Optimizing Pharmacotherapy for Bipolar Alcoholics

Bipolar Disorder Clinical Trial

Official title:

Optimizing Pharmacotherapy for Bipolar Alcoholics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302133
• Other study ID #: RO1-AA015385-01 -Salloum
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 9, 2006
• Last updated: November 24, 2015
• Start date: May 2006
• Est. completion date: July 2013

Study information

• Verified date: November 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the efficacy of naltrexone and valproate in the treatment of comorbid bipolar disorder and alcohol dependence.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Bipolar Disorder

Intervention

Drug:
• Naltrexone hydrochloride
Naltrexone hydrochloride 50 mg capsule daily for 12 weeks

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial		12 weeks	No
Secondary	% Subjects Abstinent	Proportion of subjects abstinent during the last 4 weeks of the trial	12 weeks	No