Optimizing Pharmacotherapy for Bipolar Alcoholics

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Miami
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami
ClinicalTrials.gov Identifier:
First received: March 9, 2006
Last updated: February 19, 2013
Last verified: February 2013

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 add on to open label valproate
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:
  • Examine the efficacy of the combined pharmacotherapy treated group (valproate plus naltrexone)in decreasing the quantity and frequency of alcohol consumption,facilitating abstinence and decreasing relapse in patients with comorbid bipolar disorder and al [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine whether primary vs. secondary alcoholism, bipolar subtype (depressed vs. manic/mixed subtype,and the presence of other substance use disorders moderate the association between treatment and alcohol use outcome. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: May 2006
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone add on to valproate
valproate open label plus double blind naltrexone hydrochloride
Drug: naltrexone add on to open label valproate
naltrexone 50 mg/day for 12 weeks add on to open label valproate
Other Name: Revia

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 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

Contact: Ihsan M Salloum, MD, MPH 305-243-7931 isalloum@med.miami.edu

United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Ihsan M Salloum, MD, MPH    305-243-3179    isalloum@med.miami.edu   
Principal Investigator: Ihsan M. Salloum, MD, MPH         
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
ClinicalTrials.gov Identifier: NCT00302133     History of Changes
Other Study ID Numbers: RO1-AA015385-01 -Salloum
Study First Received: March 9, 2006
Last Updated: February 19, 2013
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
Mood Disorders
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Valproic Acid
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014