Cocaine Dependence
Conditions
Keywords
Cocaine, citalopram, treatment, serotonin
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.
Interventions
DRUGCitalopram
20 mg once per day for 9 weeks
DRUGPlacebo
0 mg per day for 9 weeks
Sponsors
National Institute on Drug Abuse (NIDA)
Joy Schmitz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test | 9 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Cocaine-positive Urines Per Week | 9 weeks | 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 | 9 weeks | 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 | 9 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Citalopram Low Dose Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks | 21 |
| Citalopram High Dose Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks | 44 |
| Placebo Placebo
Placebo: 0 mg per day for 9 weeks | 43 |
| Total | 108 |
Baseline characteristics
| Characteristic | Citalopram Low Dose | Citalopram High Dose | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 46.905 years STANDARD_DEVIATION 7.578 | 44.477 years STANDARD_DEVIATION 9.488 | 47.116 years STANDARD_DEVIATION 8.724 | 46.000 years STANDARD_DEVIATION 8.846 |
| Number of Days of Cocaine Use in Past 30 Days | 12.238 days STANDARD_DEVIATION 2.216 | 17.114 days STANDARD_DEVIATION 9.163 | 14.465 days STANDARD_DEVIATION 9.815 | 15.111 days STANDARD_DEVIATION 8.594 |
| Number of Years of Education | 12.571 years STANDARD_DEVIATION 2.216 | 12.045 years STANDARD_DEVIATION 1.796 | 12.488 years STANDARD_DEVIATION 1.921 | 12.324 years STANDARD_DEVIATION 1.932 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 18 Participants | 32 Participants | 31 Participants | 81 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 5 Participants | 5 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 1 Participants | 6 Participants | 7 Participants | 14 Participants |
| Region of Enrollment United States | 21 participants | 44 participants | 43 participants | 108 participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 8 Participants | 19 Participants |
| Sex: Female, Male Male | 18 Participants | 36 Participants | 35 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 44 | 0 / 43 |
| other Total, other adverse events | 9 / 21 | 20 / 44 | 10 / 43 |
| serious Total, serious adverse events | 0 / 21 | 0 / 44 | 1 / 43 |
Outcome results
Primary
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.
Time frame: 9 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Citalopram Low Dose | Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test | 0 Participants |
| Citalopram High Dose | Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test | 4 Participants |
| Placebo | Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test | 2 Participants |
Secondary
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.
Time frame: 9 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Citalopram Low Dose | Number of Participants With Cocaine-negative Urines Collected During Treatment Period | 14 Participants |
| Citalopram High Dose | Number of Participants With Cocaine-negative Urines Collected During Treatment Period | 26 Participants |
| Placebo | Number of Participants With Cocaine-negative Urines Collected During Treatment Period | 27 Participants |
Secondary
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.
Time frame: 9 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Citalopram Low Dose | Proportion of Cocaine-positive Urines Per Week | 0.85 proportion of cocaine urines per week | Standard Deviation 0.23 |
| Citalopram High Dose | Proportion of Cocaine-positive Urines Per Week | 0.8 proportion of cocaine urines per week | Standard Deviation 0.3 |
| Placebo | Proportion of Cocaine-positive Urines Per Week | 0.85 proportion of cocaine urines per week | Standard Deviation 0.25 |
Secondary
Retention as Assessed by Number of Participants Remaining in Treatment
Time frame: 9 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Citalopram Low Dose | Retention as Assessed by Number of Participants Remaining in Treatment | 13 Participants |
| Citalopram High Dose | Retention as Assessed by Number of Participants Remaining in Treatment | 23 Participants |
| Placebo | Retention as Assessed by Number of Participants Remaining in Treatment | 24 Participants |