Clinical trial NCT04885166: Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention
Official title: Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prescription Drug Abuse (Not Dependent)
Intentional Misuse
Keywords: diversion
Lead sponsor: Trinity College
Sponsor class: OTHER
Collaborators: name: Texas State University
name: University of Wyoming
First posted: 2021-05-13
Enrollment: 249
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Change in frequency of prescription stimulant diversion
timeFrame: baseline, 3-months, 6-months
measure: Change in intention to divert prescription stimulant medication
timeFrame: baseline, 3-months, 6-months
measure: Change in frequency of prescription stimulant medication misuse
timeFrame: baseline, 3-months, 6-months
measure: User satisfaction with the simulation/placebo
timeFrame: baseline (immediately after simulation or placebo presentation)
measure: Usability of the simulation/placebo
timeFrame: baseline (immediately after simulation or placebo presentation)
measure: 1 month booster engagement
timeFrame: 1 month
measure: 2 month booster engagement
timeFrame: 2 months
Secondary outcomes:
measure: Change in self-efficacy to resist prescription stimulant diversion
timeFrame: baseline, 3-months, 6-months
measure: Resistance strategy use
timeFrame: 3- and 6-months
measure: Change in perceived behavioral norms
timeFrame: baseline, 3-months, 6-months
measure: Change in risk perception
timeFrame: baseline, 3-months
measure: Change in communication with prescriber
timeFrame: baseline, 3-months, 6-months
Other outcomes:
measure: Other substance use
timeFrame: baseline, 3-months, 6-months
measure: Conduct problems
timeFrame: baseline
measure: Change in Attention-Deficit/Hyperactivity Disorder-related impairment
timeFrame: baseline, 6-months
measure: Accidental injuries
timeFrame: 6-months
Locations:
city: Hartford
country: United States
facility: Trinity College
state: Connecticut
city: San Marcos
country: United States
facility: Texas State University
state: Texas
city: Laramie
country: United States
facility: University of Wyoming
state: Wyoming
Study officials:
References: