A Brief Marijuana Intervention for Adolescent Women - 1
Primary Purpose
Marijuana Abuse, Sexual Risk Behaviors
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Behavior Therapy
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Marijuana Abuse focused on measuring marijuana, sexual risk
Eligibility Criteria
Inclusion Criteria: current marijuana use; currently sexually active; able to complete the study procedures in English Exclusion Criteria: pregnant; alcohol dependence; drug dependence
Sites / Locations
- Rhode Island Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Treatment as Usual
Intervention
Arm Description
Participants are administered assessments at baseline, 1, 3 and 6 months
Participants complete assessments at baseline, 1, 3 and 6 months, and receive a 2-session behavioral intervention at the baseline and 1-month study appointments.
Outcomes
Primary Outcome Measures
Marijuna use
Secondary Outcome Measures
Sex-risk behavior
Full Information
NCT ID
NCT00227864
First Posted
September 27, 2005
Last Updated
November 10, 2015
Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00227864
Brief Title
A Brief Marijuana Intervention for Adolescent Women - 1
Official Title
A Brief Marijuana Intervention for Adolescent Women
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse, Sexual Risk Behaviors
Keywords
marijuana, sexual risk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
Participants are administered assessments at baseline, 1, 3 and 6 months
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants complete assessments at baseline, 1, 3 and 6 months, and receive a 2-session behavioral intervention at the baseline and 1-month study appointments.
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Primary Outcome Measure Information:
Title
Marijuna use
Time Frame
marijuana use at 6 months
Secondary Outcome Measure Information:
Title
Sex-risk behavior
Time Frame
sex-risk behavior at 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
current marijuana use; currently sexually active; able to complete the study procedures in English
Exclusion Criteria:
pregnant; alcohol dependence; drug dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stein, M.D.
Organizational Affiliation
Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24439950
Citation
Stein MD, Caviness CM, Anderson BJ. Alcohol use potentiates marijuana problem severity in young adult women. Womens Health Issues. 2014 Jan-Feb;24(1):e77-82. doi: 10.1016/j.whi.2013.10.005.
Results Reference
derived
PubMed Identifier
23795877
Citation
Caviness CM, Hagerty CE, Anderson BJ, de Dios MA, Hayaki J, Herman D, Stein MD. Self-efficacy and motivation to quit marijuana use among young women. Am J Addict. 2013 Jul-Aug;22(4):373-80. doi: 10.1111/j.1521-0391.2013.12030.x.
Results Reference
derived
PubMed Identifier
21185685
Citation
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. doi: 10.1016/j.jsat.2010.11.001. Epub 2010 Dec 24.
Results Reference
derived
Learn more about this trial
A Brief Marijuana Intervention for Adolescent Women - 1
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