Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Citalopram for Cocaine Dependence

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 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: January 4, 2016
Last verified: January 2016
  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:


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 Study Completion Date: November 2016
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
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: NCT01535573

Contacts
Contact: Jessica Vincent 713-500-3784 Jessica.Vincent@uth.tmc.edu
Contact: Rolanda Johnson 713-486-2639 Rolanda.Johnson@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

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: January 4, 2016
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
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

ClinicalTrials.gov processed this record on December 05, 2016