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Completed

NCT Number: NCT01535573

Citalopram for 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.

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UT-Houston Behavioral and Biomedical Sciences Building

Houston, Texas, 77054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Citalopram

Drug

20 mg once per day for 9 weeks

Placebo

Drug

0 mg per day for 9 weeks

Primary outcomes

  1. Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test

    Time frame: 9 weeks

    Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.

Secondary outcomes

  1. Proportion of Cocaine-positive Urines Per Week

    Time frame: 9 weeks

    Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use.

  2. Number of Participants With Cocaine-negative Urines Collected During Treatment Period

    Time frame: 9 weeks

    Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.

  3. Retention as Assessed by Number of Participants Remaining in Treatment

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

Joy Schmitz

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Clinical Trial of Serotonin Medication Combination in Cocaine Dependence

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 17, 2012
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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