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Serotonin, Impulsivity, and Cocaine Dependence Treatment

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00297505
First received: February 27, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Serotonin, Impulsivity, and Cocaine Dependence Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine; citalopram; impulsivity; serotonin

Additional relevant MeSH terms:
Cocaine-Related Disorders
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Citalopram
Cocaine
Dexetimide
Serotonin
Anesthetics
Anesthetics, Local
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Cholinergic Agents
Cholinergic Antagonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014