Marijuana SmokingNCT01863095
An Exercise App to Reduce Young Adults' MJ Use
A study testing Personalized Feedback and Exercise in people with Marijuana Smoking, run by State University of New York at Buffalo at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Marijuana Smoking
- What is being tested?
- Personalized Feedback and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Regular Marijuana user interested in cutting down on marijuana use
- Body Mass Index < 30
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Marijuana Smoking
- Being tested
- Personalized Feedback and Exercise
- Medical subject headings
- Marijuana Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Feedback and ExerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Personalized Feedback and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
Counts based on data collected by accelerometers.
Measured: Change in exercise at 1 month, 3 months, and 6 months after interventionts
Substance Use
Measured: Change in marijuana use at 1 month, 3 months, and 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marijuana SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Lorraine Collins, Ph.D., State University of New York at Buffalo
- Investigators
- R Lorraine Collins, Ph.D., Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863095
- Sponsor's protocol ID
- R34DA035358
- Status last verified
- Jan 2016
- First submitted
- 21 May 2013
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Exercise to Reduce Young Adult Marijuana Use: There is an App for That
- ClinicalTrials.gov ID
- NCT01863095
- Acronym / sponsor ID
- R34DA035358
- Conditions
- Marijuana Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Personalized Feedback and ExerciseMJ 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. |
| Personalized Feedback only | Active comparator | Behavioral: Personalized Feedback and ExerciseMJ 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Regular Marijuana user interested in cutting down on marijuana use
- Body Mass Index < 30
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Feedback and Exercise | Behavioural | Lifestyle counseling, Personalized Feedback only |
Primary outcome
Physical Activity
Time frame: Change in exercise at 1 month, 3 months, and 6 months after interventionts
Counts based on data collected by accelerometers.
Substance Use
Time frame: Change in marijuana use at 1 month, 3 months, and 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R Lorraine Collins, Ph.D. principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Feedback and Exercise in people with Marijuana Smoking, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (time frame: Change in exercise at 1 month, 3 months, and 6 months after interventionts). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016.