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

Primary Purpose

Prescription Drug Abuse (Not Dependent), Intentional Misuse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-based placebo presentation
Web-based simulation active intervention
Sponsored by
Trinity College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prescription Drug Abuse (Not Dependent) focused on measuring diversion

Eligibility Criteria

17 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Trinity CollegeRecruiting
  • Texas State UniversityRecruiting
  • University of WyomingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Web-based simulation intervention

Placebo condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in frequency of prescription stimulant diversion
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
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
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
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
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
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
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.

Secondary Outcome Measures

Change in self-efficacy to resist prescription stimulant diversion
Participants will rate their confidence to (1) resist giving away their medication, (2) resist selling their medication.
Resistance strategy use
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
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
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
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.

Full Information

First Posted
May 4, 2021
Last Updated
April 13, 2023
Sponsor
Trinity College
Collaborators
Texas State University, University of Wyoming
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1. Study Identification

Unique Protocol Identification Number
NCT04885166
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trinity College
Collaborators
Texas State University, University of Wyoming

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prescription Drug Abuse (Not Dependent), Intentional Misuse
Keywords
diversion

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Web-based simulation intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo condition
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Web-based placebo presentation
Intervention Description
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
Behavioral
Intervention Name(s)
Web-based simulation active intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in frequency of prescription stimulant diversion
Description
participants will note how many times they have engaged in diversion (i.e., giving away, selling, or trading one's prescribed medication)
Time Frame
baseline, 3-months, 6-months
Title
Change in intention to divert prescription stimulant medication
Description
How likely is it that you will give away, sell, or trade your stimulant medication in the next three months?
Time Frame
baseline, 3-months, 6-months
Title
Change in frequency of prescription stimulant medication misuse
Description
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?
Time Frame
baseline, 3-months, 6-months
Title
User satisfaction with the simulation/placebo
Description
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.
Time Frame
baseline (immediately after simulation or placebo presentation)
Title
Usability of the simulation/placebo
Description
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.
Time Frame
baseline (immediately after simulation or placebo presentation)
Title
1 month booster engagement
Description
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.
Time Frame
1 month
Title
2 month booster engagement
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change in self-efficacy to resist prescription stimulant diversion
Description
Participants will rate their confidence to (1) resist giving away their medication, (2) resist selling their medication.
Time Frame
baseline, 3-months, 6-months
Title
Resistance strategy use
Description
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.
Time Frame
3- and 6-months
Title
Change in perceived behavioral norms
Description
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.
Time Frame
baseline, 3-months, 6-months
Title
Change in risk perception
Description
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?
Time Frame
baseline, 3-months
Title
Change in communication with prescriber
Description
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.
Time Frame
baseline, 3-months, 6-months
Other Pre-specified Outcome Measures:
Title
Other substance use
Description
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.
Time Frame
baseline, 3-months, 6-months
Title
Conduct problems
Description
Participants will report on the frequency with which they engaged in 11 problem behaviors before age 18
Time Frame
baseline
Title
Change in Attention-Deficit/Hyperactivity Disorder-related impairment
Description
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.
Time Frame
baseline, 6-months
Title
Accidental injuries
Description
Participants will note whether they experienced any accidental injuries in the prior 6 months (e.g., car accidents, burns, etc.).
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Holt, PhD
Phone
203-623-8470
Email
Laura.Holt@trincoll.edu
Facility Information:
Facility Name
Trinity College
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Holt, PhD
Phone
203-623-8470
Email
Laura.Holt@trincoll.edu
Facility Name
Texas State University
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ty Schepis, PhD
Phone
512-245-6805
Email
schepis@txstate.edu
Facility Name
University of Wyoming
City
Laramie
State/Province
Wyoming
ZIP/Postal Code
82071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Looby, PhD
Phone
307-314-2314
Email
alooby@uwyo.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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