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An Exercise App to Reduce Young Adults' MJ Use

Primary Purpose

Marijuana Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Feedback and Exercise
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Marijuana Smoking

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Regular Marijuana user interested in cutting down on marijuana use
  • Body Mass Index < 30

Exclusion Criteria:

  • Pregnant or planning to become pregnant
  • No legal problems
  • No substance abuse diagnosis
  • No history of substance abuse treatment
  • Medical contraindications to engaging in exercise
  • Psychological distress or psychiatric treatment

Sites / Locations

  • Center for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle counseling

Personalized Feedback only

Arm Description

MJ users assigned to this condition will participate in 4 individualized intervention sessions that are based on Motivational Interviewing principles. They will receive personalized feedback on their MJ use and will be provided a smart phone app on which they report their MJ use episodes, which also is designed to promote the use of exercise/physical activity as an alternative to MJ use. Level of Physical activity will be measured using accelerometers.

MJ users assigned to this condition will participate in 4 individualized intervention sessions that are based on Motivational Interviewing principles. They will only receive personalized feedback on their MJ use.

Outcomes

Primary Outcome Measures

Physical Activity
Counts based on data collected by accelerometers.
Substance Use

Secondary Outcome Measures

Full Information

First Posted
May 21, 2013
Last Updated
January 29, 2016
Sponsor
State University of New York at Buffalo
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1. Study Identification

Unique Protocol Identification Number
NCT01863095
Brief Title
An Exercise App to Reduce Young Adults' MJ Use
Official Title
Use of Exercise to Reduce Young Adult Marijuana Use: There is an App for That
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently, marijuana (MJ) is the most popular illicit drug, but there are few effective interventions to help young adults (age 18 to 25 years) to reduce their MJ intake. In this study, we will develop and initially test a smart phone app designed to promote exercise/physical activity as a positive alternative to MJ use. The app will be tested in an efficacy study in which MJ users are randomly to either receive personalized feedback about MJ use + use the exercise app or personalized feedback only. The results will contribute to knowledge about exercise/physical activity as a strategy for reducing young adults' MJ use and problems.
Detailed Description
Currently, marijuana (MJ) is the most popular illicit drug, with prevalence studies indicating increasing use among young adults (Johnston et al., 2011). Even so, there are few effective interventions to help MJ users reduce their intake to avoid negative consequences, including MJ dependence. The investigators propose a Stage 1 efficacy study to develop and initially test an innovative intervention to reduce MJ use among young adults who regularly use MJ (> 3 episodes/week). The intervention includes elements from the Marijuana Check-Up (MCU; Stephens et al., 2007), a MI-based brief intervention that has shown promise for reducing MJ use. It also incorporates findings from our ongoing research, which suggest that exercise/physical activity (PA) has potential as a positive alternative to MJ use. The investigators research also has shown that short (i.e., 10 minute) bouts of moderate or intense exercise reduce craving/urges to use MJ. Exercise interventions have successfully reduced use of licit substances, such as tobacco (e.g., Marcus et al., 2005) and alcohol (e.g., Brown et al., 2009), but have not been adequately tested for MJ use. The two aims of this R34 application are: 1) To develop an intervention that consists of four, 60-minute, in-person sessions composed of MCU content (e.g., personalized feedback, MI) as well as a smart phone application (app) that promotes exercise/physical activity (EA) as an alternative to MJ use. The EA, which will be designed to specifically appeal to young adults, will provide a readily-accessible, flexible, and convenient platform for personalized information and reminders that promote exercise/PA as a positive alternative to MJ use in ongoing daily life. 2) To conduct a pilot/efficacy study of the 4-week MCU+EA intervention vs. a MCU-only control condition. The investigators will use urn randomization to assign emerging/young-adult MJ users (N = 40) to the two conditions. During the 1-week baseline, 4-week intervention phase, and 1-, 3-, and 6-month follow-ups, all participants will use the smart phone app to provide real-time data on MJ-related variables and wear accelerometers to provide PA data. Multilevel modeling will be used to test our hypothesis that the MCU+EA intervention, compared to MCU-only control, will produce greater decreases in quantity and frequency of MJ use (and related MJ problems) at post-intervention and at each follow-up. Multilevel modeling also will be used to explore the real-time data to examine the role of variables such as urge/craving for MJ, social factors, and dosage of PA in the reduction of the quantity and frequency of MJ use. This Stage 1 study is unique and innovative in its development and use of a smart phone app to promote and evaluate exercise/PA as a positive alternative to MJ use in daily life. It includes cutting-edge technology (e.g., accelerometers, smart phone app) for real-time assessments. This research will make significant contributions to the limited knowledge of exercise/PA as a strategy for reducing MJ use and related problems among emerging and young adults.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
MJ users assigned to this condition will participate in 4 individualized intervention sessions that are based on Motivational Interviewing principles. They will receive personalized feedback on their MJ use and will be provided a smart phone app on which they report their MJ use episodes, which also is designed to promote the use of exercise/physical activity as an alternative to MJ use. Level of Physical activity will be measured using accelerometers.
Arm Title
Personalized Feedback only
Arm Type
Active Comparator
Arm Description
MJ users assigned to this condition will participate in 4 individualized intervention sessions that are based on Motivational Interviewing principles. They will only receive personalized feedback on their MJ use.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Feedback and Exercise
Primary Outcome Measure Information:
Title
Physical Activity
Description
Counts based on data collected by accelerometers.
Time Frame
Change in exercise at 1 month, 3 months, and 6 months after interventionts
Title
Substance Use
Time Frame
Change in marijuana use at 1 month, 3 months, and 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Regular Marijuana user interested in cutting down on marijuana use Body Mass Index < 30 Exclusion Criteria: Pregnant or planning to become pregnant No legal problems No substance abuse diagnosis No history of substance abuse treatment Medical contraindications to engaging in exercise Psychological distress or psychiatric treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R Lorraine Collins, Ph.D.
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Research
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

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An Exercise App to Reduce Young Adults' MJ Use

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