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

NCT ID: NCT04885166

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-04
• Study Completion Date: 2024-05-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Web-based simulation active intervention

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Web-based placebo presentation

Intervention Type: 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.

Interventions

Web-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.

Intervention Type: OTHER

Web-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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas State University

OTHER

Sponsor Role: collaborator

University of Wyoming

OTHER

Sponsor Role: collaborator

Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Laura Holt

Associate Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Trinity College

Hartford, Connecticut, United States

Texas State University

San Marcos, Texas, United States

University of Wyoming

Laramie, Wyoming, United States

Countries

United States

Other Identifiers

1R34DA048345-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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