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Improving Brief Marijuana Interventions With a Behavioral Economic Supplement (BLUE-J)

Primary Purpose

Marijuana Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Motivational Intervention (BMI)
Substance-Free Activity Session (SFAS)
Relaxation Session
Sponsored by
University of Memphis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • freshman or sophomore at the university of Memphis
  • 5 or more past-month days of marijuana use

Exclusion Criteria:

-

Sites / Locations

  • University of Memphis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

BMI + SFAS

BMI + Relaxation Session

Assessment

Arm Description

Participants first receive a 50-minute standard brief motivational intervention designed to reduce marijuana use. A week later, they will receive the SFAS (Substance-free Activity Session., a 50-minute counseling session designed to increase the salience of the student's academic and career goals, draw attention to the potentially negative relationship between substance use and goal accomplishment, and increase engagement in substance-free alternative activities. The SFAS was described to participants as the "College Adjustment Session" and the session was conducted using an MI plus personalized feedback approach.

Participants first receive a 50-minute standard brief motivational intervention designed to reduce marijuana use. A week later, they will receive a relaxation training session. In the relaxation training session, the clinician leads the student through a diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, students were asked about their reaction to the relaxation techniques and were provided with relaxation training handouts.

Participants fill out a battery of measures and receive no intervention.

Outcomes

Primary Outcome Measures

Change in Marijuana use
Electronic timeline follow-back to measure marijuana use days

Secondary Outcome Measures

Full Information

First Posted
July 11, 2016
Last Updated
May 1, 2017
Sponsor
University of Memphis
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02837315
Brief Title
Improving Brief Marijuana Interventions With a Behavioral Economic Supplement
Acronym
BLUE-J
Official Title
Improving Brief Marijuana Interventions With a Behavioral Economic Supplement
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 23, 2014 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Memphis
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of a Substance-Free Activity Session (SFAS) as a supplement to a brief motivation intervention (BMI) in reducing marijuana use and drug-related consequences in college student
Detailed Description
Approximately 20% of college students are regular marijuana users, and are at risk for cognitive and academic problems, addiction, and risk behaviors such as driving while impaired. Young adult marijuana users are thus a high-risk population and may require an intervention that motivates marijuana reductions by increasing engagement in constructive alternatives to marijuana use. Brief Motivational Interventions (BMIS) have demonstrated efficacy for alcohol use in college students, but lack consistent evidence of efficacy for marijuana use. This research team has developed a supplement to alcohol BMIs, the Substance-Free Activity Session (SFAS), which directly targets the behavioral economic mechanisms of both substance-free reinforcement and delayed reward discounting by encouraging the development of and commitment to academic and career goals, and by highlighting the impact of day-to-day patterns of alcohol use and academic engagement on these goals. A controlled pilot trial found that the SFAS improved BMI outcomes in a sample of heavy drinking college students, and the ongoing parent trial to this revision is replicating and extending those results. This study will evaluate the SFAS using a randomized 3-group (BMI + SFAS vs. BMI + Relaxation Attention Control, vs. Assessment Only) pilot trial with 120 undergraduates (50% female, 40% minority) who report using marijuana on > 5 days in the past-month. It is hypothesized that at the 1-month and the next-semester follow-ups (follow-ups are wedded to the academic calendar to allow for representative measurement of marijuana use and activity patterns) BMI+SFAS participants will report significantly lower levels of marijuana use and problems, and that these reductions will exceed those of BMI + Relaxation and Assessment-Only participants. Exploratory analyses will test the hypotheses that (a) the BMI + SFAS will be more effective for participants who report higher baseline marijuana reinforcing efficacy and delayed reward discounting; and (b) the advantage of BMI + SFAS on marijuana use will be mediated by increased participation in substance-free activities. Support for our hypotheses would extend behavioral economic theory and would provide initial validation for an approach that could be used to reduce marijuana misuse among the increasing population of college students who misuse marijuana. Furthermore, given the focus of the SFAS is to increase academic/campus engagement, this work has the potential for widespread dissemination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMI + SFAS
Arm Type
Experimental
Arm Description
Participants first receive a 50-minute standard brief motivational intervention designed to reduce marijuana use. A week later, they will receive the SFAS (Substance-free Activity Session., a 50-minute counseling session designed to increase the salience of the student's academic and career goals, draw attention to the potentially negative relationship between substance use and goal accomplishment, and increase engagement in substance-free alternative activities. The SFAS was described to participants as the "College Adjustment Session" and the session was conducted using an MI plus personalized feedback approach.
Arm Title
BMI + Relaxation Session
Arm Type
Active Comparator
Arm Description
Participants first receive a 50-minute standard brief motivational intervention designed to reduce marijuana use. A week later, they will receive a relaxation training session. In the relaxation training session, the clinician leads the student through a diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, students were asked about their reaction to the relaxation techniques and were provided with relaxation training handouts.
Arm Title
Assessment
Arm Type
No Intervention
Arm Description
Participants fill out a battery of measures and receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention (BMI)
Intervention Description
This session includes a discussion related to harm reduction and the student's autonomy to make decisions about the information provided in the session; a marijuana use decisional balance exercise; personalized marijuana-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the student's perception of how much college students use marijuana and actual student norms, (b) a comparison of the student's marijuana use vs. norms, (c) drug-related problems experienced, (e) money spent on marijuana, and (f) alcohol norms and consequences if participants indicated they also drink alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if she or she indicates interest.
Intervention Type
Behavioral
Intervention Name(s)
Substance-Free Activity Session (SFAS)
Intervention Description
The clinician initiates a discussion of the student's college and career goals. Students discuss the values that motivate them as well as how marijuana use may interfere with their ability to accomplish these goals. Students then receive information on graduation rates and income benefits for those who attend and excel in college. They receive personalized feedback on (a) the requirements for their major and intended career, (b) a list of extracurricular activities tailored to their goals, (c) a graph showing time they allocate to their activities, (d) information on stress and depressive symptoms (if applicable) and possible adaptive coping responses and (e) a list of substance-free recreational activities in which they would like to start or continuing engaging.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Session
Intervention Description
The session includes a clinician-led diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, students are asked about their reaction to the relaxation techniques and are provided with relaxation training handouts.
Primary Outcome Measure Information:
Title
Change in Marijuana use
Description
Electronic timeline follow-back to measure marijuana use days
Time Frame
Baseline, 1-month, 6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: freshman or sophomore at the university of Memphis 5 or more past-month days of marijuana use Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James G Murphy, Ph.D.
Organizational Affiliation
University of Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38152
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Researchers will maintain a de-identified database and after publishing the primary outcomes, they will make individual level data available to researchers who are conducting integrated analyses.

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Improving Brief Marijuana Interventions With a Behavioral Economic Supplement

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