Back to resultsEmerging Adults Who Use Alcohol and Marijuana (HEAT)
Primary Purpose
Alcohol Use, Marijuana Use, Sexually Transmitted Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
motivational intervention
health education
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use focused on measuring alcohol use, marijuana use, STI
Eligibility 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
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
motivational intervention
health education
Arm Description
7-session individual motivationally-based intervention
7-session individual session focusing on health education
Outcomes
Primary Outcome Measures
alcohol use
marijuana use
sexually transmitted infection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01473719
Brief Title
Emerging Adults Who Use Alcohol and Marijuana
Acronym
HEAT
Official Title
Reducing STIs in Emerging Adults Who Use Alcohol and Marijuana
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use, Marijuana Use, Sexually Transmitted Infections
Keywords
alcohol use, marijuana use, STI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
566 (Actual)
8. Arms, Groups, and Interventions
Arm Title
motivational intervention
Arm Type
Active Comparator
Arm Description
7-session individual motivationally-based intervention
Arm Title
health education
Arm Type
Placebo Comparator
Arm Description
7-session individual session focusing on health education
Intervention Type
Behavioral
Intervention Name(s)
motivational intervention
Intervention Description
7-session individual motivationally-based intervention
Intervention Type
Behavioral
Intervention Name(s)
health education
Intervention Description
7 individual sessions focusing on health education
Primary Outcome Measure Information:
Title
alcohol use
Time Frame
15 months
Title
marijuana use
Time Frame
15 months
Title
sexually transmitted infection
Time Frame
15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael D Stein, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30461442
Citation
Caviness CM, Anderson BJ, Stein MD. Impact of Nicotine and Other Stimulants on Sleep in Young Adults. J Addict Med. 2019 May/Jun;13(3):209-214. doi: 10.1097/ADM.0000000000000481.
Results Reference
derived
PubMed Identifier
28622099
Citation
Caviness CM, Anderson BJ, Stein MD. Energy drinks and alcohol-related risk among young adults. Subst Abus. 2017 Oct-Dec;38(4):376-381. doi: 10.1080/08897077.2017.1343217. Epub 2017 Jun 16.
Results Reference
derived
PubMed Identifier
25915689
Citation
Moitra E, Christopher PP, Anderson BJ, Stein MD. Coping-motivated marijuana use correlates with DSM-5 cannabis use disorder and psychological distress among emerging adults. Psychol Addict Behav. 2015 Sep;29(3):627-32. doi: 10.1037/adb0000083. Epub 2015 Apr 27.
Results Reference
derived
PubMed Identifier
25222129
Citation
Caviness CM, Tzilos G, Anderson BJ, Stein MD. Synthetic Cannabinoids: Use and Predictors in a Community Sample of Young Adults. Subst Abus. 2015;36(3):368-73. doi: 10.1080/08897077.2014.959151. Epub 2014 Sep 15.
Results Reference
derived
Learn more about this trial
Emerging Adults Who Use Alcohol and Marijuana
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