Clinical trial NCT03037476: Personalized Health Assessment Related to Medications (Project PHARM)
Official title: Personalized Health Assessment Related to Medications (Project PHARM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feedback, Psychological
Clinical Trial
Substance Abuse
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-01-31
Enrollment: 843
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research will adapt an evidence based intervention for alcohol and other drugs and evaluate its efficacy on Prescription Stimulant Medication (PSM) misuse in a web-based format for use with college students who have misused PSMs.

Detailed description: This project proposes to evaluate the efficacy of Screening and Brief Interventions (SBIs) for reducing college students' PSM misuse through two different routes of screening and intervention across 9 colleges and universities spanning the United States. The research will consist of studies designed to 1) conduct focus groups to refine feedback materials (Study 1); 2) Conduct screening through the Registrar's student lists and implement a randomized controlled trial (RCT) of a web-based PSM intervention at all sites (Study 2); and 3) Evaluate the impact of the COVID-19 pandemic using the Study 2 sample on non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months.

Study 1 consists of conducting up to 5 focus groups of 8-12 people to elicit feedback regarding the Personalized Feedback Tool and make refinements prior to carrying out Study 2.

In Study 2, students from 9 college campuses are screened for past year PSM misuse. Those meeting study criteria are invited to complete a web-based baseline survey and are randomized to either receive the web-based personalized feedback intervention (PFI) or to assessment only control. Participants complete follow-up assessments at 6 and 12 months post-baseline to evaluate intervention efficacy. The investigators hypothesize that participants who receive the PFI will reduce PSM misuse assessed at 6 and 12 month follow-ups. The investigators further expect reductions in perceived benefits of PSM and perceived descriptive norms for PSM, and increases in use of alternative behaviors to support academic success, and expect these changes will mediate impacts on PSM use at follow-ups. Secondary effects of the intervention on alcohol and marijuana use are also anticipated, and these reductions are expected to partially mediate PSM outcomes. Finally, PSM motives and demographics as potential moderators of intervention efficacy will also be explored.

Lastly, in February of 2021, we received approval to modify the aims for Study 3 to evaluate the impact of the COVID-19 pandemic using the Study 2 sample. In an already consented, recruited, and well-characterized sample of high-risk young adults reporting poly-substance use (Study 2 participants, n=843), Study 3 aimed to describe changes in non-medical use of prescription stimulants, prescription opiates, alcohol use, marijuana use, and other substances during the COVID-19 pandemic, and understand motives, access, mental health impacts, and college student and young adult experiences during this unprecedented 12 months. Specifically, we intend to evaluate changes pre- and post-pandemic in non-medical use of PSM, non-medical use of prescription opioid medications (POM), alcohol use, and marijuana use, as well as mood utilizing Study 2 baseline and follow-up data, controlling for intervention condition and time since last assessment. We also will evaluate student status and living arrangement as moderators. The investigators hypothesize: (1) Young adults will report less PSM and less POM during the pandemic compared to pre-pandemic assessments, in part due to reduced ease of access and a change in motives for use; (2) Given previous findings that academic motives were 8 of the 9 most frequently endorsed reasons for PSM, and given perceptions that a move to virtual learning has been less academically challenging, we hypothesize that academic motives for PSM will decrease significantly during the pandemic compared to pre-pandemic; (3) Those no longer in school will report less PSM and less POM during the pandemic compared to pre-pandemic. (4) Those living at home will have decreased alcohol and marijuana use compared to pre-pandemic. Among those reporting current student status at the time of the new survey, we will be able to evaluate changes in motives for use, access, and academic pressure from baseline to present.

Eligibility criteria: Study 1 Inclusion Criteria:

* Provides consent to participate
* Currently enrolled as a student at one of the participating campuses
* Between 18-25 year olds
* Misuse of prescription stimulants in the past year

Study 1 Exclusion Criteria:

* There are no exclusion criteria other than not meeting inclusion criteria.

Study 2 Inclusion Criteria:

* Provides consent to participate
* Currently enrolled as a student at one of the participating campuses and in their second semester/quarter or later
* Has an anticipated graduation date at least 12 months into the future
* Between 18-25 year olds
* Misuse of prescription stimulants in the past year

Study 2 Exclusion Criteria:

* There are no exclusion criteria other than not meeting inclusion criteria.

Study 3 Inclusion Criteria:

* Provides consent to participate
* Previous participation as a Study 2 participant.

Study 3 Exclusion Criteria:

* There are no exclusion criteria other than not meeting inclusion criteria.

Primary outcomes:
measure: Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Past 6 Month Medical Misuse of Prescription Stimulant Medication
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire
timeFrame: 6 and 12 month follow-up
Secondary outcomes:
measure: Change in Peak Quantity of Alcohol Consumed in Past Month
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Past 6 Month Daily Drinking Questionnaire
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Past 6 Month Rutgers Alcohol Problem Index
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Past Year, 6 Month, and 30 Day Marijuana Use Frequency
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Past 6 Month Rutgers Marijuana Problem Index
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Frequency of Past Month Alcohol Consumption
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Typical Quantity in Standard Drinks Consumed on a Typical Occasion in the Past Month
timeFrame: Baseline and 6 months, Baseline and 12 months
Other outcomes:
measure: Change in Past 6 Month Relapse Prevention/Protective Behaviors Scale
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Past Year Prescription Stimulant Norms Rating Form
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ)
timeFrame: Baseline and 6 months, Baseline and 12 months
measure: Change in Cumulative and Last Semester/Quarter Grade Point Average (GPA)
timeFrame: 6 and 12 month follow-up
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: