- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863095
An Exercise App to Reduce Young Adults' MJ Use
January 29, 2016 updated by: R. Lorraine Collins, Ph.D., State University of New York at Buffalo
Use of Exercise to Reduce Young Adult Marijuana Use: There is an App for That
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14214
- Center for Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lifestyle counseling
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.
|
|
Active Comparator: Personalized Feedback only
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity
Time Frame: Change in exercise at 1 month, 3 months, and 6 months after interventionts
|
Counts based on data collected by accelerometers.
|
Change in exercise at 1 month, 3 months, and 6 months after interventionts
|
Substance Use
Time Frame: Change in marijuana use at 1 month, 3 months, and 6 months after intervention
|
Change in marijuana use at 1 month, 3 months, and 6 months after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: R Lorraine Collins, Ph.D., State University of New York at Buffalo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
May 21, 2013
First Submitted That Met QC Criteria
May 24, 2013
First Posted (Estimate)
May 27, 2013
Study Record Updates
Last Update Posted (Estimate)
February 1, 2016
Last Update Submitted That Met QC Criteria
January 29, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34DA035358 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Marijuana Smoking
-
Western University, CanadaRecruitingCannabis Use | Marijuana Smoking | Cannabis Smoking | Marijuana UsageCanada
-
RANDNational Institute on Alcohol Abuse and Alcoholism (NIAAA)CompletedAlcohol Drinking | Cigarette Smoking | Marijuana SmokingUnited States
-
Yale UniversityCompleted
-
Yale UniversityCompleted
-
Pacific Institute for Research and EvaluationCompletedSmoking | Alcohol Drinking | Marijuana SmokingUnited States
-
Brown UniversityCompleted
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene...CompletedMarijuana SmokingUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)Completed
-
National Institute on Drug Abuse (NIDA)Completed
-
New York State Psychiatric InstituteNational Institute on Drug Abuse (NIDA); Research Foundation for Mental Hygiene...Completed
Clinical Trials on Personalized Feedback and Exercise
-
TNOWageningen University and Research; Google LLC.; Jumbo Supermarkten Bv.; Noldus...Completed
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedWeight | Food Choice | Nutrition IntakeUnited States
-
University of HoustonCompletedHeavy DrinkingUnited States
-
Centre for Addiction and Mental HealthCompleted
-
University of WashingtonNational Institute on Drug Abuse (NIDA)CompletedCannabis | Alcohol Consumption | GamblingUnited States
-
Seattle Children's HospitalUnknown
-
Centre for Addiction and Mental HealthCompleted
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Active, not recruiting
-
University of South CarolinaUniversity of Vermont; University of TennesseeCompleted
-
University of OklahomaOklahoma Center for the Advancement of Science and TechnologyCompletedTobacco Use Cessation | Tobacco Smoking Behavior | Cigarette Smoking Behavior | Second Hand Tobacco SmokeUnited States