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Citalopram for Cocaine Dependence

This study is currently recruiting participants.
Verified February 2012 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01535573
First received: October 24, 2011
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.


Condition Intervention Phase
Cocaine Dependence
 Drug: Citalopram
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of Serotonin Medication Combination in Cocaine Dependence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Abstinence [ Time Frame: over 9 weeks of treatment ] [ Designated as safety issue: No ]
    The proportion of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (weeks 8-9).


Secondary Outcome Measures:
  • Cocaine Use Days [ Time Frame: over 9 weeks of treatment ] [ Designated as safety issue: No ]
    Weekly fraction of cocaine use days.

  • Cocaine-negative Urines [ Time Frame: over 9 weeks of treatment ] [ Designated as safety issue: No ]
    Percent negative urines collected during treatment period

  • Retention in Treatment [ Time Frame: over 9 weeks of treatment ] [ Designated as safety issue: No ]
    Proportion of subjects remaining in treatment


Estimated Enrollment: 125
Study Start Date: December 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Citalopram low dose
Citalopram 20 mg
 Drug: Citalopram
20 mg once per day for 9 weeks
Active Comparator: Citalopram high dose
Citalopram 40 mg
 Drug: Citalopram
40 mg per day for 9 weeks
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
0 mg per day for 9 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between 18 and 60 years of age
  • meet DSM-IV criteria for current cocaine dependence
  • be in acceptable health on the basis of interview, medical history and physical exam
  • able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria:

  • diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
  • have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
  • medical conditions contraindicating citalopram pharmacotherapy
  • taking medications known to have significant drug interactions with the study medication
  • pregnant or nursing for female patients
  • having plans to leave the immediate geographical area within 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535573

Contacts
Contact: Jessica Vincent, BS 7135003784 Jessica.Vincent@uth.tmc.edu
Contact: Fallon Brewer, BS 7135003784 Fallon.Brewer@uth.tmc.edu

Locations
United States, Texas
UT-Houston Behavioral and Biomedical Sciences Building Recruiting
Houston, Texas, United States, 77054
Contact: Jessica Vincent, BS     713-500-3784     Jessica.Vincent@uth.tmc.edu    
Principal Investigator: Joy M Schmitz, Ph.D.            
Sponsors and Collaborators
Joy Schmitz
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Joy M Schmitz, Ph.D. University of Texas at Houston
  More Information

No publications provided

Responsible Party: Joy Schmitz, Professor , Behavioral Sciences, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01535573     History of Changes
Other Study ID Numbers: 2P50DA009262-16A1
Study First Received: October 24, 2011
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Cocaine
citalopram
treatment
serotonin

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Mental Disorders
Citalopram
Dexetimide
Cocaine
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013