Citalopram for Cocaine Dependence

NCT ID: NCT01535573

Last Updated: 2020-09-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Citalopram low dose

Citalopram 20 mg

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

20 mg once per day for 9 weeks

Citalopram high dose

Citalopram 40 mg

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

40 mg per day for 9 weeks

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg per day for 9 weeks

Interventions

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Citalopram

20 mg once per day for 9 weeks

Intervention Type DRUG

Citalopram

40 mg per day for 9 weeks

Intervention Type DRUG

Placebo

0 mg per day for 9 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Joy Schmitz

OTHER

Sponsor Role lead

Responsible Party

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Joy Schmitz

Professor , Behavioral Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joy M Schmitz, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Houston

Locations

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UT-Houston Behavioral and Biomedical Sciences Building

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2P50DA009262-16A1

Identifier Type: NIH

Identifier Source: secondary_id

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2P50DA009262-16A1

Identifier Type: NIH

Identifier Source: org_study_id

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