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.

Study Overview

• Status: Completed
• Conditions: Cocaine Dependence
• Intervention / Treatment: Drug: Citalopram; Drug: Citalopram; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 0 mg per day for 9 weeks
Active Comparator: Citalopram low dose; Citalopram 20 mg	Drug: Citalopram; 20 mg once per day for 9 weeks; Drug: Citalopram; 40 mg per day for 9 weeks
Active Comparator: Citalopram high dose; Citalopram 40 mg	Drug: Citalopram; 20 mg once per day for 9 weeks; Drug: Citalopram; 40 mg per day for 9 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test	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.	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Cocaine-positive Urines Per Week	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.	9 weeks
Number of Participants With Cocaine-negative Urines Collected During Treatment Period	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.	9 weeks
Retention as Assessed by Number of Participants Remaining in Treatment		9 weeks

Collaborators and Investigators

• Sponsor: Joy Schmitz
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Joy M Schmitz, Ph.D., University of Texas at Houston

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (Estimate): February 17, 2012

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: August 29, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: treatment; Cocaine; serotonin; citalopram
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Citalopram; Dexetimide
• Other Study ID Numbers: 2P50DA009262-16A1 (U.S. NIH Grant/Contract)