Back to resultsValproate Efficacy in Cocaine-Bipolar Comorbidity
Primary Purpose
Bipolar Disorder, Cocaine Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Valproate
Placebo
Lithium Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar, Cocaine, Comorbidity
Eligibility 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.
Sites / Locations
- University of Miami Miller School of Medicine, Department of Psychiatry
- University of Miami Miller School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Lithium carbonate add on Placebo
Lithium carbonate add on Valproate
Arm Description
Lithium carbonate started and stabilized then participants randomized to placebo
Lithium carbonate started and stabilized then participants randomized to Valproate
Outcomes
Primary Outcome Measures
Change From Baseline in Percentage of Cocaine-abstinent Days
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
Change from baseline in percentage of the amount of money spent on cocaine
Full Information
NCT ID
NCT00240110
First Posted
October 13, 2005
Last Updated
August 24, 2016
Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00240110
Brief Title
Valproate Efficacy in Cocaine-Bipolar Comorbidity
Official Title
Valproate Efficacy in Cocaine-Bipolar Comorbidity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
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.
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.
Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Cocaine Dependence
Keywords
Bipolar, Cocaine, Comorbidity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lithium carbonate add on Placebo
Arm Type
Placebo Comparator
Arm Description
Lithium carbonate started and stabilized then participants randomized to placebo
Arm Title
Lithium carbonate add on Valproate
Arm Type
Experimental
Arm Description
Lithium carbonate started and stabilized then participants randomized to Valproate
Intervention Type
Drug
Intervention Name(s)
Valproate
Other Intervention Name(s)
Divalproex sodium
Intervention Description
Valproate with dose titration to achieve blood levels within the therapeutic range
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo control
Intervention Description
Control arm
Intervention Type
Drug
Intervention Name(s)
Lithium Carbonate
Other Intervention Name(s)
Standard treatment
Intervention Description
All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder
Primary Outcome Measure Information:
Title
Change From Baseline in Percentage of Cocaine-abstinent Days
Description
Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in Percentage of Money Spent on Cocaine
Description
Change from baseline in percentage of the amount of money spent on cocaine
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ihsan M Salloum, MD, MPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine, Department of Psychiatry
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16814474
Citation
Salloum IM, Douaihy A, Cornelius JR, Kirisci L, Kelly TM, Hayes J. Divalproex utility in bipolar disorder with co-occurring cocaine dependence: a pilot study. Addict Behav. 2007 Feb;32(2):410-5. doi: 10.1016/j.addbeh.2006.05.007. Epub 2006 Jun 30.
Results Reference
background
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Valproate Efficacy in Cocaine-Bipolar Comorbidity
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