Attempts to Stop/Reduce Marijuana Among Dependent Users
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 24, 2009 | ||||
| Last Updated Date | October 31, 2012 | ||||
| Start Date ICMJE | June 2010 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
initiation of a quit or reduction attempt [ Time Frame: during 3 months of monitoring ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01039415 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
duration of a quit attempt [ Time Frame: during the 3 months of monitoring ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Attempts to Stop/Reduce Marijuana Among Dependent Users | ||||
| Official Title ICMJE | Attempts to Stop/Reduce Marijuana Among Dependent Users | ||||
| Brief Summary | The purpose of the study is to determine why and how marijuana users stop or reduce their marijuana use. |
||||
| Detailed Description | The major aim of this study is to provide a better understanding of attempts to stop or reduce marijuana use that can be used to develop better behavioral treatments for marijuana dependence. The application will focus on adult daily marijuana users who try to stop or reduce their marijuana use in a real-world setting. Although prospective, natural history studies describing attempts to stop or reduce alcohol, heroin and tobacco use have proved useful, we know of no such study among adult marijuana users. Two pilot studies will develop measures and assess compliance with our procedures. The main study will recruit up to 400 adult marijuana smokers with the goal of a sample size of 200 participants with adequate compliance. Participants will call an Interactive Voice Recording (IVR) system daily for 3 months to report marijuana use, quit/reduction attempts, and events that might increase or decrease the probability of initiating a quit/reduction attempt or the success of an attempt. Follow-up at 6 months will track recent marijuana and other drug use. Knowing what motivates marijuana users to try to stop or reduce, and knowing which strategies for stopping marijuana use are successful, can help develop treatments for marijuana dependence. For example, if stopping tobacco when trying to stop marijuana decreases the chance of stopping marijuana, then smoking cessation should be done after stopping marijuana. Or if reducing marijuana often leads to cessation, then convincing those not interested in quitting marijuana to first try reducing may be helpful. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | adults 18 and older |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 234 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01039415 | ||||
| Other Study ID Numbers ICMJE | CHRBS #09-005, R01DA024691 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | John Hughes, University of Vermont | ||||
| Study Sponsor ICMJE | University of Vermont | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Vermont | ||||
| Verification Date | October 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||