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Valproate Efficacy in Cocaine-Bipolar Comorbidity

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami
ClinicalTrials.gov Identifier:
NCT00240110
First received: October 13, 2005
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.


Condition Intervention Phase
Bipolar Disorder
Cocaine Dependence
Drug: Valproate vs. Placebo
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: Valproate Efficacy in Cocaine-Bipolar Comorbidity

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • This will be operationalized as an increase in the weekly mean proportion of self-report cocaine-abstinent (non-use) days confirmed by urine screen [ Time Frame: During the double-blind treatment phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of cocaine-abstinent days, proportion of participants with total abstinence, time to relapse to cocaine use, severity of cocaine use, cocaine craving scales, severity of HIV risk behavior [ Time Frame: During the double-blind treatment phase ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: March 2006
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo add on to lithium carbonate
Drug: Valproate vs. Placebo
Valproate with dose titration to achieve blood levels within the therapeutic range wil be compared to placebo
Other Name: Divalproex sodium
Experimental: 2
Valproate add on to lithium carbonate
Drug: Valproate vs. Placebo
Valproate with dose titration to achieve blood levels within the therapeutic range wil be compared to placebo
Other Name: Divalproex sodium

Detailed Description:

Bipolar disorder has the highest rate of association with cocaine and other substance use disorders than any other major severe psychiatric syndrome. This comorbidity represents a major treatment challenge and is associated with severe disability, morbidity, and heightened risk for suicide.

The aims of this study are:

  1. Examine the efficacy of valproate plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use in patients with cocaine dependence and comorbid bipolar disorder.
  2. Determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed vs. manic/mixed) and the presence of additional substance use disorders moderate the association between treatment and cocaine use outcome.
  3. Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder

Exclusion Criteria:

  • Schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolar major depression, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning.
  • Current DSM-IV criteria for dependence on substances other than cocaine, 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, or liver disease.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240110

Locations
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
University of Miami Miller School of Medicine, Department of Psychiatry
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Ihsan M Salloum, MD, MPH University of Miami
  More Information

Publications:
Responsible Party: Ihsan Salloum, Professor of Psychiatry, University of Miami
ClinicalTrials.gov Identifier: NCT00240110     History of Changes
Other Study ID Numbers: 20070289, 5R01DA019992, R01DA019992, DPMCDA, 05080018
Study First Received: October 13, 2005
Last Updated: November 19, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Miami:
Bipolar
Cocaine
Comorbidity

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Cocaine
Valproic Acid
Anesthetics
Anesthetics, Local
Anticonvulsants
Antimanic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 24, 2014