Emerging Adults Who Use Alcohol and Marijuana (HEAT)

September 15, 2017 updated by: Michael Stein, MD, Butler Hospital

Reducing STIs in Emerging Adults Who Use Alcohol and Marijuana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

566

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, 02906
        • Butler 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

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: motivational intervention
7-session individual motivationally-based intervention
Behavioral: motivational intervention
7-session individual motivationally-based intervention
Placebo Comparator: health education
7-session individual session focusing on health education
Behavioral: health education
7 individual sessions focusing on health education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
alcohol use
Time Frame: 15 months
15 months
marijuana use
Time Frame: 15 months
15 months
sexually transmitted infection
Time Frame: 15 months
15 months

Collaborators and Investigators

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

Sponsor

Butler Hospital

Investigators

  • Principal Investigator: Michael D Stein, MD, Butler 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 (Actual)

January 1, 2012

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

November 15, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 15, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AA020509 (U.S. NIH Grant/Contract)

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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