Skip to main content
OpenTrials
Completed

NCT Number: NCT04885166

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity College, Hartford, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

  2. 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).

  3. 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?

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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).

  6. 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)

Other outcomes

  1. 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.).

  2. 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.

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Trinity College

Other

Collaborators

  • Texas State University
  • University of Wyoming

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 13, 2021
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.