Phase 2
Completed N=18
Optimizing Pharmacotherapy for Bipolar Alcoholics
Source: ClinicalTrials.gov NCT00302133 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial — 0.6; 3.8 standard drinks/drinking day
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Standard Drinks Per Drinking Day During the Last 4 Weeks of the Trial |
0.6; 3.8 | — |
| SECONDARY % Subjects Abstinent |
66; 33 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00302133). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.