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Citalopram for Cocaine Dependence

This study has been completed.
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: May 3, 2017
Last verified: May 2017
October 24, 2011
May 3, 2017
December 2010
July 2016   (Final data collection date for primary outcome measure)
Abstinence [ Time Frame: over 9 weeks of treatment ]
The proportion of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (weeks 8-9).
Same as current
Complete list of historical versions of study NCT01535573 on ClinicalTrials.gov Archive Site
  • Cocaine Use Days [ Time Frame: over 9 weeks of treatment ]
    Weekly fraction of cocaine use days.
  • Cocaine-negative Urines [ Time Frame: over 9 weeks of treatment ]
    Percent negative urines collected during treatment period
  • Retention in Treatment [ Time Frame: over 9 weeks of treatment ]
    Proportion of subjects remaining in treatment
Same as current
Not Provided
Not Provided
 
Citalopram for Cocaine Dependence
Clinical Trial of Serotonin Medication Combination in Cocaine Dependence
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Cocaine Dependence
  • Drug: Citalopram
    20 mg once per day for 9 weeks
  • Drug: Citalopram
    40 mg per day for 9 weeks
  • Drug: Placebo
    0 mg per day for 9 weeks
  • Active Comparator: Citalopram low dose
    Citalopram 20 mg
    Intervention: Drug: Citalopram
  • Active Comparator: Citalopram high dose
    Citalopram 40 mg
    Intervention: Drug: Citalopram
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122
July 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • between 18 and 60 years of age
  • meet Diagnostic and Statistical Manual 4 (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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01535573
2P50DA009262-16A1( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Joy Schmitz, The University of Texas Health Science Center, Houston
Joy Schmitz
National Institute on Drug Abuse (NIDA)
Principal Investigator: Joy M Schmitz, Ph.D. University of Texas at Houston
The University of Texas Health Science Center, Houston
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP