Phase 2
N=108
Citalopram for Cocaine Dependence
Cocaine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01535573 ↗Enrolled (actual)
108
Serious AEs
0.9%
Results posted
Aug 2020
Primary outcome: Primary: Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test — 0; 4; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Citalopram (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Joy Schmitz
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test |
0; 4; 2 | — |
| SECONDARY Proportion of Cocaine-positive Urines Per Week |
0.85; 0.8; 0.85 | — |
| SECONDARY Number of Participants With Cocaine-negative Urines Collected During Treatment Period |
14; 26; 27 | — |
| SECONDARY Retention as Assessed by Number of Participants Remaining in Treatment |
13; 23; 24 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01535573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.