NCT00227864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

5.3 years

First QC Date

September 27, 2005

Last Update Submit

November 10, 2015

Conditions

Keywords

marijuanasexual risk

Outcome Measures

Primary Outcomes (1)

  • Marijuna use

    marijuana use at 6 months

Secondary Outcomes (1)

  • Sex-risk behavior

    sex-risk behavior at 6 months

Study Arms (2)

Treatment as Usual

PLACEBO COMPARATOR

Participants are administered assessments at baseline, 1, 3 and 6 months

Other: Treatment as Usual

Intervention

EXPERIMENTAL

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

Interventions

Intervention
Treatment as Usual

Eligibility Criteria

Age15 Years - 24 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • pregnant; alcohol dependence; drug dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Behavior TherapyTherapeutics

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael Stein, M.D.

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 28, 2005

Study Start

September 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations