures or 
caffeine withdrawal effects undesirable. The gradual reduction over a period of weeks was specifically 
designed to reduce the frequency and severity of caffeine withdrawal. The study team carefully reviews 
medical and social history information from Screening to determine eligibility, and a member of the 
Behavioral Pharmacology Research Unit (BPRU) medical staff will be consulted if there are medical 
concerns judged to potentially impact participation. 
 
Protection against risk of a breach in confidentiality: Research staff are highly trained to maintain 
participant confidentiality. Records and data are maintained on encrypted staff computers and HIPAA-
compliant JHMI-credentialed Qualtrics surveys and will only be released outside of the study team with 
written authorization. Study IDs are used on data collection instruments and in electronic data storage 
wherever possible in place of any personally identifying information. The identity of subjects is not 
revealed in written records and documents with subjects’ names are shredded before disposal. Televisits 
will only be arranged via password-protected Zoom meetings with study staff created in the JHMI HIPAA-
compliant instance, or through other approved Johns Hopkins Telemedicine Services (e.g., Polycom) in the 
event of technical or other issues with Zoom. No recordings will be made of participant interactions. 
Regarding the observer ratings, participants are informed when they identify a community observer of the 
questions the observer will answer, and that none of the participant’s other study information will be shared 
with the observer and that the observer ratings will not be shared with the participant. Staff have clear 
instructions to limit the information shared between participant and observer to only that described in the 
consent form and specified study measures. 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
All unanticipated problems and adverse events will be reported to the IRB and other relevant agencies as 
required and described in the Data and Safety Monitoring Plan. 
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
There is a theoretical risk that a breach in confidentiality will occur. In order to protect against this risk, 
research staff are trained in procedures for protecting participant privacy and personal health information. 
Data are managed to maximally protect participant confidentiality (e.g., in locked rooms, on encrypted 
computers, using participant ID codes rather than personal information). Records and data are maintained 
on encrypted computers and will only be released outside of the study team with written authorization from 
the participant. The identity of subjects is not revealed in written records and documents with subjects’ 
names are shredded before disposal. 
 
e. Financial risks to the participants. 
 
There are no financial risks to the participants in this study. 

 
 
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9. 
Benefits 
a. 
Description of the probable benefits for the participant and for society. 
 
Participants in the proposed study may gain insights into their personal use of caffeine and how caffeine 
affects them. They may also gain insight into whether caffeine may cause or exacerbate any problems for 
them such as anxiety, insomnia, or gastrointestinal distress. The participants may find the facts and 
information about caffeine contained in the treatment manual interesting. If the intervention effects from 
our prior studies generalize to remote intervention, participants who have difficulty cutting down their 
caffeine consumption on their own may be able to cut down more effectively with the treatment manual. 
 
The knowledge to be gained from the proposed study is important because it will demonstrate whether our 
previously time- and cost-effective brief intervention for caffeine reduction is feasible and acceptable to 
implement remotely. If this remote intervention is acceptable and feasible, it could be widely disseminable 
and its efficacy can be tested in larger trials. Although only a secondary outcome, the proposed pilot data 
may also demonstrate whether the intervention leads to successful caffeine reduction and successful 
reduction in caffeine-related problems in some individuals. The manual-only treatment is designed to be 
very brief such that health care providers with little experience related to caffeine dependence or behavioral 
interventions could implement the gradual reduction program, and such a widely disseminable treatment 
could have major impact. 
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, proposed bonus, 
and any proposed reductions or penalties for not completing the protocol. 
 
Participants will not be paid for completing the preliminary screening. Participants will be paid $20 for the 
screening televisit, regardless of whether they qualify for subsequent visits. Qualified participants will be 
paid $20 for the treatment televisit, $20 for the Week 7 Follow-Up visit, $20 for the Week 14 Follow-Up 
visit, and will be paid $5 once per week for completing six surveys over six weeks. Participants who 
complete all of their study televisits will receive a $50 completion bonus, thus total compensation is 
anticipated to be $160 for completed participants. If additional televisits or surveys are necessary, such as 
in the event of survey or computer error, participants would be paid at the same per-session rate (i.e., $20 
per televisit and $5 per survey). Compensation will be provided to participants via gift cards (deliverable 
via postal mail or email), or through creation of the participant as a vendor in the JHU system, where the 
participant can request a paper check or direct deposit. The payment strategy will depend on the most 
feasible option available to the study team and/or participant preference. If a participant discontinues 
caffeine reduction, such as due to adverse effects of caffeine withdrawal, they can still complete study 
assessments and receive payment and completion bonuses. If participants are withdrawn due to non-
compliance or are lost to follow-up they will not receive the completion bonus. Similar to our past research, 
community observers will not be paid. 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and identify 
who will pay for them. 
 
There are no costs to participants, although internet/email/video access is an eligibility requirement for 
participation in the study and the study team will not provide access to the internet or videocamera. The use 
of zoom or other telemedicine options will be free to participants. All other study costs will be paid for by 
the research project, which is funded by NIH grant R01DA003890. 
 
 
 

 
 
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