A Brief Marijuana Intervention for Adolescent Women - 1
| Tracking Information | |||||
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| First Received Date ICMJE | September 27, 2005 | ||||
| Last Updated Date | April 15, 2013 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Marijuna use [ Time Frame: marijuana use at 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Marijuna use | ||||
| Change History | Complete list of historical versions of study NCT00227864 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Sex-risk behavior [ Time Frame: sex-risk behavior at 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Sex-risk behavior | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Brief Marijuana Intervention for Adolescent Women - 1 | ||||
| Official Title ICMJE | A Brief Marijuana Intervention for Adolescent Women | ||||
| Brief Summary | The purpose of this study is to examine the efficacy of a brief motivational intervention on marijuana use and sex-risk behavior in young women. |
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| Detailed Description | This study holds the promise of developing a brief, efficacious intervention to reduce marijuana use and related sexual risk-taking behavior among the large populaton of late adolescent women who are regular marijuana users. In the abscence of intervention, these women are at heightened risk of contracting HIV and other sexually transmitted infections. Therefore it is crucial to develop an intervention that will reduce their marijuana and subsequent sexual risk taking behavior. The intervention employed in this study represents a novel adaptation of interventions that are well-supported with similar populations. If the current intervention is found to be efficacious, it can be readily integrated into a variety of treatment settings, particularly other primary care settings. In addition, this study will contribute valuable information about the relationship between marijuana use and sexual risk taking behavior and about the mechanisms of change in marijuana use in late adolescent women. Comparison(s): Participants will be assigned, in this 6 month longitudinal study, to an assessment-only group or an assessment plus intervention group. Those in the intervention group will receive 2 motivational intervention sessions during the first 3 months of their study participation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Behavior Therapy | ||||
| Study Arm (s) |
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| Publications * | Stein MD, Hagerty CE, Herman DS, Phipps MG, Anderson BJ. A brief marijuana intervention for non-treatment-seeking young adult women. J Subst Abuse Treat. 2011 Mar;40(2):189-98. Epub 2010 Dec 24. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 326 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: current marijuana use; currently sexually active; able to complete the study procedures in English Exclusion Criteria: pregnant; alcohol dependence; drug dependence |
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| Gender | Female | ||||
| Ages | 15 Years to 24 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00227864 | ||||
| Other Study ID Numbers ICMJE | NIDA-18954-1, R01DA018954, R01-18954-1 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Michael Stein, MD, National Institute on Drug Abuse (NIDA) | ||||
| Study Sponsor ICMJE | Butler Hospital | ||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Investigators ICMJE |
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| Information Provided By | Butler Hospital | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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