Overview

This trial is active, not recruiting.

Conditions alcohol use, marijuana use, sexually transmitted infections
Treatments motivational intervention, health education
Phase phase 4
Sponsor Butler Hospital
Start date January 2012
End date August 2016
Trial size 566 participants
Trial identifier NCT01473719, R01AA020509

Summary

The purpose of this study is to if a brief motivational intervention, compared to health education sessions, reduces alcohol and marijuana use and is related to fewer sexually transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
7-session individual motivationally-based intervention
motivational intervention
7-session individual motivationally-based intervention
(Placebo Comparator)
7-session individual session focusing on health education
health education
7 individual sessions focusing on health education

Primary Outcomes

Measure
alcohol use
time frame: 15 months
marijuana use
time frame: 15 months
sexually transmitted infection
time frame: 15 months

Eligibility Criteria

Male or female participants from 18 years up to 25 years old.

Inclusion Criteria: - Be between the ages of 18 and 25 - Binge drink (5 or more drinks in a 2-hour period for men, 4 or more for women) at least monthly - Use marijuana at least weekly - Have been heterosexually active in the past six months - Are not married - Have not been living with a sexual or romantic partner for more than 6 months - Be English speaking - Reside within 20 miles of Providence, RI and plans to stay in the geographic area for the next 15 months - Provide contact information for at least two verifiable locator persons Exclusion Criteria: - Have DSM-IV diagnosis of drug abuse or dependence (other than nicotine, marijuana) - Have DSM-IV diagnosis of alcohol dependence

Additional Information

Official title Reducing STIs in Emerging Adults Who Use Alcohol and Marijuana
Principal investigator Michael D Stein, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Butler Hospital.