NCT01863095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 1, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

May 21, 2013

Last Update Submit

January 29, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Physical Activity

    Counts based on data collected by accelerometers.

    Change in exercise at 1 month, 3 months, and 6 months after interventionts

  • Substance Use

    Change in marijuana use at 1 month, 3 months, and 6 months after intervention

Study Arms (2)

Lifestyle counseling

EXPERIMENTAL

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.

Behavioral: Personalized Feedback and Exercise

Personalized Feedback only

ACTIVE COMPARATOR

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.

Behavioral: Personalized Feedback and Exercise

Interventions

Lifestyle counselingPersonalized Feedback only

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health Research

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Marijuana Smoking

Interventions

Exercise

Condition Hierarchy (Ancestors)

Marijuana UseBehaviorSmoking, Non-Tobacco ProductsSmoking

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • R Lorraine Collins, Ph.D.

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Community Health and Health Behavior

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 27, 2013

Study Start

October 1, 2014

Primary Completion

May 1, 2015

Study Completion

June 1, 2015

Last Updated

February 1, 2016

Record last verified: 2016-01

Locations