- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885166
Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention
March 18, 2026 updated by: Laura Holt, Trinity College
Half or nearly half of college students with prescriptions divert their stimulant medication, and a similarly high percentage misuse their medication or use someone else's prescription.
Diversion may lead students to go without needed medication to mitigate their symptoms, increasing their risk for unintentional injuries and substance use.
Further, diversion perpetuates the non-medical use of prescription stimulants (NMUPS), which has become increasingly common among college students.
Diversion also perpetuates medical misuse of stimulants among students with prescriptions, which is associated with poorer attention-deficit/hyperactivity disorder (AD/HD) symptom management and may increase the risk for addictive disorders.
There are no evidence-based interventions targeting diversion of stimulants in college students.
Being approached for one's medication is a key risk factor for diversion, as is medication non-adherence and believing NMUPS and diversion are more prevalent than they are.
Accordingly, in this multi-site study, the investigators will conduct a randomized, controlled trial of 300 college-attending adults with current stimulant prescriptions to examine the preliminary efficacy and feasibility of a single-session, computer-based simulation intervention (with two booster sessions) to prevent prescription stimulant diversion and medication misuse and compare it to a placebo condition.
The intervention, which is grounded in social learning theory and the theory of planned behavior uniquely engages students in interactive discussions with virtual humans to (a) learn about the actual prevalence of NMUPS and diversion and their related risks, (b) practice using refusal strategies when approached for their medication in high-risk situations, and (c) understand how to effectively communicate with prescribers and avoid medication misuse.
The primary aims are to determine if the intervention reduces diversion, intentions to divert, and medication misuse, and to assess user satisfaction with the intervention.
The secondary aims are to examine change in potential mechanisms of action targeted in the intervention, such as self-efficacy to resist diversion, knowledge about diversion and NMUPS, use of behavioral strategies to resist requests for one's medication, and prescriber communication.
If effective, the intervention could be readily and widely disseminated to college counseling centers, psychiatrists, pediatricians, and other prescribers.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
249
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Trinity College
-
-
Texas
-
San Marcos, Texas, United States, 78666
- Texas State University
-
-
Wyoming
-
Laramie, Wyoming, United States, 82071
- University of Wyoming
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 25 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Undergraduate or graduate student at Trinity College (CT); University of Wyoming; Texas State University.
- Will be enrolled at Trinity College (CT); University of Wyoming; Texas State University 6-months from their baseline study session.
- Have a recent (within the past 3 months) prescription for a stimulant medication
- Between the ages of 17 and 25.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-based simulation intervention
Participants in this condition will receive psychoeducation about stimulant medication diversion, stimulant medication misuse, and will practice navigating and resisting requests for their medication with a virtual human.
|
This intervention engages students in interactive discussions with virtual humans to (a) learn about the actual prevalence of NMUPS and diversion and their related risks, (b) practice using refusal strategies when approached for their medication in high-risk situations, and (c) understand how to effectively communicate with prescribers and avoid medication misuse.
|
|
Placebo Comparator: Placebo condition
Participants in this condition will learn about psychological conditions that affect college students most often (e.g., depression), causes of those conditions, and pharmacological/behavioral treatments for those conditions.
|
This presentation will discuss the prevalence of psychological disorders in college students, their etiologies, psychiatric medications, and students' personal experiences navigating college with a diagnosis of an anxiety and learning disorder, respectively.
Attention-deficit/hyperactivity disorder and stimulant medications will be addressed, but diversion and medication misuse will not be discussed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Prescription Stimulant Diversion
Time Frame: baseline, 3-months, 6-months
|
participants will note how many times they have engaged in diversion (i.e., giving away, selling, or trading one's prescribed medication)
|
baseline, 3-months, 6-months
|
|
Intention to Divert Prescription Stimulant Medication
Time Frame: baseline, 3-months, 6-months
|
Intentions to divert stimulant medication were assessed with two questions from the Behavior, Expectancies, Attitudes and College Health Questionnaire (Bavarian et al., 2013) adapted to address diversion: "How likely is it that you will give away, [or sell, trade] your stimulant medication in the next three months?".
These questions had a four-point response scale (1=very unlikely, 4=very likely).
Responses were summed and ranged from 2-8, with 8 indicating the greatest intention to divert (worse outcome).
|
baseline, 3-months, 6-months
|
|
Frequency of Prescription Stimulant Medication Misuse
Time Frame: baseline, 3-months, 6-months
|
participants will indicate any instances of (a) using alternative routes of administration, (b) taking more than your recommended dose, (c) taking someone else's stimulant medication, (d) taking your stimulant with other drugs in order to experience intoxicating effects, or (e) intentionally getting high on your prescribed stimulant medication?
|
baseline, 3-months, 6-months
|
|
User Satisfaction With the Simulation/Placebo
Time Frame: baseline (immediately after simulation or placebo presentation)
|
We will assess the usefulness, information quality, and interface quality of the simulation using the 13-item Post-Study System Usability Questionnaire.
A mean score of 1 indicates lowest level of satisfaction, while a mean score of 7 would indicate the highest level of satisfaction.
|
baseline (immediately after simulation or placebo presentation)
|
|
Usability of the Simulation/Placebo
Time Frame: baseline (immediately after simulation or placebo presentation)
|
Participants will respond to 15 items related to the perceived usefulness, user control, and impact of the simulation/placebo.
A mean score of 1 would indicate the lowest level of perceived usability; a mean score of 5 would indicate the highest rating of usability.
|
baseline (immediately after simulation or placebo presentation)
|
|
1 Month Booster Engagement
Time Frame: 1 month
|
Booster session #1 is delivered via a slide deck and reviews the key points from the slideshow they viewed at the beginning of the study.
Then, participants have to answer 5 questions related to the content.
We assess engagement in the online booster session #1 on a 0-5 scale by summing the number of correct answers to the five comprehension questions embedded in the online booster.
Each correct item receives one point.
Scores ranged from 0 to 5, with 5 indicating the most engagement and accurate understanding of the content.
|
1 month
|
|
2 Month Booster Engagement
Time Frame: 2 months
|
Booster session #2 is delivered via a slide deck and reviews the key points from the slideshow they viewed at the beginning of the study.
Then, participants have to answer 5 questions related to the content.
We assess engagement in the online booster session #2 on a 0-5 scale by summing the number of correct answers to the five comprehension questions embedded in the online booster.
Each correct item receives one point.
Scores ranged from 0 to 5, with 5 indicating the most engagement and accurate understanding of the content.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy to Resist Prescription Stimulant Diversion
Time Frame: baseline, 3-months, 6-months
|
Participants will rate their confidence to (1) resist giving away their medication, (2) resist selling their medication.
These responses, each given on a 5-point scale, were summed and scores ranged from 2 to 10, with 10 indicating the highest level of self-efficacy.
|
baseline, 3-months, 6-months
|
|
Resistance Strategy Use
Time Frame: 3- and 6-months
|
At the 3- and 6-month follow up, participants were asked to describe, through an open-ended response, how they responded if they were approached to give away, sell, or trade their medication since the last assessment.
The data provided below is the count of participants who provided an open-ended response.
|
3- and 6-months
|
|
Perceived Behavioral Norms for Prescription Stimulant Diversion
Time Frame: baseline, 3-months
|
Participants will indicate, on a scale from 0-100, the percentage of students they believe give away, sell, or trade their prescribed stimulant medication.
|
baseline, 3-months
|
|
Perceived Behavioral Norms for Prescription Stimulant Misuse
Time Frame: baseline, 3-months
|
Participants will indicate, on a scale from 0-100, the percentage of students they believe use stimulant medication in a way it was not prescribed.
|
baseline, 3-months
|
|
Perceived Risks From Prescription Stimulant Diversion and Misuse
Time Frame: baseline, 3-months
|
We will assess perceived legal risks associated with prescription stimulant diversion.
We will assess perceived harm from non-medical prescription stimulant use and medical misuse by asking: "How much do people risk harming themselves (physically or in other ways) if they "take stimulants non-medically?" or "use their prescription in a way a prescriber did not intend?
Scores ranged from 5 to 20, with higher scores indicating greater perceived risk (better outcome).
|
baseline, 3-months
|
|
Communication With Prescriber
Time Frame: baseline, 3-months, 6-months
|
Number of times participants communicated with their prescriber regarding their adherence to their prescription and any concerns they have regarding the dose, frequency of administration, and/or side effects in past 90 days.
Responses ranged from 0 to 8, with higher scores denoting more communication with a prescriber (better outcome).
(Investigator-generated scale)
|
baseline, 3-months, 6-months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accidental Injuries
Time Frame: 6-months
|
Participants will note whether they experienced any accidental injuries in the prior 6 months (e.g., car accidents, burns, etc.).
|
6-months
|
|
Other Substance Use
Time Frame: baseline, 3-months, 6-months
|
Participants will report any occasions of marijuana, cocaine, heroin, methamphetamine, or hallucinogen use, or other prescription drug misuse in the previous 90 days.
|
baseline, 3-months, 6-months
|
|
Attention-Deficit/Hyperactivity Disorder-related Impairment
Time Frame: baseline, 3-months, 6-months
|
Using the Impairment Rating Scale, participants reported on the extent to which they experienced problems in social, academic, familial, and vocational circumstances.
Responses options ranged from 1=not at all to 7=extreme problem and were averaged to yield an overall impairment score (Range 1-6.25).
A lower score indicates less impairment (better outcome), whereas a higher score indicates more impairment (poorer outcome).
|
baseline, 3-months, 6-months
|
|
Conduct Problems
Time Frame: baseline
|
Participants reported on the frequency with which they engaged in 11 problem behaviors before age 18 (0=never, 1=once, 2=twice, 3=three times, 4=more than three times).
This scale was adapted from Johnson (1995).
Consistent with Garnier (2008), we counted less severe items (e.g., lied, broke rules) as a "1" when rated at least a four.
More severe items (e.g., hurt another physically, used a weapon, set a fire) had to occur >2 times to be counted towards the total score.
The minimum score was a 0, the maximum an 11.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura J Holt, PhD, Trinity College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Holt LJ, Looby A, Feinn R, Schepis TS. Preventing Prescription Stimulant Diversion and Misuse via a Web-Based Intervention: A Randomized Controlled Trial. J Atten Disord. 2026 Feb;30(2):265-280. doi: 10.1177/10870547251405545. Epub 2025 Dec 30.
- Holt LJ, Looby A, Schepis TS, Feinn R. Preventing prescription stimulant diversion and misuse through brief intervention: Moderators and secondary outcomes from a randomized controlled trial. Exp Clin Psychopharmacol. 2026 Feb;34(1):61-67. doi: 10.1037/pha0000808. Epub 2025 Nov 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2021
Primary Completion (Actual)
May 21, 2024
Study Completion (Actual)
May 21, 2024
Study Registration Dates
First Submitted
May 4, 2021
First Submitted That Met QC Criteria
May 7, 2021
First Posted (Actual)
May 13, 2021
Study Record Updates
Last Update Posted (Actual)
April 8, 2026
Last Update Submitted That Met QC Criteria
March 18, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34DA048345-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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