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Citalopram for Cocaine Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01535573
First Posted: February 17, 2012
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Joy Schmitz, The University of Texas Health Science Center, Houston
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of Serotonin Medication Combination in Cocaine Dependence

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 122
Study Start Date: December 2010
Study Completion Date: July 2016
Primary Completion Date: July 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535573


Locations
United States, Texas
UT-Houston Behavioral and Biomedical Sciences Building
Houston, Texas, United States, 77054
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

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 ( U.S. NIH Grant/Contract )
First Submitted: October 24, 2011
First Posted: February 17, 2012
Last Update Posted: May 4, 2017
Last Verified: May 2017

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

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Citalopram
Serotonin
Dexetimide
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Serotonin Receptor Agonists
Serotonin Agents
Serotonin Uptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics