Valproate Efficacy in Cocaine-Bipolar Comorbidity

August 24, 2016 updated by: Ihsan Salloum, University of Miami
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.

Study Overview

Status

Completed

Conditions

Intervention / 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

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine, Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (Estimate)

October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

October 17, 2016

Last Update Submitted That Met QC Criteria

August 24, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20070289
  • DPMCDA (Other Identifier: NIDA)
  • R01DA019992 (U.S. NIH Grant/Contract)
  • 05080018 (Other Identifier: NIDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe