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Emerging Adults Who Use Alcohol and Marijuana (HEAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01473719
First received: November 15, 2011
Last updated: September 15, 2017
Last verified: September 2017
  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 3

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

Resource links provided by NLM:


Further study details as provided by Michael Stein, MD, Butler Hospital:

Primary Outcome Measures:
  • alcohol use [ Time Frame: 15 months ]
  • marijuana use [ Time Frame: 15 months ]
  • sexually transmitted infection [ Time Frame: 15 months ]

Enrollment: 566
Actual Study Start Date: January 2012
Study Completion Date: August 2017
Primary Completion Date: August 2017 (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   (Adult)
Sexes Eligible for Study:   All
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
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: NCT01473719

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01473719     History of Changes
Other Study ID Numbers: R01AA020509 ( U.S. NIH Grant/Contract )
Study First Received: November 15, 2011
Last Updated: September 15, 2017

Keywords provided by Michael Stein, MD, Butler Hospital:
alcohol use
marijuana use
STI

Additional relevant MeSH terms:
Alcohol Drinking
Marijuana Abuse
Sexually Transmitted Diseases
Drinking Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017