Alcohol UsePhase 3HEATNCT01473719
Emerging Adults Who Use Alcohol and Marijuana
A Phase 3 study testing motivational intervention and health education in people with Alcohol Use and Marijuana Use, run by Butler Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use, Marijuana Use, Sexually Transmitted Infections
- What is being tested?
- motivational intervention and health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 566 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Have DSM-IV diagnosis of drug abuse or dependence (other than nicotine, marijuana)
- Have DSM-IV diagnosis of alcohol dependence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alcohol Use, Marijuana Use, Sexually Transmitted Infections
- Being tested
- motivational intervention, health education
- Keywords
- alcohol use, marijuana use, STI
- Medical subject headings
- Alcohol Drinking, Marijuana Use, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interventionBehavioural
7-session individual motivationally-based intervention
health educationBehavioural
7 individual sessions focusing on health education
| Study group | Role | What they receive |
|---|---|---|
| motivational intervention | Active comparator | 7-session individual motivationally-based intervention Receives: Behavioral: motivational intervention |
| health education | Placebo comparator | 7-session individual session focusing on health education Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
alcohol use
Measured: 15 months
marijuana use
Measured: 15 months
sexually transmitted infection
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
- Investigators
- Michael D Stein, MD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473719
- Sponsor's protocol ID
- R01AA020509
- Acronym
- HEAT
- Status last verified
- Sep 2017
- First submitted
- 15 Nov 2011
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30461442Caviness 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.
PubMed 28622099Moitra 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.
PubMed 25915689Caviness 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.
PubMed 25222129
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing STIs in Emerging Adults Who Use Alcohol and Marijuana
- ClinicalTrials.gov ID
- NCT01473719
- Acronym / sponsor ID
- HEAT / R01AA020509
- Conditions
- Alcohol Use, Marijuana Use, Sexually Transmitted Infections
- Keywords
- alcohol use, marijuana use, STI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| motivational intervention | Active comparator | Behavioral: motivational intervention7-session individual motivationally-based intervention |
| health education | Placebo comparator | Behavioral: health education7-session individual session focusing on health education |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Have DSM-IV diagnosis of drug abuse or dependence (other than nicotine, marijuana)
- Have DSM-IV diagnosis of alcohol dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational intervention7-session individual motivationally-based intervention | Behavioural | motivational intervention |
| health education7 individual sessions focusing on health education | Behavioural | health education |
Primary outcome
alcohol use
Time frame: 15 months
marijuana use
Time frame: 15 months
sexually transmitted infection
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 30461442Caviness 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.
- Derived from this study: PubMed 28622099Caviness 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.
- Derived from this study: PubMed 25915689Moitra 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.
- Derived from this study: PubMed 25222129Caviness 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Stein, MD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing motivational intervention and health education in people with Alcohol Use and Marijuana Use, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alcohol use (time frame: 15 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01473719, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.