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Trial record 2 of 4 for:    salloum | Miami, Florida, U.S.

Valproate Efficacy in Cocaine-Bipolar Comorbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240110
Recruitment Status : Completed
First Posted : October 17, 2005
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami

Tracking Information
First Submitted Date  ICMJE October 13, 2005
First Posted Date  ICMJE October 17, 2005
Results First Submitted Date  ICMJE June 30, 2015
Results First Posted Date  ICMJE October 17, 2016
Last Update Posted Date October 17, 2016
Study Start Date  ICMJE March 2006
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
Change From Baseline in Percentage of Cocaine-abstinent Days [ Time Frame: Week 12 ]
Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
This will be operationalized as an increase in the weekly mean proportion of self-report cocaine-abstinent (non-use) days confirmed by urine screen.
Change History Complete list of historical versions of study NCT00240110 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
Change From Baseline in Percentage of Money Spent on Cocaine [ Time Frame: week 12 ]
Change from baseline in percentage of the amount of money spent on cocaine
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
  • The valproate group will show advantage over the placebo group as demonstrated by:
  • 1. Higher percentage of cocaine-abstinent days by self report.
  • 2. Higher proportion of subjects with total abstinence
  • 3. Higher proportion of negative urine for other drugs
  • 4. Longer time to relapse to cocaine use (defined as time to first day of use).
  • 5. Reduced overall severity of cocaine use as assessed by the CGI-S, CGI-O, cocaine craving scales, and the ASI's drug and alcohol severity indices
  • 6. Reduced severity of HIV risk behavior as measured by the HRBS.
  • The valproate treated group will also have advantage over the placebo group on reduced manic and depressive symptoms and will have a higher rate of mania and depression remission.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valproate Efficacy in Cocaine-Bipolar Comorbidity
Official Title  ICMJE Valproate Efficacy in Cocaine-Bipolar Comorbidity
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:

  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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar Disorder
  • Cocaine Dependence
Intervention  ICMJE
  • Drug: Valproate
    Valproate with dose titration to achieve blood levels within the therapeutic range
    Other Name: Divalproex sodium
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Lithium carbonate add on Placebo
    Lithium carbonate started and stabilized then participants randomized to placebo
    Interventions:
    • Drug: Placebo
    • Drug: Lithium Carbonate
  • Experimental: Lithium carbonate add on Valproate
    Lithium carbonate started and stabilized then participants randomized to Valproate
    Interventions:
    • Drug: Valproate
    • Drug: Lithium Carbonate
Publications * 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. Epub 2006 Jun 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2014)
152
Original Enrollment  ICMJE
 (submitted: October 13, 2005)
104
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00240110
Other Study ID Numbers  ICMJE 20070289
R01DA019992 ( U.S. NIH Grant/Contract )
05080018 ( Other Identifier: NIDA )
DPMCDA ( Other Identifier: NIDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ihsan Salloum, University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Ihsan M Salloum, MD, MPH University of Miami
PRS Account University of Miami
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP