Prescription Drug Abuse (Not Dependent)NCT04885166
Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention
A study testing Web-based simulation active intervention in people with Prescription Drug Abuse (Not Dependent) and Intentional Misuse, run by Trinity College at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Prescription Drug Abuse (Not Dependent), Intentional Misuse
- What is being tested?
- Web-based simulation active intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 May 2021to 21 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- None.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Trinity College
Hartford, Connecticut, 06106
University of Wyoming
Laramie, Wyoming, 82071
Texas State University
San Marcos, Texas, 78666
About this study
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.
- Being tested
- Web-based placebo presentation, Web-based simulation active intervention
- Keywords
- diversion
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based placebo presentationOther
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.
Web-based simulation active interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based simulation intervention | Experimental | 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. Receives: Behavioral: Web-based simulation active intervention |
| Placebo condition | Placebo comparator | 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. Receives: Other: Web-based placebo presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Prescription Stimulant Diversion
participants will note how many times they have engaged in diversion (i.e., giving away, selling, or trading one's prescribed medication)
Measured: baseline, 3-months, 6-months
Intention to Divert Prescription Stimulant Medication
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).
Measured: baseline, 3-months, 6-months
Frequency of Prescription Stimulant Medication Misuse
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?
Measured: baseline, 3-months, 6-months
User Satisfaction With the Simulation/Placebo
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.
Measured: baseline (immediately after simulation or placebo presentation)
Usability of the Simulation/Placebo
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.
Measured: baseline (immediately after simulation or placebo presentation)
1 Month Booster Engagement
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.
Measured: 1 month
2 Month Booster Engagement
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.
Measured: 2 months
Secondary outcomes (6)
Self-efficacy to Resist Prescription Stimulant Diversion
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.
Measured: baseline, 3-months, 6-months
Resistance Strategy Use
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.
Measured: 3- and 6-months
Perceived Behavioral Norms for Prescription Stimulant Diversion
Participants will indicate, on a scale from 0-100, the percentage of students they believe give away, sell, or trade their prescribed stimulant medication.
Measured: baseline, 3-months
Perceived Behavioral Norms for Prescription Stimulant Misuse
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.
Measured: baseline, 3-months
Perceived Risks From Prescription Stimulant Diversion and Misuse
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).
Measured: baseline, 3-months
Communication With Prescriber
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)
Measured: baseline, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start4 May 2021
- Primary completion21 May 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prescription Drug Abuse (Not Dependent)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Texas State University, University of Wyoming
- Responsible party
- Principal investigator, Laura Holt, Trinity College
- Investigators
- Laura J Holt, PhD, Principal investigator, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885166
- Sponsor's protocol ID
- 1R34DA048345-01A1
- Status last verified
- Feb 2026
- First submitted
- 4 May 2021
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holt LJ, Looby A, Schepis TS. 'Sorry, I don't give away my medication': an examination of refusals todivert stimulant medication. Addict Res Theory. 2026;34(2):233-244. doi: 10.1080/16066359.2025.2560899. Epub 2025 Sep 22.
PubMed 42222344Holt 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.
PubMed 41467299Holt 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.
PubMed 41213561
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention
- ClinicalTrials.gov ID
- NCT04885166
- Acronym / sponsor ID
- 1R34DA048345-01A1
- Keywords
- diversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Trinity CollegeUniversity, hospital or other
- Collaborators
- Texas State University, University of Wyoming
- Study start
- 4 May 2021 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based simulation intervention | Experimental | Behavioral: Web-based simulation active interventionParticipants 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. |
| Placebo condition | Placebo comparator | Other: Web-based placebo presentationParticipants 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. |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based placebo presentationThis 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. | Other | Placebo condition |
| Web-based simulation active interventionThis 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. | Behavioural | Web-based simulation intervention |
Primary outcome
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)
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).
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?
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.
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.
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.
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.
6 secondary outcomes
Self-efficacy to Resist Prescription Stimulant Diversion
Time frame: baseline, 3-months, 6-months
Resistance Strategy Use
Time frame: 3- and 6-months
Perceived Behavioral Norms for Prescription Stimulant Diversion
Time frame: baseline, 3-months
Perceived Behavioral Norms for Prescription Stimulant Misuse
Time frame: baseline, 3-months
Perceived Risks From Prescription Stimulant Diversion and Misuse
Time frame: baseline, 3-months
Communication With Prescriber
Time frame: baseline, 3-months, 6-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42222344Holt LJ, Looby A, Schepis TS. 'Sorry, I don't give away my medication': an examination of refusals todivert stimulant medication. Addict Res Theory. 2026;34(2):233-244. doi: 10.1080/16066359.2025.2560899. Epub 2025 Sep 22.
- Derived from this study: PubMed 41467299Holt 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.
- Derived from this study: PubMed 41213561Holt 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura J Holt, PhD principal investigator
Trinity College
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based simulation active intervention in people with Prescription Drug Abuse (Not Dependent) and Intentional Misuse, run by Trinity College at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Prescription Stimulant Diversion (time frame: baseline, 3-months, 6-months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885166, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.