Trial Outcomes & Findings for The Efficacy of Doxazosin for Cocaine Users (NCT NCT00880997)
NCT ID: NCT00880997
Last Updated: 2019-08-22
Results Overview
cocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
throughout the study - up to 17 weeks
Results posted on
2019-08-22
Participant Flow
Thirty-five subjects were randomized into the study, with 30 subjects returning and receiving at least one dose of medication.
Participant milestones
| Measure |
Doxazosin Fast
Participantsreaching the target dose after a 4-week titration period
|
Doxazosin Slow
Participants reaching the target dose after an 8-week titration period
|
Placebo
Matching placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
13
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy of Doxazosin for Cocaine Users
Baseline characteristics by cohort
| Measure |
Doxazosin Slow Titration
n=8 Participants
Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
Dox-Slow Group: Participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin over weeks 8-13.
Participants were tapered off doxazosin or placebo over study weeks 14-17.
|
Doxazosin Fast Titration
n=9 Participants
Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
Dox-Fast Group: Participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin over weeks 4-13.
Participants were tapered off doxazosin or placebo over study weeks 14-17.
|
Placebo
n=13 Participants
Participants received matched placebo during weeks 1-13.
Participants were tapered off placebo over study weeks 14-17.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
48.2 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
48 years
STANDARD_DEVIATION 9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
30 participants
n=4 Participants
|
|
Employment
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Alcohol use - past 30 days
|
6.63 days
STANDARD_DEVIATION 3.77 • n=5 Participants
|
10.11 days
STANDARD_DEVIATION 9.55 • n=7 Participants
|
7.85 days
STANDARD_DEVIATION 9.89 • n=5 Participants
|
8.5 days
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Cocaine use - past 30 days
|
18.13 days
STANDARD_DEVIATION 8.90 • n=5 Participants
|
7.89 days
STANDARD_DEVIATION 6.92 • n=7 Participants
|
14.85 days
STANDARD_DEVIATION 10.25 • n=5 Participants
|
15 days
STANDARD_DEVIATION 8.27 • n=4 Participants
|
PRIMARY outcome
Timeframe: throughout the study - up to 17 weekscocaine urine toxicology samples were obtained thrice weekly and tested for the presence of the cocaine metabolite, benzoylecgonine
Outcome measures
| Measure |
DOX-slow Group
n=8 Participants
Participants reaching the target dose after an 8-week titration period are labeled as the DOX slow group. Participants were stabilized on doxazosin over weeks 8-13 and then tapered off doxazosin over study weeks 14-17.
|
DOX-fast Group
n=9 Participants
Participants reaching the target dose after a 4-week period are labeled as the DOX-fast group. Participants were stabilized on doxazosin over weeks 4-13 and then tapered off doxazosin over study weeks 14-17.
|
Placebo
n=13 Participants
Participants took placebo during weeks 1-17.
|
|---|---|---|---|
|
Cocaine Negative Urines
|
10 percentage of cocaine-negative urines
|
35 percentage of cocaine-negative urines
|
14 percentage of cocaine-negative urines
|
SECONDARY outcome
Timeframe: throughout the study - up to 17 weeksPercentage of participants achieving 2 or more consecutive weeks of abstinence
Outcome measures
| Measure |
DOX-slow Group
n=8 Participants
Participants reaching the target dose after an 8-week titration period are labeled as the DOX slow group. Participants were stabilized on doxazosin over weeks 8-13 and then tapered off doxazosin over study weeks 14-17.
|
DOX-fast Group
n=9 Participants
Participants reaching the target dose after a 4-week period are labeled as the DOX-fast group. Participants were stabilized on doxazosin over weeks 4-13 and then tapered off doxazosin over study weeks 14-17.
|
Placebo
n=13 Participants
Participants took placebo during weeks 1-17.
|
|---|---|---|---|
|
Weeks of Abstinence
|
0 percentage of participants
|
44 percentage of participants
|
7 percentage of participants
|
SECONDARY outcome
Timeframe: throughout the study - up to 17 weeksRetention
Outcome measures
| Measure |
DOX-slow Group
n=8 Participants
Participants reaching the target dose after an 8-week titration period are labeled as the DOX slow group. Participants were stabilized on doxazosin over weeks 8-13 and then tapered off doxazosin over study weeks 14-17.
|
DOX-fast Group
n=9 Participants
Participants reaching the target dose after a 4-week period are labeled as the DOX-fast group. Participants were stabilized on doxazosin over weeks 4-13 and then tapered off doxazosin over study weeks 14-17.
|
Placebo
n=13 Participants
Participants took placebo during weeks 1-17.
|
|---|---|---|---|
|
# of Participants That Completed the Study
|
6 Participants
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: throughout study - upto 17 weeksOutcome measures
| Measure |
DOX-slow Group
n=8 Participants
Participants reaching the target dose after an 8-week titration period are labeled as the DOX slow group. Participants were stabilized on doxazosin over weeks 8-13 and then tapered off doxazosin over study weeks 14-17.
|
DOX-fast Group
n=9 Participants
Participants reaching the target dose after a 4-week period are labeled as the DOX-fast group. Participants were stabilized on doxazosin over weeks 4-13 and then tapered off doxazosin over study weeks 14-17.
|
Placebo
n=13 Participants
Participants took placebo during weeks 1-17.
|
|---|---|---|---|
|
Adverse Events
|
26 events
|
9 events
|
23 events
|
Adverse Events
Dox-Slow Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dox-Fast Group:
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dox-Slow Group
n=8 participants at risk
Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)
|
Dox-Fast Group:
n=9 participants at risk
Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
|
Placebo
n=13 participants at risk
A sugar pill to mimic the experiment drug, doxazosin, will be administered in the same manner as the experimental drug through the study duration.
Placebo: Placebo daily dosing
|
|---|---|---|---|
|
Nervous system disorders
Headaches
|
25.0%
2/8 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
11.1%
1/9 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
23.1%
3/13 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
|
Cardiac disorders
Dizinness
|
0.00%
0/8 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
22.2%
2/9 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
0.00%
0/13 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
|
General disorders
Toothache
|
12.5%
1/8 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
11.1%
1/9 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
0.00%
0/13 • Adverse events were collected over the entire study duration for all patients, up to 17 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place