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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01204229
Other study ID # R21AA1AA017291A1
Secondary ID R21AA1AA017291A1
Status Recruiting
Phase Phase 1
First received September 15, 2010
Last updated April 21, 2011
Start date May 2010

Study information

Verified date April 2011
Source University of Cincinnati
Contact Giao Q. Tran, Ph.D.
Phone 513-237-2608
Email Giao.Tran@uc.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 1. Clinical Axis I diagnosis 2. Current suicidal ideation, pregnancy, major medical illness, severe alcohol dependence, current hallucinations

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational and Cognitive Intervention for Drinkers (MCID)
Integrate social anxiety/ depression and drinking intervention
Brief Motivational Intervention (BMI)
Integrate drinking intervention

Locations

Country Name City State
United States Psychology Department, University of Cincinnati Cincinnati Ohio

Sponsors (2)

Lead Sponsor Collaborator
University of Cincinnati National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol Consumption and Drinking-Related Negative Consequences Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up No
Primary Anxiety Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up No
Primary Depression Pre-Treatment, 2-month follow-up, 4-month follow-up, 6-month follow-up No
Secondary Cost efficacy data 2-3 months post completion No
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