Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Brief Marijuana Intervention for Adolescent Women - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Stein, MD, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00227864
First received: September 27, 2005
Last updated: April 15, 2013
Last verified: April 2013

September 27, 2005
April 15, 2013
September 2004
December 2009   (final data collection date for primary outcome measure)
Marijuna use [ Time Frame: marijuana use at 6 months ] [ Designated as safety issue: No ]
Marijuna use
Complete list of historical versions of study NCT00227864 on ClinicalTrials.gov Archive Site
Sex-risk behavior [ Time Frame: sex-risk behavior at 6 months ] [ Designated as safety issue: No ]
Sex-risk behavior
Not Provided
Not Provided
 
A Brief Marijuana Intervention for Adolescent Women - 1
A Brief Marijuana Intervention for Adolescent Women

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Marijuana Abuse
  • Sexual Risk Behaviors
Behavioral: Behavior Therapy
  • Placebo Comparator: Treatment as Usual
    Participants are administered assessments at baseline, 1, 3 and 6 months
  • Experimental: Intervention
    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: Behavioral: Behavior Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

current marijuana use; currently sexually active; able to complete the study procedures in English

Exclusion Criteria:

pregnant; alcohol dependence; drug dependence

Female
15 Years to 24 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00227864
NIDA-18954-1, R01DA018954, R01-18954-1
Not Provided
Michael Stein, MD, National Institute on Drug Abuse (NIDA)
Butler Hospital
National Institute on Drug Abuse (NIDA)
Principal Investigator: Michael Stein, M.D. Rhode Island Hospital
Butler Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP