Trial Outcomes & Findings for Pharmacogenetics of Doxazosin for Cocaine Dependence (NCT NCT01145183)
NCT ID: NCT01145183
Last Updated: 2019-07-22
Results Overview
Cocaine positive urines
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
2 weeks blocks throughout study
Results posted on
2019-07-22
Participant Flow
A total of 201 individuals seeking treatment for cocaine dependence were screened between October 2009 and September 2013 at the Outpatient Clinical Trials Research Clinic at MEDVAMC. 16 participants were excluded because they did not meet the inclusion criteria, and 89 participants were lost to follow up before randomization into this study.
Thus, 96 individuals entered into the study and were randomly assigned into the doxazosin or the placebo groups. Following randomization, 7 participants were lost to follow up and 13 opted out of the pharmacogenetic testing. In total, 76 CUD patients participated in this trial.
Participant milestones
| Measure |
Doxazosin (AA Genotype)
A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
|
Doxazosin (AT/TT Genotype)
A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
|
Placebo (AA Genotype)
Matched placebo daily dosing
|
Placebo (AT/TT Genotype)
Matched placebo daily dosing
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
26
|
19
|
10
|
|
Overall Study
COMPLETED
|
21
|
26
|
19
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacogenetics of Doxazosin for Cocaine Dependence
Baseline characteristics by cohort
| Measure |
Doxazosin (AA Genotype)
n=21 Participants
A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
|
Doxazosin (AT/TT Genotype)
n=26 Participants
A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
|
Placebo (AA Genotype)
n=19 Participants
Matched placebo daily dosing
|
Placebo (AT/TT Genotype)
n=10 Participants
Matched placebo daily dosing
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 6 • n=99 Participants
|
48.9 years
STANDARD_DEVIATION 10.2 • n=107 Participants
|
46.6 years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
48.8 years
STANDARD_DEVIATION 6 • n=7 Participants
|
48 years
STANDARD_DEVIATION 7.8 • n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
56 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
26 participants
n=107 Participants
|
19 participants
n=206 Participants
|
10 participants
n=7 Participants
|
76 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 2 weeks blocks throughout studyCocaine positive urines
Outcome measures
| Measure |
Doxazosin (AA Genotype)
n=21 Participants
A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
|
Doxazosin (AT/TT Genotype)
n=26 Participants
A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
|
Placebo (AA Genotype)
n=19 Participants
Matched placebo daily dosing
|
Placebo (AT/TT Genotype)
n=10 Participants
Matched placebo daily dosing
|
|---|---|---|---|---|
|
Percentage of Cocaine Positive Urine Toxicology
Weeks 1-2
|
88.6 percentage of positive urines
|
85.6 percentage of positive urines
|
75.7 percentage of positive urines
|
75.9 percentage of positive urines
|
|
Percentage of Cocaine Positive Urine Toxicology
Weeks 3-4
|
88.6 percentage of positive urines
|
84.7 percentage of positive urines
|
82.8 percentage of positive urines
|
84.7 percentage of positive urines
|
|
Percentage of Cocaine Positive Urine Toxicology
Weeks 5-6
|
84.9 percentage of positive urines
|
68.0 percentage of positive urines
|
84.9 percentage of positive urines
|
95.7 percentage of positive urines
|
|
Percentage of Cocaine Positive Urine Toxicology
Weeks 7-8
|
75.5 percentage of positive urines
|
70.3 percentage of positive urines
|
77.2 percentage of positive urines
|
100.0 percentage of positive urines
|
|
Percentage of Cocaine Positive Urine Toxicology
Weeks 9-10
|
86.3 percentage of positive urines
|
61.9 percentage of positive urines
|
80.6 percentage of positive urines
|
97.0 percentage of positive urines
|
|
Percentage of Cocaine Positive Urine Toxicology
Weeks 11-12
|
82.8 percentage of positive urines
|
67.3 percentage of positive urines
|
81.2 percentage of positive urines
|
100.0 percentage of positive urines
|
SECONDARY outcome
Timeframe: Pre- and post study medicationAdverse effects were closely monitored during each clinic visit throughout this trial. Vital signs including blood pressure (both pre-medication and post-medication) were measured and documented as were concomitant medications.
Outcome measures
| Measure |
Doxazosin (AA Genotype)
n=47 Participants
A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
|
Doxazosin (AT/TT Genotype)
n=29 Participants
A single dose of doxazosin (8 mg/day) was used in the active medication arm with titration up to 8 mg occurring over a 2-week period.
|
Placebo (AA Genotype)
Matched placebo daily dosing
|
Placebo (AT/TT Genotype)
Matched placebo daily dosing
|
|---|---|---|---|---|
|
Adverse Events
|
0 events
|
0 events
|
—
|
—
|
Adverse Events
Doxazosin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place