Optimizing Pharmacotherapy for Bipolar Alcoholics
This study is currently recruiting participants.
Verified February 2013 by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami
ClinicalTrials.gov Identifier:
NCT00302133
First received: March 9, 2006
Last updated: February 19, 2013
Last verified: February 2013
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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 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:
Drug Information available for:
Valproic acid
Valproate sodium
Naltrexone
Naltrexone hydrochloride
Divalproex sodium
U.S. FDA Resources
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.
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 |
Locations
| 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
Investigators
| 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:
|
Alcoholism Bipolar Disorder Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Affective Disorders, Psychotic Mood Disorders Valproic Acid Naltrexone Anticonvulsants 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 May 19, 2013