Financial Incentives to Promote Stimulant Abstinence in a Community-Based Syringe Exchange Program
Phase: NA
Conditions: Stimulant Use
Sponsor: University of Vermont

 
 
Financial Incentives to Promote Stimulant Abstinence in a Community-Based 
Syringe Exchange Program 
 
NCT05787847 
August 11, 2025 

Human Subjects Research Protocol 
PROTOCOL SUMMARY
Project Title: Financial Incentives to Promote Stimulant Abstinence in a Community-Based 
Syringe Exchange Program
Protocol Version Date 
(10/10/23)
Principal Investigator:
Tyler G. Erath, Ph.D.; Stephen T. Higgins Ph.D. 
Check the type of the review:
Full convened meeting - The IRBs employ the convened meeting review process for review and approval of studies that are 
more than minimal risk. 
x
Expedited review - The IRBs employ the expedited review process for approval of studies that are determined to be minimal 
risk and only involves activities such as; prospective collection of biological specimens for research purposes by noninvasive 
means (blood collection, salvia, nail clippings), collection of data through noninvasive procedures (ultrasounds, MRI, physical 
sensors) and research on behavior such as perception, cognition, motivation, identity, language and communication. 
PURPOSE AND OBJECTIVES
Purpose:  The importance of the research and the potential knowledge to be gained should be explained in detail.  Give 
background information.
The use of methamphetamine and other psychomotor stimulants is both pervasive and increasing in the 
United States. Between 2015 and 2019, the rate of overdose deaths involving psychomotor stimulants has 
increased 180% (Han et al., 2021). Currently, there are no Food and Drug Administration-approved 
medications for stimulant use disorder (StimUD) available due to small and inconsistent effects observed 
for the medications evaluated to date (Brandt et al., 2021). However, contingency management (CM), an 
empirically support treatment for substance use in which individuals earn positive reinforcers for 
adherence to verifiable behaviors, is a very efficacious strategy in reducing cocaine and methamphetamine 
use for individuals with StimUD (Bentzley, et al 2021; Bolivar et al., 2021). 
To date, the research supporting CM for treatment for individuals with StimUD has been primarily 
conducted in settings where individuals are presenting for treatment.  Recruitment in these studies is 
typically characterized as targeted toward “treatment seeking” individuals.  However, many substance 
users are not interested in treatment, but do see value in harm reduction activities, including syringe 
exchange, and the importance of these services has recently been acknowledged by US health leaders.  In 
addition to an array of harm reduction services, there is evidence that some individuals receiving these 
services will enter treatment if that treatment is offered within the “low barrier” environment of the harm 
reduction facility. However, limited research has been conducted examining interest treatment services in 
syringe exchange programs (McMahan et al., 2020). 
Syringe exchange is one of the most widely implemented harm reduction interventions for individuals who 
use drugs in the US. Individuals who are actively using drugs by injection are encouraged to visit a harm 
reduction site and get a supply of new syringes and be given information and other health services relevant 
for individuals who inject drugs (e.g., hepatitis and HIV testing).  The population of individuals who use 
these services may be using opioids (heroin, prescription opioids, fentanyl) or stimulants 
(cocaine/methamphetamine) or any other drugs by injection.  Participants receive information about 
available treatments for those individuals who desire to reduce/stop their drug use.  In fact, at the Safe 
Recovery program, the site of the proposed project, there is a low barrier buprenorphine program for 
individuals who use opioids and would like to receive buprenorphine but who don’t want to enter a formal 
treatment program.  At present there is no comparable treatment for those individuals who use stimulants.  
This proposed project is a first attempt to explore the interest in CM as a treatment for their stimulant use 
disorder.  
The purpose of this study is to examine the potential utility of a CM intervention for individuals with 
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StimUD who already participate in a low-barrier community-based syringe exchange program. To our 
knowledge, this will be the first study to specifically assess the potential efficacy and acceptability of a 
CM intervention for psychomotor stimulant abstinence among individuals who participate in a syringe 
exchange program. In addition, this study seeks to examine intervention implementation in a natural 
setting with a community-based service provider who will be implementing the intervention within their 
clinic. 
References. Include references to prior human or animal research and references that are relevant to the design and conduct of 
the study.
Bentzley, B. S., Han, S. S., Neuner, S., Humphreys, K., Kampman, K. M., & Halpern, C. H. (2021). 
Comparison of treatments for cocaine use disorder among adults: A systematic review and meta-
analysis. JAMA Network Open, 4(5), e218049-e218049.
Bolívar, H. A., Klemperer, E. M., Coleman, S. R., DeSarno, M., Skelly, J. M., & Higgins, S. T. (2021). 
Contingency management for patients receiving medication for opioid use disorder: a systematic 
review and meta-analysis. JAMA psychiatry, 78(10), 1092-1102. 
https://doi.org/10.1001/jamapsychiatry.2021.1969 
Brandt, L., Chao, T., Comer, S. D., & Levin, F. R. (2021). Pharmacotherapeutic strategies for treating 
cocaine use disorder—what do we have to offer?. Addiction, 116(4), 694-710. 
https://doi.org/10.1111/add.15242  
De Crescenzo, F., Ciabattini, M., D’Alò, G. L., De Giorgi, R., Del Giovane, C., Cassar, C., ... & Cipriani, 
A. (2018). Comparative efficacy and acceptability of psychosocial interventions for individuals 
with cocaine and amphetamine addiction: A systematic review and network meta-analysis. PLoS 
medicine, 15(12), e1002715. https://doi.org/10.1371/journal.pmed.1002715 
Dutra, L., Stathopoulou, G., Basden, S. L., Leyro, T. M., Powers, M. B., & Otto, M. W. (2008). A meta-
analytic review of psychosocial interventions for substance use disorders. The American Journal of 
Psychiatry, 165(2), 179–187. https://doi.org/10.1176/appi.ajp.2007.06111851 
Han, B., Compton, W. M., Jones, C. M., Einstein, E. B., & Volkow, N. D. (2021). Methamphetamine use, 
methamphetamine use disorder, and associated overdose deaths among US adults. JAMA 
Psychiatry, 78(12), 1329-1342. https://doi.org/10.1001/jamapsychiatry.2021.2588 
McMahan, V. M., Kingston, S., Newman, A., Stekler, J. D., Glick, S. N., & Banta-Green, C. J. (2020). 
Interest in reducing methamphetamine and opioid use among syringe services program participants 
in Washington State. Drug and Alcohol Dependence, 216, 108243. 
https://doi.org/10.1016/j.drugalcdep.2020.108243 
Prendergast, M., Podus, D., Finney, J., Greenwell, L., & Roll, J. (2006). Contingency management for 
treatment of substance use disorders: A meta-analysis. Addiction, 101(11), 1546–1560. 
https://doi.org/10.1111/j.1360-0443.2006.01581.x 
Objectives:  Clearly state the primary and secondary objective(s) of the study.
We are proposing to pursue the following three specific aims:
Aim 1: To determine the efficacy and feasibility of a financial incentives intervention for abstinence from 
stimulants among individuals participating in a low barrier, community-based syringe exchange program.
Aim 2: To examine the acceptability of a financial incentives intervention for abstinence from stimulants 
among individuals participating in a low barrier, community-based syringe exchange program.
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Aim 3: To examine the efficacy and feasibility of intervention implementation by staff within a 
community-based syringe exchange program, including barriers and facilitators to effective 
implementation. 
METHODS AND PROCEDURES
Study Design: Describe the research design, including a description of any new methodology and its advantage over existing 
methodologies.
We are proposing a two condition, parallel groups, randomized control pilot study to evaluate the efficacy of a 
financial incentives intervention among individuals who use stimulants and take part in a community-based 
syringe exchange program. The study design will include recruiting service recipients who already participate 
in programs offered by the Safe Recovery at the Howard Center, a syringe exchange program located in 
Burlington, VT (i.e., a convenience sample).The experimental group will have the opportunity to earn 
financial incentives contingent on providing a negative urine sample for stimulants using a point-of-care test, 
which indicates abstinence from stimulant use, in addition to health education on the health risks of stimulant 
use and substance injection. The control group will receive health education on the health risks of stimulants 
use and injection. All participants will participate in their syringe exchange services as usual. We chose the 
health education as the control because participants across both conditions already receive the services 
provided by the syringe exchange program. Moreover, this control condition will help control for a potential 
type of between-groups variability. The treatment condition will last for 12 weeks. The primary outcome 
measure will be point-prevalence stimulant abstinence, which will be determined by percentage of negative 
urine samples for stimulants using a point-of-care test.
Procedures:  Describe all procedures (sequentially) to which human participants will be subjected. Identify all procedures that are 
considered experimental and/or procedures performed exclusively for research purposes. Describe the types, frequency and duration 
of tests, study visits, interviews, questionnaires, etc.
Note: A clinical research protocol may involve interventions that are strictly experimental or it may involve some aspect of research 
(e.g., randomization among standard treatments for collection and analysis of routine clinical data for research purposes). It is 
important for this section to distinguish between interventions that are experimental and/or carried out for research purposes versus 
those procedures that are considered standard therapy. In addition, routine procedures performed solely for research purposes (e.g., 
additional diagnostic/follow-up tests) should be identified.
All study procedures are for research purposes only. This will be an experimental study conducted at Safe 
Recovery at the Howard Center. All study procedures will take place in a private, designated room at Safe 
Recovery. Erin O’Keefe, our co-investigator and collaborator on the project, is the program manager at Safe 
Recovery who has authorized and set aside this room as research space to be used for this study. Individuals 
receiving services at the Howard Center Safe Recovery will be approached for participation by a center staff 
member; this particular staff member’s primary role at the Howard Center is to assist with research. This staff 
member is listed as a study team member in UVMClick, has a UVM netid, and has completed CITI training. 
Potentially eligible participants will be asked when they come in for services if they would like to participate 
in a research study. The research assistant will complete each step in the consent process documentation form 
(listed in the additional materials). Prospective participants who consent to participate in the study will move 
on to the screening procedure next. Participants will also be provided with the “Resources Sheet” at the same 
time as the informed consent. 
Screening
Participants will be recruited primarily from Safe Recovery, a harm reduction facility located at the Howard 
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Center in Burlington, Vermont. Approximately 225 individuals per month attend Safe Recovery to exchange 
used syringes for new syringes.  Staff at Safe Recovery estimate that approximately 25% of these individuals 
use cocaine and/or methamphetamine as the primary drug they inject. Individuals receiving services at Safe 
Recovery will be asked about interest in participation by the center research staff. Potentially eligible 
participants will be asked when they come in for services if they would like to participate in a research study. 
If interested, prospective participants will be invited to complete the intake assessment. 
Intake Assessment
All prospective participants will complete a formal assessment at intake; participants will receive $25 for 
completing the assessment. The screening will take no more than 2 hours. Prior to completing the intake 
assessment, the prospective participant will read through and sign the consent form; the consent form will 
contain information about the intake assessment and its procedures, along with the study procedures. During 
the intake, questionnaires will be completed using pen and paper, then will be uploaded onto the computer and 
into a secure web platform, REDCap. The assessment battery will include questionnaires that assess the 
following six areas: (1) sociodemographic, (2) substance use history, (3) substance use follow-back, (4) 
substance craving, (5) demand for substances, and (6) decision making. The first 3 areas will be assessed using 
the WA state syringe exchange survey and Treatment Effectiveness Assessment. Substance craving will be 
assessed using the three-item craving scale. Demand for substances will be assessed using the simulated 
substance purchase task. Decision making will be assessed using the monetary choice questionnaire. For 
additional detail about each measure, see each respective questionnaire. Participants will receive $25 for their 
time and participation in completing the intake assessment. 
Intervention Conditions
Participants will be randomly assigned to one of two intervention conditions. These sessions will be 
administered by one of the following study team members: Howard Center research assistants, UVM research 
assistants helping with the project, or Drs. Erath and Rawson. 
Health Education Condition. The Health Education condition is based on a previous intervention used as a 
control in a number of other studies (Mooney et al, 2013). Sessions consist of an educational program 
addressing a variety of health, wellness, and lifestyle topics adapted from a previously implemented wellness 
manual. One education topic will be discussed each day. The 12 daily educational topics will include: (1) 
stress relief, (2) nutrition, (3) hepatitis prevention, (4) HIV prevention, (5) sleep hygiene, (6) health screening, 
(7) meditation, (8) home emergencies, (9) healthy relationships, (10) common medical problems of people 
who use drugs, (11) strategies to reduce anxiety, depression and other negative moods, and (12) self-
defense. Participants in this condition will be scheduled for two clinic visits per week for 12 weeks. Thus, the 
health education on the 12 topics listed above will be provided in addition to the services provided to all 
individuals in the Howard Center Safe Recovery program. At one session each week, the individual will meet 
with a study team member listed above who will review a topic handout with the participant.  We anticipate 
these sessions will take approximately 10-15 minutes.
Health Education plus Incentives for Abstinence. Participants in the experimental condition will have the 
opportunity to earn financial incentives for abstaining from stimulant use, in addition to receiving the same 
health education as the control condition. Monitoring of stimulant use will occur through twice-weekly 
urinalysis during the 12 weeks of the intervention. Specimens will be screened for stimulant use using a 10-
panel point-of-care test taken at the center. The financial incentives will be contingent on negative samples for 
stimulants which include cocaine, methamphetamine, and amphetamine. The incentive amount will start at 
$25 and increase for each subsequent stimulant-negative urine sample, up to $65 per sample. Only tests where 
the display indicates negative samples will result in participants earning reinforcement. The incentive amount 
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for the first stimulant-negative sample will be $25. Every subsequent negative sample will increase by $2.50, 
with a maximum amount of $65. Thus, the maximum amount a participant could earn if they provide a 
stimulant-negative sample for the entire 12 weeks is $1,220. A reset will occur if a participant submits a 
stimulant-positive sample or has an un-excused absence. The next time the participant submits a stimulant-
negative sample, the incentive amount will reset to the initial voucher value (i.e., $25). A recovery of the pre-
reset value will occur after the participant provides two consecutive stimulant-negative samples; that is, the 
participant will recover back to their previously earned incentive level instead of restarting the incentive 
escalation process. The implementation of the financial incentives will be completed by the study team 
member overseeing the session (e.g., Safe Recovery staff, UVM RA staff). Based on similar studies using 
financial incentives, we expect participants will earn approximately 40% to 50% of the maximum possible 
earnings (Heil et al. 2008; Higgins et al., 1996, 2020). 
Data Collection 
The primary dependent variable is stimulant-free urine samples; all samples will be assessed using point-of-
care test conducted at the center. Urine specimens will be collected for all participants at least once weekly 
throughout the study. Urine specimens are disposed of following recording of the result, thus, no samples are 
stored. Participants in the health education condition will receive $10 for providing each urine sample (2x per 
week). Urine samples will be collected for participants in the financial incentives condition twice weekly for 
all 12 weeks of the intervention for which they can earn the incentives stated above by providing a negative 
urine sample. Participants in both conditions will also complete the questionnaires for decision making, 
demand for substances, craving, and treatment effectiveness at three additional times after baseline, at weeks 
4, 8, and 12. Data for the questionnaires will be completed using pen and paper, then will be uploaded onto the 
computer and into REDCap. All participants will be compensated $10 per assessment independent of 
substance use status to ensure high compliance.
Delivery of Financial Incentives 
All earned incentives will be provided to participants using a gift card or a PEX debit card, a reloadable debit 
card. The gift cards and PEX debit cards do not require a credit history check, and participants will pay no 
monthly fees for carrying the card. There are no costs for using the gift cards or PEX Debit Cards for instore 
or online shopping. Research staff or Safe Recovery staff will load money onto the participants gift or debit 
card after completion of an activity in which an incentive has been earned (i.e., completion of a urinalysis 
screening; negative urinalysis sample). We are choosing to use gift cards or PEX debit cards because they are 
easy to implement and money can be immediately loaded to the cards, thereby reducing the delay between the 
target behavior and delivery of the incentive, an important variable to maximizing the efficacy of the 
incentive. 
Examining Intervention Acceptability
At the 12-week assessment or shortly thereafter, participants in both the incentives for abstinence condition 
and psychoeducation plus usual care condition will complete a Study Acceptability Questionnaire (SAQ). This 
measure will be administered via pen and paper and will then be uploaded onto the computer into REDCap. 
The questionnaire will ask participants about the ease of use, helpfulness, and convenience of the intervention, 
as well as whether the intervention was fair, fun, and whether they would recommend it. Participants in the 
psychoeducation plus incentives condition will receive additional SAQ questions inquiring about whether they 
liked the incentives for abstinence and whether the incentives were helpful in terms of promoting stimulant 
abstinence.  
Describe required screening procedures performed before enrollment and while on study.
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As noted above, participants will be recruited primarily from Safe Recovery, a harm reduction facility located 
at the Howard Center in Burlington, Vermont. Individuals receiving services at Safe Recovery will be 
approached about participation by the Safe Recovery research staff. Potentially eligible participants will be 
asked when they come in for services if they would like to participate in a research study. If interested, 
prospective participants will be invited to complete the intake assessment. 
For research involving survey, questionnaires, etc.:  Describe the setting and the mode of administering the instrument and the 
provisions for maintaining privacy and confidentiality.  Include the duration, intervals of administration, and overall length of 
participation. 
Not applicable
All efforts will be made to maintain confidentiality. Assessments will be completed in a private room at Safe 
Recovery. Prospective participants who are eligible (i.e., participate in the Howard Center’s syringe exchange 
program) will be approached by a study team member and asked about their potential interest in participating 
in the study. If interested, participants will then be provided with information about the study (via informed 
consent) and the study team member will review all steps on the consent process documentation sheet and 
answer any potential questions. If the participant consents to participate, then they will be asked to complete 
the following questionnaires. At intake, the Washington State syringe exchange health survey will be used to 
assess sociodemographic, substance use history, and substance use follow-back (McMahan et al., 2020). 
Demand for substances will be assessed using the simulated substance purchase task (Murphy et al., 2011). 
Decision making will be assessed using the Monetary Choice Questionnaire (Kirby et al., 1999). Substance 
craving will be assessed using the three-item craving scale (McHugh et al., 2021). The intake assessment will 
take no longer than 120 minutes and will occur once at the intake. 
At weeks 4, 8 and 12 of the intervention, all participants will complete the Monetary Choice Questionnaire, 
three-item craving scale, and demand for substances using the simulated purchase task. Data for the 
questionnaires will be completed using pen and paper, then will be uploaded onto the computer and into 
REDCap. Each assessment will take no longer than 20 minutes. 
All data will be coded by an assigned identification number, with the codes known only by the investigators 
on this project. Names will not be connected with any results. The security of the records will be maintained 
by keeping paper files in a locked file cabinet and by keeping REDcap computer files in password protected 
files. The master copy will be kept in a different locked file cabinet from the coded data. The results of this 
study will eventually be published, but patient confidentiality will be maintained.
TYPES OF PROCEDURES (Please do not use the “other” option unless the procedure is not listed.)
Check all that apply.
x
Survey (mail, telephone, in-
person, on-line)
Blood 
drawing:
Vol.
Over days, 
weeks?
x
Medical exams/history
Type & 
Amt.
Deception *see below
Surgery
x
Collection of Urine and/or Feces
x
Observation
Drug Administration 
HIV Testing
Photographs
Device Use 
Ultrasound (e.g. echocardiogram)
Audio Recording
Exercise
Imaging (e.g. CT scan, DEXA, mammogram, PET scans, 
SPECT)
Video Recording
Diet
Use of Radiation treatment
Interviews in person or by 
phone
Pathology Specimens 
(retrospective)
Use of Radioactive substances (e.g. 
radiolabeled antibodies, drugs or contrasts)
Focus Groups
Genetic Materials (DNA)** see 
below
MRI (for treatment studies)
Review of prospective data
x
Questionnaires
MRI (not for treatment studies)
Review of retrospective data
Diaries
Tissue (obtained for clinical purposes)
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Pregnancy Tests
Tissue (obtained solely for research)
Recording of Identifiable Data
Electrocardiograms
x
Sensitive Data (criminal or sexual conduct, drug or 
alcohol conduct or use)
(specify):
**If genetic information is being collected, GINA language must be added to the consent form.
*Deception typically involves withholding information from the potential subject and would require an alteration to 
the consent process.
Statistical Considerations: Delineate the precise outcomes to be measured and analyzed. Describe how these results will be 
measured and statistically analyzed. Delineate methods used to estimate the required number of subjects. Describe power 
calculations if the study involves comparisons.  Perform this analysis on each of the primary and secondary objectives, if possible.
Participant baseline demographics and characteristics will be compared between treatment conditions (Health 
Education vs. health Education plus Incentives for Abstinence) using Chi Square Tests of Independence or 
Fisher’s Exact Tests for categorical variables and Wilcoxon Rank Sum Tests or Two-Sample T-tests for 
continuous variables, depending on the distributions of the variables. If a specific characteristic differs 
significantly between treatment conditions and is predictive of the outcome, it will be considered as a potential 
covariate in subsequent analyses. The primary outcome to be analyzed will be point-prevalence stimulant 
abstinence, which will be determined by percentage of negative urine samples for stimulants using a point-of-
care test. Analyses of treatment condition effect on point-prevalence stimulant abstinence will adhere to an 
intent-to-treat approach whereby all participants randomized to each treatment condition will be included in 
the analyses independent of early dropout, noncompliance, etc. Point-prevalence abstinence rates will be 
compared between treatment conditions at individual timepoints using Chi Square Tests of Independence. 
Comparisons of point-prevalence abstinence rates between treatment conditions across all assessments will be 
analyzed using mixed model repeated measures for categorical data based on generalized estimating equations 
(GEE) using a logistic link function. Comparisons of predictors of abstinence that are continuous outcomes 
and continuous outcomes based on survey responses between treatment conditions across all assessments will 
be analyzed using mixed model repeated measures analyses of variance. Comparisons of predictors of 
abstinence that are categorical outcomes and categorical outcomes based on survey responses between 
treatment conditions across all assessments will be analyzed using mixed model repeated measures for 
categorical data based on generalized estimating equations (GEE) using a logistic link function. 
     Because this is an exploratory pilot study evaluating the potential efficacy, feasibility, and acceptability of 
a contingency management intervention for stimulant use within a syringe exchange program, we are 
proposing a small, initial pilot study of 40 participants. Data from a previous meta-analysis study (Bolívar et 
al., 2021), which examined the CM treatment effects on abstinence from psychomotor stimulant use found a 
mean effect size for treatment effect on abstinence from psychomotor stimulant of Cohen’s d = 0.70. 
However, among studies included in this analysis, the minimum effect size which was for the outcome of 
point-prevalence stimulant abstinence was Cohen’s d = 0.51 (Rawson et al., 2002; 
doi:10.1001/archpsyc.59.9.817). Using this “medium” effect size for sample size calculation, in order to detect 
a statistically significant difference in point-prevalence stimulant abstinence between treatment conditions 
with 80% power, with 2-sided significance level alpha of 0.05, a total sample size of 88 participants would be 
required. However, because this is an initial pilot study looking to assess feasibility and potential efficacy, we 
expect to observe discernable differences between the two conditions with a sample size of 40. The goal is to 
conduct a pilot study where the data could then be used to inform a larger, fully powered randomized control 
trial. 
Risks/Benefits:  Describe any potential or known risks.  This includes physical, psychological, social, legal or other risks.  Estimate 
the probability that given risk may occur, its severity and potential reversibility.  If the study involves a placebo or washout period, the 
risks related to these must be addressed in both the protocol and consent.  Describe the planned procedures for protecting against or 
minimizing potential risks and assess their likely effectiveness.  Where appropriate, discuss plans for ensuring necessary medical or 
professional intervention in the event of adverse effects to the subjects.   Discuss the potential benefits of the research to the subjects 
and others.  Discuss why the risks to the subjects are reasonable in relation to the anticipated benefits to subjects and others.  
Discuss the importance of the knowledge gained or to be gained as a result of the proposed research and why the risks are 
reasonable in relation to the knowledge that reasonably may result.  If there are no benefits state so.
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Risks
- Prospective participants who consent to participate in the study will be asked questions about their substance 
use, which may be uncomfortable.  This research is covered by a Certificate of Confidentiality (CoC) from the 
National Institutes of Health. This means that the researchers cannot release or use information, documents, or 
samples that may identify participants in any action or suit unless they say it is okay. They also cannot provide 
them as evidence unless the participant has agreed.  This protection includes federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. An example would be a court subpoena. The CoC is 
automatic with NIH funding. 
- Although unlikely, a breach of confidentiality could occur. Signed informed consent forms will be stored 
separately from all collected data in a different locked cabinet in a locked office at the Vermont Center on 
Behavior and Health, which is located in the University of Vermont Medical Center, UHC campus.
- Participants in this study may experience withdrawal. These symptoms can include anger, irritability, 
frustration, anxiousness, depressed mood, substance cravings, difficulty concentrating, sleep problems, 
restlessness, impatience, constipation, dizziness, nightmares, and nausea. If these mood changes appear to put 
a participant’s health at risk, they will be asked to stop participating in the study. We will be providing a 
resources sheet about withdrawal services available to each participant (and other services available) when 
they complete the informed consent. Additional copies will also be available for participants throughout the 
study. 
Benefits
-  The primary benefit is that participation could result in abstinence or reduced use of psychomotor 
stimulants. This would have numerous positive health benefits for the participant. This study may also teach 
us how to more effectively help others stop using stimulants. The other information that participants provide 
may increase knowledge about factors that influence the ability to quit using stimulants.
Therapeutic Alternatives:  List the therapeutic alternatives that are reasonably available that may be of benefit to the potential 
subject and include in the consent form as well.
Not Applicable
Participants could attempt to stop or reduce their stimulant use on their own, without support offered by 
participation in the study. 
Data Safety and Monitoring:  The specific design of a Data and Safety Monitoring Plan (DSMP) for a protocol may vary extensively 
depending on the potential risks, size, and complexity of the research study.  For a minimal risk study, a DSMP could be as simple as 
a description of the Principal Investigator’s plan for monitoring the data and performance of safety reviews or it could be as complex 
as the initiation of an external, independent Data Safety and Monitoring Board (DSMB). The UVM/UVM Medical Center process for 
review of adverse events should be included in the DSMP.
All efforts will be made to maintain confidentiality. The IRB at UVM will review this protocol. Oversight 
of the project and monitoring will be conducted by the primary investigators (Dr. Erath and Dr. Higgins). 
All procedures will be monitored to ensure adherence with the protocol. All assessments will be conducted 
privately. All questionnaires will be administered on paper. A hard copy of the collected data will be stored 
in a locked office within a locked file cabinet. All hard copy questionnaire data does not contain any 
directly identifiable information. Hard copy data will be inputted into, and directly stored on, a secure web 
platform, REDCap. All data will be coded by identification number, with the codes known only by the 
investigators on this project. Names will not be connected with any results. The monitoring plan will 
consist of ongoing, close monitoring of data and safety issues by the PI and other project staff and prompt 
reporting of any adverse events (AEs) or serious adverse events (SAEs) to the institutional review board 
and/or NIGMS. The security of these records will be maintained by keeping paper files in a locked file 
cabinet and by keeping computer files in a password protected file on REDcap. The results of this study 
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will eventually be published, but patient confidentiality will be maintained.
Define criteria to be used for decision making regarding continuation, modification, or termination of the entire study (not individual 
participation) (i.e. “stopping rules).
We plan to continue this study until the sample size has been met, after which the study will be terminated. 
What will be the frequency of the review?  Please note that the frequency of reviews should be commensurate with the risk of 
the study.  At a minimum, a review of the data should be conducted annually at time of continuing review.  Forward copies of the 
data and safety monitoring reports to the 1) IRB, 2) CRC (if applicable), and/or 3) UVMCC (if applicable).
Monthly
x
Annually
Quarterly
Other (e.g. by dosing level, no. of subjects enrolled):
Bi-annually
Will the sponsor be conducting data monitoring visits for this study?
Yes
x
No
NA
If yes, how often?
Adverse Event, Unanticipated Problem (UAP), Reportable New Information (RNI):  Describe how events and UAPs will be 
evaluated and reported to the IRB.  All protocols should specify that, in the absence of more stringent reporting requirements, the 
guidelines established in the “Adverse Event and Unanticipated Problems Reporting Policy” will be followed.  The UVM/UVM Medical 
Center process for review of adverse events and UAPs to subjects or others should be included in the DSMP.
The primary investigators will evaluate all AEs, UAPs, and RNIs. We will follow the guidelines established 
by the Committees on Human Research “Adverse Event and Unanticipated Problems Reporting Policy”.  Any 
SAE will be brought to the attention of the PIs as soon as possible and no longer than 24 hours. Any AE or 
SAE that is both unexpected and related to study participation will be reported to the IRB within 7 days of the 
event. The IRB will make a determination as to whether additional reporting requirements are needed. IRB 
actions will be reported to the funding agency by the PIs no less than annually and more frequently as 
recommended by the local IRB. Any SAEs will be summarized in the yearly Progress Reports to the funding 
agency, including a review of frequency and severity. All SAEs will be followed through ongoing consultation 
with the physician caring for the patient until they resolve, result in death, or stabilize and are not expected to 
improve. The study staff will be in close contact with participants and health care providers throughout the 
study to monitor for potential unanticipated problems. Any unanticipated problems will be discussed at the 
weekly research staff meetings and reported as required to the CHRBSS using the Report of Protocol-Related 
Problems & Deviations Form.
Withdrawal Procedures:  Define the precise criteria for withdrawing subjects from the study.   Include a description of study 
requirements for when a subject withdraws him or herself from the study (if applicable).
Participants are free to withdraw from the study at any time and for any reason while they are completing the 
study. Participants may be withdrawn if the PIs determine it is not advisable that they continue on in the study. 
Regarding data analysis, we will adhere to an intent-to-treat approach (Armitage, 1983) wherein all 
participants randomized to the study conditions will be included in the analyses independent of early dropout, 
or noncompliance. 
Sources of Materials:  Identify sources of research material obtained from individually identifiable human subjects in the form of 
specimens, records or data.  Indicate whether the material or data will be obtained specifically for research purposes or whether use 
will be made of existing specimens, records or data.
CHRBSS (Behavioral) #STUDY00002042 Approved: 10/10/2023 

10
Human subjects protocol form 
IRB form version 11/20/2020
All data collected will be for research purposes only. This study will include individuals 18 years and older 
who participate in services provided by Safe Recovery at the Howard Center in Burlington, VT. The data 
collected will include both answers to the questionnaires described above and urine specimens which will be 
tested for psychomotor stimulants. Thus, the sources of materials include: 
-
Questions on sociodemographic, substance use history, and substance use follow-back 
-
Questions on demand for substances, decision making, and substance craving 
-
Urine samples to be tested for recent stimulant use
DRUG INFORMATION
Investigators are encouraged to consult the UVM Medical Center Investigational Pharmacy Drug Service (847-4863) prior to finalizing 
study drug/substance procedures.
Drug (s)
x
Not applicable
Drug name – generic followed by brand name and common abbreviations. Availability – Source and pharmacology; vial or product 
sizes and supplier.  If a placebo will be used, identify its contents and source. 
Preparation:  Reconstitution instructions; preparation of a sterile product, compounded dosage form; mixing guidelines, including fluid 
and volume required.  Identify who will prepare.
Storage and stability – for both intact and mixed products.
Administration – Describe acceptable routes and methods of administration and any associated risks of administration.
Toxicity – Accurate but concise listings of major toxicities.  Rare toxicities, which may be severe, should be included by indicated 
incidence.  Also, adverse interactions with other drugs used in the protocol regimen as well as specific foods should be noted.  
Address significant drug or drug/food interactions in the consent form as well.  List all with above details.
Is it FDA approved: (include FDA IND Number)
1.  in the dosage form specified?  If no, provide justification for proposed use and source of the study drug in that form.
2.  for the route of administration specified?  If no, provide justification for route and describe the method to accomplish.
3.  for the intended action?
SUBJECT CHARACTERISTICS, 
IDENTIFICATION AND 
RECRUITMENT
Subject Selection:  Provide rationale for subject selection in terms of the scientific objectives and proposed study design.
This study will be comprised of individuals 18 years and older who participate in services provided by Safe 
Recovery at the Howard Center in Burlington, VT. This convenience sample was chosen based on interest 
from the organization to query information about current substance use behavior and potential interest in 
participating in an evidence-based intervention to reduce substance use. 
Vulnerable Populations:  Explain the rationale for involvement of subjects (e.g., cognitively impaired, Non-English speaking, 
prisoners, students).  Discuss what procedures or practices will be used in the protocol to minimize their susceptibility to undue 
influences and unnecessary risk (physical, psychological, etc.).
Not applicable
Individuals who use stimulants and participate in a syringe exchange program, in order to develop more effective interventions to help 
them stop or reduce their stimulant use. 
Inclusion/Exclusion Criteria:  Eligibility and ineligibility criteria should be specific. Describe how eligibility will be determined and by 
whom.  Changes to the eligibility criteria at a later phase of the research have the potential to invalidate the research.
CHRBSS (Behavioral) #STUDY00002042 Approved: 10/10/2023 

11
Human subjects protocol form 
IRB form version 11/20/2020
Study participants will be individuals who participate in the syringe exchange. Participants will be recruited 
from the safe recovery syringe exchange program at the Howard Center – a local, community-based care 
center – in which they already participate. 
To be included in the study, prospective participants must meet the following criteria: (a) be 18 years or older, 
(b) report using stimulants in the past 30 days, and (c) meet the DSM-5 diagnosis for stimulant use disorder at 
a moderate or severe level (i.e., 6 or more of the 11 DSM criteria), and (d) participation in services offered by 
Howard Center Safe Recovery
Exclusionary criteria: (a) failure to meet one or more inclusionary criteria above, (b) individuals who are 
cognitively impaired by their drug use or psychiatric conditions that could preclude informed consent. 
Specifically pertaining to criterion b: individuals who are intoxicated and/or acutely psychotic will be 
precluded from the study. The Howard Center staff will make this assessment based on their training and 
clinical judgement.
Individuals will be formally enrolled in the study if they meet all inclusionary criteria, complete the initial 
intake assessment, and complete the informed consent process.
Inclusion of Minorities and Women:  Describe efforts to include minorities and women.  If either minorities or women are excluded, 
include a justification for the exclusion.
This study will include all individuals who receive services from Safe Recovery at the Howard Center, 
including women and minorities. 
Inclusion of Children: Describe efforts to include children.  Inclusion is required unless a clear and compelling rationale shows that 
inclusion is inappropriate with respect to the health of the subjects or that inclusion is inappropriate for the purpose of the study.  If 
children are included, the description of the plan should include a rationale for selecting or excluding a specific age range of children.  
When included, the plan must also describe the expertise of the investigative team in working with children, the appropriateness of the 
available facilities to accommodate children, and the inclusion of a sufficient number of children to contribute to a meaningful analysis 
relative to the purpose of the study.  Provide target accrual for this population. Identify whether children are wards of the state. If 
children are excluded then provide appropriate justification.
The Safe Recovery Program primarily targets adults. Children are excluded. 
For protocols including the use of an investigational drug, indicate whether women of childbearing potential have been included and, if 
not, include appropriate justification.
There will be no use of an investigational drug. 
If HIV testing is included specifically for research purposes explain how the test results will be protected against unauthorized 
disclosure.  Include if the subjects are to be informed of the test results.  If yes, include the process and provision for counseling.  If 
no, a rationale for not informing the subjects should be included.
x
Not applicable
Will the SONA Psychology Pool be utilized? Include documentation indicating permission to use this 
recruiting tool 
Yes
No
FINANCIAL CONSIDERATIONS 
Describe all potential research related expenses to subjects:  
There are no expenses for participants. 
Compensation for participation:  Describe all plans to pay subjects, either in cash, a gift or gift certificate. Please note that all 
payments must be prorated throughout the life of the study. The IRB will not approve a study where there is only a lump sum 
payment at the end of the study because this can be considered coercive. The amount of payment must be justified. Clarify if 
subjects will be reimbursed for travel or other expenses.
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12
Human subjects protocol form 
IRB form version 11/20/2020
Not applicable
All prospective participants will complete a formal assessment at intake for which they will receive $25 
for completing the assessment. All participants will complete the questionnaires for decision making task 
and demand for substances three additional times after baseline, at weeks 4, 8, and 12, and will be 
compensated $10 per assessment independent of substance use status to ensure high compliance. If 
randomized to Intervention A, participants can earn $10 for providing each urine sample twice per week 
(total up to $240); the incentive is not contingent on a stimulant negative urine sample (i.e., is only 
contingent on providing the sample). Thus, the maximum amount a participant can earn in Intervention A 
is $295. If randomized to Intervention B, urine samples will be collected for participants twice weekly for 
12 weeks where participants can earn incentives by providing a negative urine sample (i.e., the incentive 
is contingent on providing a stimulant negative urine sample). Incentives for these samples start at $25 
and max out at $65 (max total - $1,220). Thus, the maximum amount a participant can earn is $1,275. All 
compensation will be delivered on a gift card or a reloadable debit card. 
Research Data Management Plan: The Research Data Management and Security Plan form must be 
completed. The form, along with guidance, can be found in our forms library and must be submitted with your 
initial application.
CHRBSS (Behavioral) #STUDY00002042 Approved: 10/10/2023