A Brief Marijuana Intervention for Adolescent Women - 1

November 10, 2015 updated by: Michael Stein, MD, Butler Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

326

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

pregnant; alcohol dependence; drug dependence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Treatment as Usual
Participants are administered assessments at baseline, 1, 3 and 6 months
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.
Behavioral: Behavior Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Marijuna use
Time Frame: marijuana use at 6 months
marijuana use at 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Sex-risk behavior
Time Frame: sex-risk behavior at 6 months
sex-risk behavior at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Michael Stein, M.D., Rhode Island Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 27, 2005

First Submitted That Met QC Criteria

September 27, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-18954-1
  • R01DA018954 (U.S. NIH Grant/Contract)
  • R01-18954-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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