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Valproate Efficacy in Cocaine-Bipolar Comorbidity

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami
ClinicalTrials.gov Identifier:
NCT00240110
First received: October 13, 2005
Last updated: August 24, 2016
Last verified: August 2016
  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
Drug: Placebo
Drug: Lithium Carbonate
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:
  • Change From Baseline in Percentage of Cocaine-abstinent Days [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)


Secondary Outcome Measures:
  • Change From Baseline in Percentage of Money Spent on Cocaine [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    Change from baseline in percentage of the amount of money spent on cocaine


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: Lithium carbonate add on Placebo
Lithium carbonate started and stabilized then participants randomized to placebo
Drug: Placebo
Control arm
Other Name: Placebo control
Drug: Lithium Carbonate
All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder
Other Name: Standard treatment
Experimental: Lithium carbonate add on Valproate
Lithium carbonate started and stabilized then participants randomized to Valproate
Drug: Valproate
Valproate with dose titration to achieve blood levels within the therapeutic range
Other Name: Divalproex sodium
Drug: Lithium Carbonate
All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder
Other Name: Standard treatment

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   (Adult)
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, Department of Psychiatry
Miami, Florida, United States, 33136
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
National Institute on Drug Abuse (NIDA)
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  R01DA019992  05080018  DPMCDA 
Study First Received: October 13, 2005
Results First Received: June 30, 2015
Last Updated: August 24, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Miami:
Bipolar
Cocaine
Comorbidity

Additional relevant MeSH terms:
Bipolar Disorder
Cocaine-Related Disorders
Bipolar and Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Valproic Acid
Lithium Carbonate
Cocaine
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antidepressive Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents

ClinicalTrials.gov processed this record on December 06, 2016