Optimizing Pharmacotherapy for Bipolar Alcoholics

NCT00302133 | Completed Phase 1 Results

• 2 other identifiers: RO1-AA015385-01 -SalloumR01AA015385-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Alcohol Dependence

Keywords

Alcoholism Bipolar Disorder Pharmacotherapy Naltrexone

Outcome Measures

Primary Outcomes (1)

• Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial

  12 weeks

Secondary Outcomes (1)

• % Subjects Abstinent

  12 weeks

Study Arms (2)

Naltrexone add on to valproate

EXPERIMENTAL

Naltrexone hydrochloride 50 mg capsule daily for 12 weeks add on to valproate

Drug: Naltrexone hydrochloride

Placebo add on to valproate

PLACEBO COMPARATOR

Placebo comparator one capsule daily for 12 weeks add on to valproate

Other: Placebo

Interventions

Naltrexone hydrochloride DRUG

Naltrexone hydrochloride 50 mg capsule daily for 12 weeks

Also known as: Revia

Naltrexone add on to valproate

Placebo OTHER

Placebo arm

Placebo add on to valproate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for current alcohol dependence and a concurrent bipolar disorder

You may not qualify if:

• \) Schizophrenia, schizoaffective and any nonbipolar psychotic disorder, unipolar major depression, primary anxiety disorder,mental retardation and signs of impaired cognitive functioning.
• \) Opiate dependence, abuse, or on opioid maintenance treatment for any reason and those with positive urine screen for opiate.
• )Current DSM-IV criteria for dependence on substances other that alcohol, cannabis,nicotine or caffeine.
• \) Neurological conditions including epilepsy, history of brain injury,encephalitis or any organic brain syndrome or documented focally abnormal EEG.
• )Medical conditions including severe cardiac, liver, kidney, endocrine, hematologic, or other impairing medical conditions, or impending surgery
• )Pregnancy
• )Inability or unwillingness to use contraceptive methods
• )Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

High early drop-out rate leading to small number of subjects analyzed.

Results Point of Contact

• Title: Ihsan Salloum, MD, MPH
• Organization: University of Miami Miller School of Medicine

isalloum@med.miami.edu

305 243-7931

Study Officials

• Ihsan M Salloum, MD, MPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 17, 2016
• Results First Posted: November 5, 2014

Record last verified: 2016-04

Locations

US (1)