Serotonin, Impulsivity, and Cocaine Dependence Treatment - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00297505

Purpose

The purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.

Condition	Intervention	Phase
Cocaine Dependence	Drug: citalopram	Phase II

Drug Information available for: Serotonin Cocaine hydrochloride Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Serotonin, Impulsivity, and Cocaine Dependence Treatment

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

The presence of cocaine metabolites in urine weekly.

Secondary Outcome Measures:

Retention rate and cocaine cravings weekly.

Estimated Enrollment:	120
Study Start Date:	April 2001
Estimated Study Completion Date:	November 2004

Detailed Description:

Cocaine dependence continues to be a significant public health problem, for which there is no FDA approved pharmacotherapy. This study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. The primary outcome measure is benzoylecgonine positive urines. Secondary measures of side effects and craving are also examined.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male and female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence.
female subjects: a negative pregnancy test

Exclusion Criteria:

current or past DSM-IV Axis I disorder other than substance abuse/dependence
any serious non-psychiatric medical illness requiring ongoing medical treatment
substance dependence other than cocaine within the last 3 months
negative urine drug screen for cocaine at time of testing
for female subjects: a positive pregnancy test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297505

Locations

United States, Texas
University of Texas – Houston Health Science Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Frederick G Moeller, M.D.

The University of Texas Health Science Center, Houston

More Information

No publications provided by National Institute on Drug Abuse (NIDA)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Moeller FG, Schmitz JM, Steinberg JL, Green CM, Reist C, Lai LY, Swann AC, Grabowski J. Citalopram combined with behavioral therapy reduces cocaine use: a double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2007;33(3):367-78.

Study ID Numbers:	R01-DA08425
Study First Received:	February 27, 2006
Last Updated:	February 27, 2006
ClinicalTrials.gov Identifier:	NCT00297505 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Cocaine; citalopram; impulsivity; serotonin

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Psychotropic Drugs
Disorders of Environmental Origin
Anesthetics
Cholinergic Agents
Dopamine
Mental Disorders
Substance-Related Disorders
Vasoconstrictor Agents
Antidepressive Agents, Second-Generation
Cocaine

Dexetimide
Antidepressive Agents
Cocaine-Related Disorders
Central Nervous System Depressants
Cardiovascular Agents
Serotonin Uptake Inhibitors
Citalopram
Serotonin
Anesthetics, Local
Muscarinic Antagonists
Dopamine Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Disorders of Environmental Origin
Antiparkinson Agents
Cholinergic Agents
Sensory System Agents
Mental Disorders

Therapeutic Uses
Vasoconstrictor Agents
Substance-Related Disorders
Antidepressive Agents, Second-Generation
Cocaine
Dexetimide
Antidepressive Agents
Cocaine-Related Disorders
Central Nervous System Depressants
Cardiovascular Agents
Citalopram
Serotonin Uptake Inhibitors
Anesthetics, Local
Serotonin
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009