Valproate Efficacy in Cocaine-Bipolar Comorbidity
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00240110
First received: October 13, 2005
Last updated: November 24, 2009
Last verified: November 2009
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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:
MedlinePlus related topics:
Bipolar Disorder
Drug Information available for:
Cocaine hydrochloride
Valproic acid
Valproate sodium
Divalproex sodium
U.S. FDA Resources
Further study details as provided by National Institute on Drug Abuse (NIDA):
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 ]
| Estimated Enrollment: | 104 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
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
|
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:
- 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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00240110
Contacts
| Contact: Ihsan M Salloum, MD, MPH | 1 305 243 7931 | isalloum@med.miami.edu |
| Contact: Carleen Robinson, LSW, PhD | 1 305 243 1298 | CRobins2@med.miami.edu |
Locations
| United States, Florida | |
| University of Miami Miller School of Medicine, Department of Psychiatry | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Ihsan M Salloum 305-243-7931 isalloum@med.miami.edu | |
| Contact: Carleen Robinson, LSW, PhD 1 305 243 1298 CRobins2@med.miami.edu | |
| Principal Investigator: Ihsan M Salloum, MD, MPH | |
| Sub-Investigator: Vineeth John, MD | |
| University of Miami Miller School of Medicine | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Ihsan M Salloum, MD, MPH 305-243-7931 isalloum@med.miami.edu | |
| Contact: Carleen Robinson, LSW, PhD 305 243 1298 CRobins2@med.miami.edu | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Ihsan M Salloum, MD, MPH | University of Miami |
More Information
Publications:
| Responsible Party: | Ihsan M. Salloum, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00240110 History of Changes |
| Other Study ID Numbers: | 05080018, R01DA019992, DPMCDA |
| Study First Received: | October 13, 2005 |
| Last Updated: | November 24, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Drug Abuse (NIDA):
|
Bipolar Cocaine |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Substance-Related Disorders Valproic Acid Cocaine Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions 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 Vasoconstrictor Agents Cardiovascular Agents Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Uptake Inhibitors Anesthetics, Local Anesthetics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013