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Optimizing Pharmacotherapy for Bipolar Alcoholics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302133
First Posted: March 13, 2006
Last Update Posted: May 17, 2016
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.
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami
  Purpose
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 Other: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Pharmacotherapy for Bipolar Alcoholics

Resource links provided by NLM:


Further study details as provided by Ihsan Salloum, University of Miami:

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

Secondary Outcome Measures:
  • % Subjects Abstinent [ Time Frame: 12 weeks ]
    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
Other: Placebo
Placebo arm

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.
  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:   Yes
Criteria

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
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): NCT00302133


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

Responsible Party: Ihsan Salloum, Professor of Psychiatry, University of Miami
ClinicalTrials.gov Identifier: NCT00302133     History of Changes
Other Study ID Numbers: RO1-AA015385-01 -Salloum
First Submitted: March 9, 2006
First Posted: March 13, 2006
Results First Submitted: October 20, 2014
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:
Bipolar Disorder
Alcoholism
Bipolar and Related Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Naltrexone
Valproic Acid
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs