Personalized Health Assessment Related to Medications (Project PHARM)

NCT03037476 | Completed Results DMC

• 2 other identifiers: STUDY000017823U01DA040219-04S1
• Study Type: interventional
• Target: 843
• Locations: 1 country
• Sites: 1

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.

Conditions

Feedback, Psychological; Clinical Trial; Substance Abuse

Outcome Measures

Primary Outcomes (5)

• Change in Past 6 Month Non-Medical Use of Prescription Stimulant Medication Frequency

  Assesses frequency of non-medical use of prescription stimulant medications. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).

  Baseline and 6 months, Baseline and 12 months

• Change in Past 6 Month Medical Misuse of Prescription Stimulant Medication

  Assesses past 6 month medical misuse of prescription stimulant medication. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).

  Baseline and 6 months, Baseline and 12 months

• Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool (TAPS Tool)

  Assesses problematic use of tobacco, alcohol, prescription, and illicit drugs over the past year and 3 months. Response options included: 0= Never, 1= Less than Monthly, 2= Monthly, 3= Weekly, 4= Daily or Almost Daily. Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).

  Baseline and 6 months, Baseline and 12 months

• Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only

  Measures past 3 month non-medical use of prescription stimulants and associated negative consequences. Items were summed to create a scale summary score where higher values indicated more problematic use in the past 3 months (min=0, max=40). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).

  Baseline and 6 months, Baseline and 12 months

• Change in Past 6 Month Prescription Stimulant Use Consequence Questionnaire

  Assesses negative consequences associated with prescription stimulant misuse over the previous 6 months. A score of "0" indicates that a given consequence did not occur and a score of "1" indicates that it did occur. Items were summed to create a scale summary score of overall number of unique consequences that occurred in the past 6 months (min=0, max=19). Change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline and the value at 12 months minus the value at baseline).

  6 and 12 month follow-up

Secondary Outcomes (7)

• Change in Peak Quantity of Alcohol Consumed in Past Month

  Baseline and 6 months, Baseline and 12 months

• Change in Past 6 Month Daily Drinking Questionnaire

  Baseline and 6 months, Baseline and 12 months

• Change in Past 6 Month Rutgers Alcohol Problem Index

  Baseline and 6 months, Baseline and 12 months

• Change in Past Year, 6 Month, and 30 Day Marijuana Use Frequency

  Baseline and 6 months, Baseline and 12 months

• Change in Past 6 Month Rutgers Marijuana Problem Index

  Baseline and 6 months, Baseline and 12 months

Other Outcomes (4)

• Change in Past 6 Month Relapse Prevention/Protective Behaviors Scale

  Baseline and 6 months, Baseline and 12 months

• Change in Past Year Prescription Stimulant Norms Rating Form

  Baseline and 6 months, Baseline and 12 months

• Change in Current Semester/Quarter Motivated Strategies for Learning Questionnaire (MSLQ)

  Baseline and 6 months, Baseline and 12 months

Study Arms (2)

Web-Based PFI

EXPERIMENTAL

Participants randomized to the web-based PFI in Study 2 receive a 5 component Personalized Feedback Tool. The first component is presented immediately after the baseline survey and a link to each of the remaining 4 components is sent to participants spaced 1 to 2 weeks apart. The PFI components cover: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol. Each component is comprised of personalized feedback presented in text and graphic format, and each component includes links to tips for making changes if and when the participant is contemplating or ready to commit to change. These tips include general relapse prevention strategies, as well as information about the importance of regular class attendance, study habits, and sleep habits for academic success. General educational tips/strategies for time management, as well as tips for initiating behavior change are also included. Each component takes approximately 5-10 minutes to review.

Behavioral: Web-based PFI

Assessment Only

OTHER

The Assessment Only group receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6-month follow-up, and 12-month follow-up in Study 2.

Behavioral: Assessment Only

Interventions

Web-based PFI BEHAVIORAL

A web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol.

Web-Based PFI

Assessment Only BEHAVIORAL

The Assessment Only condition receives assessment on substance use, health behaviors, and academic behaviors at baseline, 6 month follow-up, and 12 month follow-up.

Assessment Only

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Jason Kilmer, Ph.D.
• Organization: University of Washington

jkilmer@uw.edu

206-685-4512

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Psychiatry

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 31, 2017
• Study Start: March 30, 2017
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)