Trial Outcomes & Findings for Citalopram for Cocaine Dependence (NCT NCT01535573)
NCT ID: NCT01535573
Last Updated: 2020-09-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
9 weeks
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Citalopram Low Dose
Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks
|
Citalopram High Dose
Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks
|
Placebo
Placebo
Placebo: 0 mg per day for 9 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
44
|
43
|
|
Overall Study
COMPLETED
|
13
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
8
|
21
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Citalopram for Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Citalopram Low Dose
n=21 Participants
Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks
|
Citalopram High Dose
n=44 Participants
Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks
|
Placebo
n=43 Participants
Placebo
Placebo: 0 mg per day for 9 weeks
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
46.905 years
STANDARD_DEVIATION 7.578 • n=93 Participants
|
44.477 years
STANDARD_DEVIATION 9.488 • n=4 Participants
|
47.116 years
STANDARD_DEVIATION 8.724 • n=27 Participants
|
46.000 years
STANDARD_DEVIATION 8.846 • n=483 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
89 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
44 participants
n=4 Participants
|
43 participants
n=27 Participants
|
108 participants
n=483 Participants
|
|
Number of Years of Education
|
12.571 years
STANDARD_DEVIATION 2.216 • n=93 Participants
|
12.045 years
STANDARD_DEVIATION 1.796 • n=4 Participants
|
12.488 years
STANDARD_DEVIATION 1.921 • n=27 Participants
|
12.324 years
STANDARD_DEVIATION 1.932 • n=483 Participants
|
|
Number of Days of Cocaine Use in Past 30 Days
|
12.238 days
STANDARD_DEVIATION 2.216 • n=93 Participants
|
17.114 days
STANDARD_DEVIATION 9.163 • n=4 Participants
|
14.465 days
STANDARD_DEVIATION 9.815 • n=27 Participants
|
15.111 days
STANDARD_DEVIATION 8.594 • n=483 Participants
|
PRIMARY outcome
Timeframe: 9 weeksUrine 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.
Outcome measures
| Measure |
Citalopram Low Dose
n=21 Participants
Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks
|
Citalopram High Dose
n=44 Participants
Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks
|
Placebo
n=43 Participants
Placebo
Placebo: 0 mg per day for 9 weeks
|
|---|---|---|---|
|
Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
|
0 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 9 weeksMean 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.
Outcome measures
| Measure |
Citalopram Low Dose
n=21 Participants
Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks
|
Citalopram High Dose
n=44 Participants
Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks
|
Placebo
n=43 Participants
Placebo
Placebo: 0 mg per day for 9 weeks
|
|---|---|---|---|
|
Proportion of Cocaine-positive Urines Per Week
|
0.85 proportion of cocaine urines per week
Standard Deviation 0.23
|
0.8 proportion of cocaine urines per week
Standard Deviation 0.3
|
0.85 proportion of cocaine urines per week
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: 9 weeksUrine 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.
Outcome measures
| Measure |
Citalopram Low Dose
n=21 Participants
Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks
|
Citalopram High Dose
n=44 Participants
Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks
|
Placebo
n=43 Participants
Placebo
Placebo: 0 mg per day for 9 weeks
|
|---|---|---|---|
|
Number of Participants With Cocaine-negative Urines Collected During Treatment Period
|
14 Participants
|
26 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 9 weeksOutcome measures
| Measure |
Citalopram Low Dose
n=21 Participants
Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks
|
Citalopram High Dose
n=44 Participants
Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks
|
Placebo
n=43 Participants
Placebo
Placebo: 0 mg per day for 9 weeks
|
|---|---|---|---|
|
Retention as Assessed by Number of Participants Remaining in Treatment
|
13 Participants
|
23 Participants
|
24 Participants
|
Adverse Events
Citalopram Low Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Citalopram High Dose
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Citalopram Low Dose
n=21 participants at risk
Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks
|
Citalopram High Dose
n=44 participants at risk
Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks
|
Placebo
n=43 participants at risk
Placebo
Placebo: 0 mg per day for 9 weeks
|
|---|---|---|---|
|
Psychiatric disorders
Hospitalization for Suicidal Ideation
|
0.00%
0/21 • 9 weeks
|
0.00%
0/44 • 9 weeks
|
2.3%
1/43 • Number of events 1 • 9 weeks
|
Other adverse events
| Measure |
Citalopram Low Dose
n=21 participants at risk
Citalopram 20 mg
Citalopram: 20 mg once per day for 9 weeks
|
Citalopram High Dose
n=44 participants at risk
Citalopram 40 mg
Citalopram: 40 mg per day for 9 weeks
|
Placebo
n=43 participants at risk
Placebo
Placebo: 0 mg per day for 9 weeks
|
|---|---|---|---|
|
Cardiac disorders
Elevated Blood Pressure
|
0.00%
0/21 • 9 weeks
|
0.00%
0/44 • 9 weeks
|
2.3%
1/43 • Number of events 1 • 9 weeks
|
|
Cardiac disorders
Abnormal electrocardiogram (EKG)
|
0.00%
0/21 • 9 weeks
|
2.3%
1/44 • Number of events 1 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
General disorders
Drowsiness
|
0.00%
0/21 • 9 weeks
|
2.3%
1/44 • Number of events 1 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
General disorders
Not Sleeping Well
|
9.5%
2/21 • Number of events 2 • 9 weeks
|
2.3%
1/44 • Number of events 4 • 9 weeks
|
9.3%
4/43 • Number of events 8 • 9 weeks
|
|
General disorders
Headache
|
0.00%
0/21 • 9 weeks
|
4.5%
2/44 • Number of events 2 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
General disorders
Nervousness
|
0.00%
0/21 • 9 weeks
|
0.00%
0/44 • 9 weeks
|
2.3%
1/43 • Number of events 1 • 9 weeks
|
|
Eye disorders
Blurry Vision
|
0.00%
0/21 • 9 weeks
|
2.3%
1/44 • Number of events 1 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/21 • 9 weeks
|
4.5%
2/44 • Number of events 2 • 9 weeks
|
2.3%
1/43 • Number of events 1 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/21 • 9 weeks
|
0.00%
0/44 • 9 weeks
|
2.3%
1/43 • Number of events 1 • 9 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 1 • 9 weeks
|
2.3%
1/44 • Number of events 1 • 9 weeks
|
4.7%
2/43 • Number of events 2 • 9 weeks
|
|
Renal and urinary disorders
Increased Urination
|
9.5%
2/21 • Number of events 2 • 9 weeks
|
0.00%
0/44 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
General disorders
Change in Sexual Function
|
0.00%
0/21 • 9 weeks
|
4.5%
2/44 • Number of events 3 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
General disorders
Sweating
|
4.8%
1/21 • Number of events 1 • 9 weeks
|
4.5%
2/44 • Number of events 2 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • 9 weeks
|
2.3%
1/44 • Number of events 1 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
Musculoskeletal and connective tissue disorders
Difficulty Walking
|
4.8%
1/21 • Number of events 2 • 9 weeks
|
2.3%
1/44 • Number of events 1 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
General disorders
Loss of Appetite
|
4.8%
1/21 • Number of events 1 • 9 weeks
|
9.1%
4/44 • Number of events 6 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
|
General disorders
Confusion
|
0.00%
0/21 • 9 weeks
|
2.3%
1/44 • Number of events 1 • 9 weeks
|
0.00%
0/43 • 9 weeks
|
Additional Information
Joy M. Schmitz, PhD, Professor and Director of Center For Neurobehavioral Research On Addictions
The University of Texas Health Science Center at Houston
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place