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A Brief Marijuana Intervention for Adolescent Women - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00227864
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : November 11, 2015
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Michael Stein, MD, National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE September 27, 2005
First Posted Date  ICMJE September 28, 2005
Last Update Posted Date November 11, 2015
Study Start Date  ICMJE September 2004
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2013)
Marijuna use [ Time Frame: marijuana use at 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
Marijuna use
Change History Complete list of historical versions of study NCT00227864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2013)
Sex-risk behavior [ Time Frame: sex-risk behavior at 6 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
Sex-risk behavior
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Marijuana Abuse
  • Sexual Risk Behaviors
Intervention  ICMJE
  • Behavioral: Behavior Therapy
  • Other: Treatment as Usual
Study Arms  ICMJE
  • Placebo Comparator: Treatment as Usual
    Participants are administered assessments at baseline, 1, 3 and 6 months
    Intervention: Other: Treatment as Usual
  • 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
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: September 27, 2005)
326
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual 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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00227864
Other Study ID Numbers  ICMJE NIDA-18954-1
R01DA018954 ( U.S. NIH Grant/Contract )
R01-18954-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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
Principal Investigator: Michael Stein, M.D. Rhode Island Hospital
PRS Account Butler Hospital
Verification Date November 2015

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