Cocaine Dependence | Citalopram for Cocaine Dependence
Cocaine Dependence research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Citalopram20 mg once per day for 9 weeks
Drug:Citalopram40 mg per day for 9 weeks
Drug:Placebo0 mg per day for 9 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Citalopram low doseCitalopram 20 mg
Citalopram high doseCitalopram 40 mg
Start Date: December 2010
Completed Date: July 2016
Phase: Phase 2
Primary Outcome: Abstinence
Secondary Outcome: Cocaine Use Days
Study sponsors, principal investigator, and references
Principal Investigator: Joy M Schmitz, Ph.D.
Lead Sponsor: Joy Schmitz
Collaborator: National Institute on Drug Abuse (NIDA)