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Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000451
First Posted: November 3, 1999
Last Update Posted: January 29, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Yale University
  Purpose
This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.

Condition Intervention Phase
Alcoholism Alcohol Dependence Drug: sertraline Drug: naltrexone Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Days abstinent

Enrollment: 198
Study Start Date: January 2003
Study Completion Date: November 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Naltrexone plus Sertraline
Drug: naltrexone
16 week outpatient study
Other Name: Revia
Experimental: 2
Naltrexone alone
Drug: sertraline
16 week outpatient study
Other Name: Zoloft
Drug: naltrexone
16 week outpatient study
Other Name: Revia

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alaska Native having biological Alaska Native ancestry.
  • Meets criteria for alcohol dependence.
  • Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
  • Stable residence to ensure that subjects can be located during the study.

Exclusion Criteria:

  • Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
  • Current use of disulfiram.
  • Psychotic or otherwise severely psychiatrically disabled.
  • Use of other psychotropic medications including antidepressants and anxiolytics.
  • Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
  • Hepatocellular disease or elevated bilirubin levels.
  • Females who are pregnant, nursing, or not using a reliable method of birth control.
  • Probation or parole requirements that might interfere with participation in the study.
  • Involvement in alcohol treatment other than provided by the study or AA.
  • Use of monoamine oxidase inhibitors in the past month.
  • Current use of Type 1C antiarrhythmics propafenone and flecainide.
  Contacts and Locations
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): NCT00000451


Locations
United States, Connecticut
New Haven, Connecticut, United States
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Dr. Stephanie O'Malley Yale University
  More Information

ClinicalTrials.gov Identifier: NCT00000451     History of Changes
Other Study ID Numbers: NIAAAOMA12028
R01AA012028 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Yale University:
Alcoholism
Alcohol Dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Naltrexone
Sertraline
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents