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Optimizing Pharmacotherapy for Bipolar Alcoholics

This study has been completed.
University of Miami
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami Identifier:
First received: March 9, 2006
Last updated: November 4, 2014
Last verified: November 2014

The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

Condition Intervention Phase
Bipolar Disorder
Alcohol Dependence
Drug: Naltrexone hydrochloride
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Pharmacotherapy for Bipolar Alcoholics

Resource links provided by NLM:

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % Subjects Abstinent [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects abstinent during the last 4 weeks of the trial

Enrollment: 88
Study Start Date: May 2006
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone add on to valproate
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate
Drug: Naltrexone hydrochloride
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks
Other Name: Revia
Placebo Comparator: Placebo add on to valproate
Placebo comparator one capsule daily for 12 weeks add on to valproate

Detailed Description:

Bipolar disorder has the highest rate of association with alcohol and other substance use disorders. This complex clinical presentation is asociated with severe disabilities,morbidity and heightened risk for suicide. There is a significant gap in our knowledge regarding effective treatment interventions for this high risk clinical population. This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid alcohol dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of valproate plus naltrexone vs. valproate alone in decreasing alcohol use and stabilizing mood symptoms among patients with comorbid alcohol dependence and bipolar disorder. All participants receive supportive psychosocial treatment.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder

Exclusion Criteria:

  • 1) Schizophrenia, schizoaffective and any nonbipolar psychotic disorder, unipolar major depression, primary anxiety disorder,mental retardation and signs of impaired cognitive functioning.
  • 2) Opiate dependence, abuse, or on opioid maintenance treatment for any reason and those with positive urine screen for opiate.
  • 3)Current DSM-IV criteria for dependence on substances other that alcohol, cannabis,nicotine or caffeine.
  • 4) Neurological conditions including epilepsy, history of brain injury,encephalitis or any organic brain syndrome or documented focally abnormal EEG.
  • 5)Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, or other impairing medical conditions, or impending surgery
  • 6)Pregnancy
  • 7)Inability or unwillingness to use contraceptive methods
  • 8)Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol
  Contacts and Locations
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Please refer to this study by its identifier: NCT00302133

United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Principal Investigator: Ihsan M Salloum, MD, MPH University of Miami
  More Information

No publications provided

Responsible Party: Ihsan Salloum, Professor of Psychiatry, University of Miami Identifier: NCT00302133     History of Changes
Other Study ID Numbers: RO1-AA015385-01 -Salloum
Study First Received: March 9, 2006
Results First Received: October 20, 2014
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Mood Disorders
Substance-Related Disorders
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 20, 2014