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Optimizing Pharmacotherapy for Bipolar Alcoholics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami
ClinicalTrials.gov Identifier:
NCT00302133
First received: March 9, 2006
Last updated: April 16, 2016
Last verified: April 2016
  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
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 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 ] [ 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
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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: R01AA015385-01-SALLOUM 
Study First Received: March 9, 2006
Results First Received: October 20, 2014
Last Updated: April 16, 2016
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016