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Personalized Health Assessment Related to Medications (Project PHARM)

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ClinicalTrials.gov Identifier: NCT03037476
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Irene Geisner, University of Washington

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 web-based and in-person formats for use with college students who have misused PSMs.

Condition or disease Intervention/treatment Phase
Feedback, Psychological Clinical Trial Substance Abuse Behavioral: Web-based PFI Behavioral: In-person PFI Not Applicable

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) Conduct screening and RCT through a university counseling center and healthcare center utilizing in-person and web-based PSM interventions compared to control.

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, Study 3 entails conducting screening and a RCT through a university counseling center and healthcare center. Eligible students will be randomized to one of 3 conditions: in-person PFI, web-based PFI, or control. Both of the interventions aim to reduce perceived benefits of PSM, normative perceptions of PSM, and increase alternative behaviors, thereby reducing PSM and other substance use (specifically marijuana and alcohol). Participants complete a follow-up assessment at 6 months post-baseline to evaluate intervention efficacy. The investigators hypothesize: 1) both web- and in-person PFI will be more efficacious than control, 2) the in-person intervention will be more efficacious than web at 6 month follow-up, and 3) reductions in perceived benefits and norms of PSM and increases in alternative behaviors will mediate efficacy of both interventions, as will reductions in alcohol and marijuana use. Demographics and PSM motives will be explored as moderators of overall and differential efficacy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Personalized Health Assessment Related to Medications (Project PHARM)
Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Web-Based PFI
Participants randomized to the web-based PFI in Studies 2 and 3 will 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
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.

Experimental: In-person PFI
Participants randomized to the in-person PFI condition in Study 3 will be scheduled to meet with a trained intervention provider in a Student Counseling and Health Center setting for a 1.5 hour session to discuss the student's PSM misuse, alcohol and other drug use, and review personalized graphic feedback. The intervention provider will utilize a motivational interviewing approach in reviewing the students personalized feedback with them. They will use the student's past experiences with PSM as a starting point and will help the student to develop discrepancies, elicit change talk, provide students with opportunities to more thoroughly explore and question their beliefs, and offer alternatives by reviewing their personalized responses.
Behavioral: In-person PFI
A 1.5 hour in-person brief personalized feedback intervention utilizing a motivational interviewing approach to discuss the student's PSM misuse, alcohol and other drug use, and review personalized graphic feedback.

No Intervention: Control
The control group will only receive assessments in Studies 2 and 3.



Primary Outcome Measures :
  1. Change in Non-Medical Use of Prescription Stimulant Medication Frequency [ Time Frame: 6 and 12 month follow-up ]
    Assesses frequency of non-medical use of prescription stimulant medications.

  2. Change in Medical Use, Medical Misuse, and Non-Medical Use Questionnaire [ Time Frame: 6 and 12 month follow-up ]
    Assesses lifetime and past 6 month medical use, medical misuse, and non-medical use of prescription drugs.

  3. Change in Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief screen/assessment tool (TAPS Tool) [ Time Frame: 6 and 12 month follow-up ]
    Assesses problematic use of tobacco, alcohol, prescription, and illicit drugs over the past year and 3 months.

  4. Change in Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) - Stimulants Only [ Time Frame: 6 and 12 month follow-up ]
    Measures past 3 month non-medical use of prescription stimulants and associated negative consequences over the past 3 months.

  5. Change in Prescription Stimulant Use Consequence Questionnaire [ Time Frame: 6 and 12 month follow-up ]
    Assesses negative consequences associated with prescription stimulant misuse over the previous 6 months.


Secondary Outcome Measures :
  1. Change in Quantity/Frequency/Peak Alcohol Use Index [ Time Frame: 6 and 12 month follow-up ]
    Assesses typical drinking quantity, frequency, and quantity of peak episode of alcohol consumption over the past month.

  2. Change in Daily Drinking Questionnaire [ Time Frame: 6 and 12 month follow-up ]
    Assesses typical alcohol consumption over the course of a typical week.

  3. Change in Rutgers Alcohol Problem Index [ Time Frame: 6 and 12 month follow-up ]
    Measures negative alcohol-related consequences experienced over the past 6 months.

  4. Change in Marijuana Use Frequency [ Time Frame: 6 and 12 month follow-up ]
    Items measure typical frequency of marijuana use and number of days used in the past year, 6 months, and 30 days.

  5. Change in Rutgers Marijuana Problem Index [ Time Frame: 6 and 12 month follow-up ]
    Items measure frequency of experiencing negative consequences while using marijuana or as a result of marijuana use over the previous 6 months.


Other Outcome Measures:
  1. Change in Relapse Prevention/Protective Behaviors Scale [ Time Frame: 6 and 12 month follow-up ]
    Measures the use of relapse prevention strategies and protective behaviors related to stimulant medication misuse.

  2. Change in Prescription Stimulant Norms Rating Form [ Time Frame: 6 and 12 month follow-up ]
    Assesses the perceived percentage of students who have misused prescription stimulant medication in the past year, 6 months, and 30 days.

  3. Change in Motivated Strategies for Learning Questionnaire (MSLQ) [ Time Frame: 6 and 12 month follow-up ]
    Measures the use of different types of learning strategies and academic motivations.

  4. Change in Grade Point Average (GPA) [ Time Frame: 6 and 12 month follow-up ]
    Participants report their cumulative and previous semester/quarter GPA.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Currently enrolled as a student at the participating campus and in their second semester/quarter or later.
  • Has an anticipated graduation date at least 6 months into the future
  • Between 18-25 year olds
  • Misuse of prescription stimulants in the past year

Study 3 Exclusion Criteria:

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

Information from the National Library of Medicine

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): NCT03037476


Contacts
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Contact: Irene M Geisner, Ph.D. 206-419-8999 geisner@uw.edu
Contact: Nicole Fossos-Wong, B.S. 206-685-1499 njf2@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Irene M Geisner, Ph.D.    206-419-8999    geisner@uw.edu   
Contact: Nicole Fossos-Wong, B.S.    206-685-1499    njf2@uw.edu   
Principal Investigator: Irene M Geisner, Ph.D.         
Principal Investigator: Jason R Kilmer, Ph.D.         
Principal Investigator: M. Dolores Cimini, Ph.D.         
Principal Investigator: Amelia M Arria, Ph.D.         
Sub-Investigator: Mary E Larimer, Ph.D.         
Sub-Investigator: Christine M Lee, Ph.D.         
Sub-Investigator: Isaac C Rhew, Ph.D.         
Sub-Investigator: Karen L Sokolowski, Ph.D.         
Sub-Investigator: Estela M Rivero, Ph.D.         
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)

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Responsible Party: Irene Geisner, Assistant Professor, Psychiatry and Behavioral Sciences, University of Washington
ClinicalTrials.gov Identifier: NCT03037476     History of Changes
Other Study ID Numbers: 51051
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs