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
  Purpose

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.


Condition Intervention Phase
Marijuana Abuse
Sexual Risk Behaviors
Behavioral: Behavior Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Brief Marijuana Intervention for Adolescent Women

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Marijuna use [ Time Frame: marijuana use at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sex-risk behavior [ Time Frame: sex-risk behavior at 6 months ] [ Designated as safety issue: No ]

Enrollment: 326
Study Start Date: September 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Behavior Therapy

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.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

pregnant; alcohol dependence; drug dependence

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00227864

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Michael Stein, M.D. Rhode Island Hospital
  More Information

No publications provided by Butler Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Stein, MD, PI, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00227864     History of Changes
Other Study ID Numbers: NIDA-18954-1, R01DA018954, R01-18954-1
Study First Received: September 27, 2005
Last Updated: April 15, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014