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Trial record 1 of 4 for:    salloum | Miami, Florida, U.S.
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Optimizing Pharmacotherapy for Bipolar Alcoholics

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. Identifier: NCT00302133
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : November 5, 2014
Last Update Posted : May 17, 2016
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Disorder Alcohol Dependence Drug: Naltrexone hydrochloride Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Pharmacotherapy for Bipolar Alcoholics
Study Start Date : May 2006
Actual Primary Completion Date : April 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other: Placebo
Placebo arm

Primary Outcome Measures :
  1. Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. % Subjects Abstinent [ Time Frame: 12 weeks ]
    Proportion of subjects abstinent during the last 4 weeks of the trial

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT00302133

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

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Responsible Party: Ihsan Salloum, Professor of Psychiatry, University of Miami Identifier: NCT00302133    
Other Study ID Numbers: RO1-AA015385-01 -Salloum
First Posted: March 13, 2006    Key Record Dates
Results First Posted: November 5, 2014
Last Update Posted: May 17, 2016
Last Verified: April 2016
Keywords provided by Ihsan Salloum, University of Miami:
Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Valproic Acid
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs