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Optimizing Pharmacotherapy for Bipolar Alcoholics
This study is currently recruiting participants.
Verified by National Institute on Alcohol Abuse and Alcoholism (NIAAA), February 2009
First Received: March 9, 2006   Last Updated: February 24, 2009   History of Changes
Sponsors and Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Miami
Information provided by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier: NCT00302133
  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 add on to open label valproate
Phase I
Phase II

MedlinePlus related topics: Alcoholism Bipolar Disorder
Drug Information available for: Naltrexone Naltrexone hydrochloride Divalproex sodium Valproic acid Valproate Sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Optimizing Pharmacotherapy for Bipolar Alcoholics

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: May 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Naltrexone add on to valproate: Experimental
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

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00302133

Contacts
Contact: Ihsan M Salloum, MD, MPH 305-243-7931 isalloum@med.miami.edu
Contact: Carleen Robinson, LCSW, ABD 305-243-1298 CRobins2@med.miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Carleen Robinson, LSCW, ABD     305-243-1298     CRobins2@med.miami.edu    
Contact: Alicia Frasca, CCRP     305-243-7951     afrasca@med.miami.edu    
Principal Investigator: Ihsan M. Salloum, MD, MPH            
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Ihsan M Salloum, MD, MPH University of Miami Miller School of Medicine
  More Information

No publications provided

Responsible Party: University of Miami ( Ihsan M. Salloum, MD, MPH (Principal Investigator) )
Study ID Numbers: RO1-AA015385-01 -Salloum
Study First Received: March 9, 2006
Last Updated: February 24, 2009
ClinicalTrials.gov Identifier: NCT00302133     History of Changes
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

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Bipolar Disorder
Narcotic Antagonists
Psychotropic Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Antimanic Agents
Valproic Acid
Affective Disorders, Psychotic
Mental Disorders
Alcoholism
Naltrexone
Substance-Related Disorders
Mood Disorders
Alcohol-Related Disorders
Psychotic Disorders
Peripheral Nervous System Agents
Anticonvulsants

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Narcotic Antagonists
Psychotropic Drugs
Disorders of Environmental Origin
Valproic Acid
Affective Disorders, Psychotic
Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Alcohol-Related Disorders
Tranquilizing Agents
Bipolar Disorder
Central Nervous System Depressants
Enzyme Inhibitors
Antimanic Agents
Pharmacologic Actions
Naltrexone
Alcoholism
Mood Disorders
GABA Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009