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Reducing Alcohol Use in Depressed Patients

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ClinicalTrials.gov Identifier: NCT00183079
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : November 7, 2014
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:
The purpose of this study is to determine whether a brief alcohol intervention reduces alcohol use and improves depression among depressed patients.

Condition or disease Intervention/treatment Phase
Depression Alcohol Use Behavioral: Motivationally-focused brief alcohol intervention Phase 2

Detailed Description:

Heavy alcohol consumption is common among patients seeking treatment for depression. Heavy drinking is associated with a variety of medical and psychosocial problems. Heavy drinking is particularly problematic among depressed patients, increasing the likelihood of poor depression treatment outcomes. While methods for reducing alcohol use in this population have been unexplored to date, brief interventions to reduce heavy alcohol use have been well-validated in numerous patient populations and offer the promise to reduce heavy drinking among depressed patients and to improve depression treatment outcomes.

We hypothesize that adding a brief alcohol intervention to standard psychiatric care, relative to standard psychiatric care alone, will reduce overall drinking volume and heavy drinking days among heavy-drinking depressed patients. Furthermore, we expect patients who receive the brief alcohol intervention to have better depression outcomes than patients receiving standard psychiatric care alone. We also expect that reduced alcohol consumption will mediate the effect of the brief alcohol intervention on depression outcomes. In addition, we will examine individual difference variables as predictors of change in alcohol use.

The proposed study is a randomized, two-group design with repeated measures over time, comparing a brief, motivationally-focused alcohol intervention plus standard psychiatric care to standard psychiatric care alone. For this study, we will recruit a sample of 240 psychiatry clinic outpatients meeting structured diagnostic criteria for major depressive disorder who drink heavily but are not alcohol dependent.

We expect that the results of this study will improve depression treatment outcomes for the significant subpopulation of depression patients who drink heavily and are likely to do poorly in depression treatment in the absence of a change in their drinking behavior. The intervention proposed in this study represents a novel approach to reducing heavy drinking among depressed patients that, if effective, can be readily integrated into depression treatment in a variety of treatment settings. In addition, this study will provide valuable information on the association between alcohol use and depression outcomes and on the mechanisms of change in alcohol use among heavy-drinking depressed patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brief Alcohol Intervention With Depressed Patients
Study Start Date : March 2004
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Brief, motivationally-focused alcohol intervention
Behavioral: Motivationally-focused brief alcohol intervention
Brief, motivationally-focused alcohol intervention

Primary Outcome Measures :
  1. Alcohol consumption [ Time Frame: 6 months ]
  2. Depressive symptoms [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 years of age or older
  • Meet criteria for current Major Depressive Disorder
  • Have consumed more than 14 drinks per week or more than 5 drinks on one occasion in the past month for men or more than 7 drinks per week or more than 4 drinks on one occasion in the past month for females

Exclusion Criteria:

  • Meet criteria for current alcohol dependence or current psychoactive substance dependence (excluding nicotine)
  • Currently psychotic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00183079

United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02860
Sponsors and Collaborators
Rhode Island Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Susan E. Ramsey, Ph.D. Rhode Island Hospital

Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00183079     History of Changes
Other Study ID Numbers: NIAAARAM13895
R01AA013895 ( U.S. NIH Grant/Contract )
NIH 5 R01 AA13895
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: October 2008

Keywords provided by Rhode Island Hospital:
Alcohol Use
Motivational Interviewing

Additional relevant MeSH terms:
Alcohol Drinking
Behavioral Symptoms
Drinking Behavior
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs