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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04885166
Enrollment
249
Registered
2021-05-13
Start date
2021-05-04
Completion date
2024-05-21
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intentional Misuse, Prescription Drug Abuse (Not Dependent)

Keywords

diversion

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.

Interventions

OTHERWeb-based placebo presentation

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.

BEHAVIORALWeb-based simulation active intervention

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.

Sponsors

Trinity College
Lead SponsorOTHER
Texas State University
CollaboratorOTHER
University of Wyoming
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
17 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Frequency of Prescription Stimulant Diversionbaseline, 3-months, 6-monthsparticipants 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 Medicationbaseline, 3-months, 6-monthsIntentions 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 Misusebaseline, 3-months, 6-monthsparticipants 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/Placebobaseline (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/Placebobaseline (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 Engagement1 monthBooster 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 Engagement2 monthsBooster 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

MeasureTime frameDescription
Self-efficacy to Resist Prescription Stimulant Diversionbaseline, 3-months, 6-monthsParticipants 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.
Resistance Strategy Use3- and 6-monthsAt 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.
Perceived Behavioral Norms for Prescription Stimulant Diversionbaseline, 3-monthsParticipants will indicate, on a scale from 0-100, the percentage of students they believe give away, sell, or trade their prescribed stimulant medication.
Perceived Behavioral Norms for Prescription Stimulant Misusebaseline, 3-monthsParticipants will indicate, on a scale from 0-100, the percentage of students they believe use stimulant medication in a way it was not prescribed.
Perceived Risks From Prescription Stimulant Diversion and Misusebaseline, 3-monthsWe 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).
Communication With Prescriberbaseline, 3-months, 6-monthsNumber 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)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLaura J Holt, PhD

Trinity College

Baseline characteristics

Characteristic
Age, Continuous20.42 years
STANDARD_DEVIATION 1.8
Attention-Deficit/Hyperactivity Disorder Symptom Severity46.75 units on a scale
STANDARD_DEVIATION 9.05
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
94 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants
Race (NIH/OMB)
Asian
5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
18 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
202 Participants
Region of Enrollment
United States
113 participants
Sex: Female, Male
Female
174 Participants
Sex: Female, Male
Male
24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1220 / 113
other
Total, other adverse events
0 / 1220 / 113
serious
Total, serious adverse events
0 / 1222 / 113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026