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Citalopram for Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Citalopram

Placebo

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine, citalopram, treatment, serotonin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

UT-Houston Behavioral and Biomedical Sciences Building

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Citalopram low dose

Citalopram high dose

Placebo

Arm Description

Citalopram 20 mg

Citalopram 40 mg

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Retention as Assessed by Number of Participants Remaining in Treatment

Full Information

NCT ID

NCT01535573

First Posted

October 24, 2011

Last Updated

August 29, 2020

Sponsor

Joy Schmitz

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01535573

Brief Title

Citalopram for Cocaine Dependence

Official Title

Clinical Trial of Serotonin Medication Combination in Cocaine Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Joy Schmitz

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence

Keywords

Cocaine, citalopram, treatment, serotonin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Citalopram low dose

Arm Type

Active Comparator

Arm Description

Citalopram 20 mg

Arm Title

Citalopram high dose

Arm Type

Active Comparator

Arm Description

Citalopram 40 mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Citalopram

Intervention Description

20 mg once per day for 9 weeks

Intervention Type

Drug

Intervention Name(s)

Citalopram

Intervention Description

40 mg per day for 9 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

0 mg per day for 9 weeks

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

9 weeks

Secondary Outcome Measure Information:

Title

Proportion of Cocaine-positive Urines Per Week

Description

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.

Time Frame

9 weeks

Title

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

Description

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.

Time Frame

9 weeks

Title

Retention as Assessed by Number of Participants Remaining in Treatment

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joy M Schmitz, Ph.D.

Organizational Affiliation

University of Texas at Houston

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT-Houston Behavioral and Biomedical Sciences Building

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

12. IPD Sharing Statement

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Citalopram for Cocaine Dependence

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