CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
Naltrexone hydrochloride +1 moredrug
Likely dose
Naltrexone hydrochloride 50 mg capsule daily for 12 weeksAI-extracted
Key inclusion· 2
  • ✓Diagnosed with DSM-IV criteria for current alcohol dependence
  • ✓Diagnosed with concurrent bipolar disorder
Key exclusion· 6
  • ✕Schizophrenia, schizoaffective disorder, nonbipolar psychotic disorders, unipolar major depression, primary anxiety disorder, mental retardation, or signs of impaired cognitive functioning
  • ✕Opiate dependence, abuse, opioid maintenance treatment, or positive urine screen for opioids
  • ✕DSM-IV dependence on substances other than alcohol, cannabis, nicotine, or caffeine
  • ✕Neurological conditions including epilepsy, history of brain injury, encephalitis, organic brain syndrome, or documented focally abnormal EEG

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00302133
NCT00302133Phase 2Completed
CompareCT.gov

Optimizing Pharmacotherapy for Bipolar Alcoholics

University of Miami·interventional·Posted Mar 13, 2006·Updated May 17, 2016

In Brief

A Phase 2 clinical trial evaluating Naltrexone hydrochloride and Placebo for Bipolar Disorder and Alcohol Dependence. Completed, enrolled 88 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Alcohol Dependence
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2006
Enrollment StartMay 1, 2006
Primary CompletionApr 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.9 yearsPosted 20.3 years ago

Interventions

Naltrexone hydrochloridedrug

Naltrexone hydrochloride 50 mg capsule daily for 12 weeks

Placeboother

Placebo arm