Text Size

Emerging Adults Who Use Alcohol and Marijuana (HEAT)

This study is currently recruiting participants.
Verified March 2013 by Butler Hospital
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01473719
First received: November 15, 2011
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Alcohol Use
Marijuana Use
Sexually Transmitted Infections
 Behavioral: motivational intervention
Behavioral: health education
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing STIs in Emerging Adults Who Use Alcohol and Marijuana

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • alcohol use [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • marijuana use [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • sexually transmitted infection [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: January 2012
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01473719

Contacts
Contact: Michael D Stein, MD 401-455-6646 mstein@butler.org

Locations
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Michael D Stein, MD Butler Hospital
  More Information

No publications provided

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01473719     History of Changes
Other Study ID Numbers: R01 AA020509
Study First Received: November 15, 2011
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Butler Hospital:
alcohol use
marijuana use
STI

Additional relevant MeSH terms:
Alcohol Drinking
Marijuana Abuse
Marijuana Smoking
Sexually Transmitted Diseases
Drinking Behavior
Substance-Related Disorders
Mental Disorders
 Smoking
Habits
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013