Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention

NCT04885166 | Completed Results DMC

• 1 other identifier: 1R34DA048345-01A1
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Prescription Drug Abuse (Not Dependent); Intentional Misuse

Keywords

diversion

Outcome Measures

Primary Outcomes (7)

• 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)

  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).

  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?

  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.

  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.

  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.

  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.

  2 months

Secondary Outcomes (6)

• Self-efficacy to Resist Prescription Stimulant Diversion

  baseline, 3-months, 6-months

• Resistance Strategy Use

  3- and 6-months

• Perceived Behavioral Norms for Prescription Stimulant Diversion

  baseline, 3-months

• Perceived Behavioral Norms for Prescription Stimulant Misuse

  baseline, 3-months

• Perceived Risks From Prescription Stimulant Diversion and Misuse

  baseline, 3-months

Other Outcomes (4)

• Accidental Injuries

  6-months

• Other Substance Use

  baseline, 3-months, 6-months

• Attention-Deficit/Hyperactivity Disorder-related Impairment

  baseline, 3-months, 6-months

Study Arms (2)

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.

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.

Other: Web-based placebo presentation

Interventions

Web-based placebo presentation OTHER

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.

Placebo condition

Web-based simulation active intervention BEHAVIORAL

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.

Web-based simulation intervention

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Trinity College: lead
• Texas State University: collaborator
• University of Wyoming: collaborator

Study Sites (3)

Trinity College

Hartford, Connecticut, 06106, United States

Location

Texas State University

San Marcos, Texas, 78666, United States

Location

University of Wyoming

Laramie, Wyoming, 82071, United States

Location

Related Publications (2)

• 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.

  PMID: 41467299 DERIVED

• 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.

  PMID: 41213561 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

* We did not achieve target sample of 300, due to lower recruitment at one site and COVID-19 public health emergency * Females were overrepresented in our sample; findings may have limited generalizability to males * Rates of prescription stimulant diversion were low, suggesting our sample was lower risk and may have benefited less from the intervention * Study occurred during prescription stimulant shortage in the US; diversion and misuse may have been less likely as a result.

Results Point of Contact

• Title: Laura Holt
• Organization: Trinity College

Laura.Holt@trincoll.edu

860-297-4019

Study Officials

• Laura J Holt, PhD

  Trinity College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 13, 2021
• Study Start: May 4, 2021
• Primary Completion: May 21, 2024
• Study Completion: May 21, 2024
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)