Sertraline and Cognitive Therapy in Depressed Alcoholics
NCT ID: NCT00000458
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2002-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sertraline (Zoloft)
cognitive behavior therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meets criteria for alcohol abuse or dependence thirty days prior to entering the study.
* Has had no more than one previous inpatient medical detoxification.
* Able to maintain sobriety for ten days.
* Able to read and understand questionnaires and informed consent.
* Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting.
Exclusion Criteria
* Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study.
* Meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder.
* Has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication.
* Patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study.
* Current use of disulfiram (Antabuse) or anti-seizure medications.
* Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion.
* Hepatocellular disease.
* Females who are pregnant, nursing, or not using a reliable form of birth control.
* Current charges pending for violent crime (excluding DUI related offenses).
* Previous adverse experience with a serotonin reuptake inhibitor.
* Current homicidal or suicidal ideation.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIAAAMOA10476
Identifier Type: -
Identifier Source: org_study_id