Valproate Efficacy in Cocaine-Bipolar Comorbidity

NCT00240110 | Completed Phase 1 Results DMC

• 4 other identifiers: 20070289R01DA01999205080018DPMCDA
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

Bipolar Disorder; Cocaine Dependence

Keywords

Bipolar; Cocaine; Comorbidity

Outcome Measures

Primary Outcomes (1)

• 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)

  Week 12

Secondary Outcomes (1)

• Change From Baseline in Percentage of Money Spent on Cocaine

  week 12

Study Arms (2)

Lithium carbonate add on Placebo

PLACEBO COMPARATOR

Lithium carbonate started and stabilized then participants randomized to placebo

Drug: Placebo; Drug: Lithium Carbonate

Lithium carbonate add on Valproate

EXPERIMENTAL

Lithium carbonate started and stabilized then participants randomized to Valproate

Drug: Valproate; Drug: Lithium Carbonate

Interventions

Valproate DRUG

Valproate with dose titration to achieve blood levels within the therapeutic range

Also known as: Divalproex sodium

Lithium carbonate add on Valproate

Placebo DRUG

Control arm

Also known as: Placebo control

Lithium carbonate add on Placebo

Lithium Carbonate DRUG

All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder

Also known as: Standard treatment

Lithium carbonate add on Placebo; Lithium carbonate add on Valproate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Miami Miller School of Medicine, Department of Psychiatry

Miami, Florida, 33136, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 16814474 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder; Cocaine-Related Disorders

Interventions

Valproic Acid; Lithium Carbonate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Results Point of Contact

• Title: Dr. Ihsan Salloum
• Organization: Univeristy of Miami

isalloum@med.miami.edu

305-243-7931

Study Officials

• Ihsan M Salloum, MD, MPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: March 1, 2006
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: October 17, 2016
• Results First Posted: October 17, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)