Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention
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|ClinicalTrials.gov Identifier: NCT04885166|
Recruitment Status : Recruiting
First Posted : May 13, 2021
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prescription Drug Abuse (Not Dependent) Intentional Misuse||Other: Web-based placebo presentation Behavioral: Web-based simulation active intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Preventing Prescription Stimulant Diversion and Medication Misuse Via a Web-Based Simulation Intervention|
|Actual Study Start Date :||May 4, 2021|
|Estimated Primary Completion Date :||January 31, 2023|
|Estimated Study Completion Date :||July 1, 2023|
Experimental: 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.
Behavioral: 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.
Placebo Comparator: 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.
Other: 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.
- Change in 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)
- Change in intention to divert prescription stimulant medication [ Time Frame: baseline, 3-months, 6-months ]How likely is it that you will give away, sell, or trade your stimulant medication in the next three months?
- Change in 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 less than your recommended dose, (d) taking someone else's stimulant medication, (e) taking your stimulant with other drugs in order to experience intoxicating effects, or (f) intentionally getting high on your prescribed stimulant medication?
- 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.
- 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.
- 1 month booster engagement [ Time Frame: 1 month ]We will determine 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.
- 2 month booster engagement [ Time Frame: 2 months ]We will determine 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.
- Change in 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.
- Resistance strategy use [ Time Frame: 3- and 6-months ]If, since the last assessment, participants indicate they have been approached for their stimulant medication, they will be asked to describe how they responded (gave/sell/traded medication or not) to each request. In cases where they did not divert their medication, they will be asked to indicate (open-ended response) how they turned down the request.
- Change in perceived behavioral norms [ Time Frame: baseline, 3-months, 6-months ]Participants will indicate, on a scale from 0-100, what percent of students, on average, engage in (1) diversion and (2) non-medical prescription stimulant misuse.
- Change in risk perception [ 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?
- Change in 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.
- Other substance use [ Time Frame: baseline, 3-months, 6-months ]Participants will report any occasions of binge drinking, and/or marijuana, cocaine, heroin, methamphetamine, or hallucinogen use, or other prescription drug misuse in the previous 90 days.
- Conduct problems [ Time Frame: baseline ]Participants will report on the frequency with which they engaged in 11 problem behaviors before age 18
- Change in Attention-Deficit/Hyperactivity Disorder-related impairment [ Time Frame: baseline, 6-months ]Participants will report on the extent to which they have experienced problems in social, academic, familial, and vocational circumstances. A positive mean change score will indicate that participants experience an increasing level of impairment over the study period, while a negative mean change score will indicate improvement in impairment.
- 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.).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04885166
|Contact: Laura Holt, PhD||203-623-8470||Laura.Holt@trincoll.edu|
|United States, Connecticut|
|Hartford, Connecticut, United States, 06106|
|Contact: Laura Holt, PhD 203-623-8470 Laura.Holt@trincoll.edu|
|United States, Texas|
|Texas State University||Recruiting|
|San Marcos, Texas, United States, 78666|
|Contact: Ty Schepis, PhD 512-245-6805 email@example.com|
|United States, Wyoming|
|University of Wyoming||Recruiting|
|Laramie, Wyoming, United States, 82071|
|Contact: Alison Looby, PhD 307-314-2314 firstname.lastname@example.org|