Alcohol ConsumptionPhase 1MCIDNCT01204229
Motivational and Cognitive Intervention for College Drinkers
A Phase 1 study testing Motivational and Cognitive Intervention for Drinkers (MCID) and Brief Motivational Intervention (BMI) in people with Alcohol Consumption and Anxiety, run by University of Cincinnati at 1 site in United States.
Trial summary
In the proposed project the investigators will develop and test a novel brief intervention targeting college students who drink heavily to cope with anxiety and depression, a behavior that increases risk for the development of alcohol dependence. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Consumption, Anxiety, Depression
- What is being tested?
- Motivational and Cognitive Intervention for Drinkers (MCID) and Brief Motivational Intervention (BMI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2012
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 1. At least 1 heavy drinking episode (4 or more drinks for women; 5 or more drinks for men).
- 2. Sub-clinical anxiety or depression 3. Occasional to frequent drinking related problems
Who cannot join
- 1. Clinical Axis I diagnosis 2. Current suicidal ideation, pregnancy, major medical illness, severe alcohol dependence, current hallucinations
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Psychology Department, University of Cincinnati
Cincinnati, Ohio, 45221
Giao Q. Tran, Ph.D., 513-237-2608, Giao.Tran@uc.edu
About this study
In the proposed project the investigators will develop and test a novel brief intervention targeting college students who drink heavily to cope with anxiety and depression, a behavior that increases risk for the development of alcohol dependence.
- Conditions
- Alcohol Consumption, Anxiety, Depression
- Being tested
- Motivational and Cognitive Intervention for Drinkers (MCID), Brief Motivational Intervention (BMI)
- Keywords
- Alcohol Consumption, Social Anxiety, Depression, Brief Intervention, Motivational Interviewing, Cognitive Behavioral Therapy, Sub-Clinical Social Anxiety, Sub-Clinical Depression
- Medical subject headings
- Alcohol Drinking, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational and Cognitive Intervention for Drinkers (MCID)Behavioural
Integrate social anxiety/ depression and drinking intervention
Brief Motivational Intervention (BMI)Behavioural
Integrate drinking intervention
| Study group | Role | What they receive |
|---|---|---|
| MCID | Experimental | Not described Receives: Behavioral: Motivational and Cognitive Intervention for Drinkers (MCID) |
| BMI | Experimental | Not described Receives: Behavioral: Brief Motivational Intervention (BMI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Consumption and Drinking-Related Negative Consequences
Measured: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
Anxiety
Measured: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
Depression
Measured: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
Secondary outcomes (1)
Cost efficacy data
Measured: 2-3 months post completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Giao Q. Tran, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204229
- Sponsor's protocol ID
- R21AA1AA017291A1
- Other IDs
- R21AA1AA017291A1
- Acronym
- MCID
- Status last verified
- Apr 2011
- First submitted
- 15 Sep 2010
- Last updated
- 22 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational and Cognitive Intervention for College Drinkers
- ClinicalTrials.gov ID
- NCT01204229
- Acronym / sponsor ID
- MCID / R21AA1AA017291A1
- Conditions
- Alcohol Consumption, Anxiety, Depression
- Keywords
- Alcohol Consumption, Social Anxiety, Depression, Brief Intervention, Motivational Interviewing, Cognitive Behavioral Therapy, Sub-Clinical Social Anxiety, Sub-Clinical Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2010
- Primary completion
- May 2012 (estimated)
- First posted
- 17 Sep 2010 (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.
In the proposed project the investigators will develop and test a novel brief intervention targeting college students who drink heavily to cope with anxiety and depression, a behavior that increases risk for the development of alcohol dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCID | Experimental | Behavioral: Motivational and Cognitive Intervention for Drinkers (MCID) |
| BMI | Experimental | Behavioral: Brief Motivational Intervention (BMI) |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. At least 1 heavy drinking episode (4 or more drinks for women; 5 or more drinks for men).
- 2. Sub-clinical anxiety or depression 3. Occasional to frequent drinking related problems
Key exclusion criteria (1 listed)
- 1. Clinical Axis I diagnosis 2. Current suicidal ideation, pregnancy, major medical illness, severe alcohol dependence, current hallucinations
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 and Cognitive Intervention for Drinkers (MCID)Integrate social anxiety/ depression and drinking intervention | Behavioural | MCID |
| Brief Motivational Intervention (BMI)Integrate drinking intervention | Behavioural | BMI |
Primary outcome
Alcohol Consumption and Drinking-Related Negative Consequences
Time frame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
Anxiety
Time frame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
Depression
Time frame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up
1 secondary outcome
Cost efficacy data
Time frame: 2-3 months post completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2011.
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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.
Giao Q. Tran, Ph.D. principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motivational and Cognitive Intervention for Drinkers (MCID) and Brief Motivational Intervention (BMI) in people with Alcohol Consumption and Anxiety, run by University of Cincinnati 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Apr 2011. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giao Q. Tran, Ph.D. (513-237-2608, Giao.Tran@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Consumption and Drinking-Related Negative Consequences (time frame: Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up). 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?
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 22 Apr 2011.