Citalopram for Cocaine Dependence

Joy Schmitz

Status and phase: Completed; Phase 2

Conditions: Cocaine Dependence

Treatments: Drug: Placebo; Drug: Citalopram

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01535573

2P50DA009262-16A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups, including a placebo group

Citalopram low dose

Active Comparator group

Description:

Citalopram 20 mg

Treatment:

Drug: Citalopram

Drug: Citalopram

Citalopram high dose

Active Comparator group

Description:

Citalopram 40 mg

Treatment:

Drug: Citalopram

Drug: Citalopram

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo