Trial Outcomes & Findings for Cocaine Withdrawal and Pharmacotherapy Response (NCT NCT00566969)
NCT ID: NCT00566969
Last Updated: 2020-04-02
Results Overview
Percent Self reported days of abstinence from any cocaine use during the 11 week trial.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
106 participants
Primary outcome timeframe
11 weeks
Results posted on
2020-04-02
Participant Flow
Participant milestones
| Measure |
Sugar Pill
To be compared to active drug
sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator
|
Carvedilol 25 mg
To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
|
Carvedilol 50 mg
To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
37
|
35
|
|
Overall Study
COMPLETED
|
19
|
28
|
23
|
|
Overall Study
NOT COMPLETED
|
15
|
9
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cocaine Withdrawal and Pharmacotherapy Response
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=34 Participants
To be compared to active drug
sugar pill: Subjects randomized to placebo, carvedilol 25mg or 50mg
|
Carvedilol 25 mg
n=37 Participants
To be compared to placebo and Carvedilol 50 mg
carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg
|
Carvedilol 50 mg
n=35 Participants
To be compared to placebo and Carvedilol 25 mg
Carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.6 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
39.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
38.1 years
STANDARD_DEVIATION 10.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
66 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
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
70 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 11 weeksPercent Self reported days of abstinence from any cocaine use during the 11 week trial.
Outcome measures
| Measure |
Sugar Pill
n=19 Participants
To be compared to active drug
sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator
|
Carvedilol 25 mg
n=28 Participants
To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
|
Carvedilol 50 mg
n=23 Participants
To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
|
|---|---|---|---|
|
Percent Days Abstinent From Cocaine - Self Report
|
72.9 percentage of days
Standard Deviation 25.3
|
72.9 percentage of days
Standard Deviation 29
|
59.3 percentage of days
Standard Deviation 31.7
|
Adverse Events
Sugar Pill
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Carvedilol 25 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Carvedilol 50 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugar Pill
n=19 participants at risk
To be compared to active drug
sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator
|
Carvedilol 25 mg
n=28 participants at risk
To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
|
Carvedilol 50 mg
n=23 participants at risk
To be compared to sugar pill
carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight.
|
|---|---|---|---|
|
Psychiatric disorders
Disturbed concentration
|
31.6%
6/19 • Number of events 6 • 5 years
|
17.9%
5/28 • Number of events 5 • 5 years
|
30.4%
7/23 • Number of events 7 • 5 years
|
|
Psychiatric disorders
Agitation
|
57.9%
11/19 • Number of events 11 • 5 years
|
46.4%
13/28 • Number of events 13 • 5 years
|
30.4%
7/23 • Number of events 7 • 5 years
|
|
Psychiatric disorders
Tiredness
|
68.4%
13/19 • Number of events 13 • 5 years
|
46.4%
13/28 • Number of events 13 • 5 years
|
47.8%
11/23 • Number of events 11 • 5 years
|
|
Psychiatric disorders
Drowsiness
|
31.6%
6/19 • Number of events 6 • 5 years
|
35.7%
10/28 • Number of events 10 • 5 years
|
30.4%
7/23 • Number of events 7 • 5 years
|
|
Psychiatric disorders
Insomnia
|
73.7%
14/19 • Number of events 14 • 5 years
|
46.4%
13/28 • Number of events 13 • 5 years
|
47.8%
11/23 • Number of events 11 • 5 years
|
|
Psychiatric disorders
Nightmares
|
26.3%
5/19 • Number of events 5 • 5 years
|
17.9%
5/28 • Number of events 5 • 5 years
|
30.4%
7/23 • Number of events 7 • 5 years
|
|
Psychiatric disorders
Depression
|
52.6%
10/19 • Number of events 10 • 5 years
|
39.3%
11/28 • Number of events 11 • 5 years
|
47.8%
11/23 • Number of events 11 • 5 years
|
|
Psychiatric disorders
Anxiety
|
42.1%
8/19 • Number of events 8 • 5 years
|
35.7%
10/28 • Number of events 10 • 5 years
|
47.8%
11/23 • Number of events 11 • 5 years
|
|
Nervous system disorders
Numbness
|
15.8%
3/19 • Number of events 3 • 5 years
|
25.0%
7/28 • Number of events 7 • 5 years
|
30.4%
7/23 • Number of events 7 • 5 years
|
|
Nervous system disorders
Cramps
|
21.1%
4/19 • Number of events 4 • 5 years
|
14.3%
4/28 • Number of events 4 • 5 years
|
17.4%
4/23 • Number of events 4 • 5 years
|
|
Nervous system disorders
Headache
|
36.8%
7/19 • Number of events 7 • 5 years
|
32.1%
9/28 • Number of events 9 • 5 years
|
34.8%
8/23 • Number of events 8 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
68.4%
13/19 • Number of events 13 • 5 years
|
39.3%
11/28 • Number of events 11 • 5 years
|
56.5%
13/23 • Number of events 13 • 5 years
|
|
Gastrointestinal disorders
Decreased appetitie
|
31.6%
6/19 • Number of events 6 • 5 years
|
25.0%
7/28 • Number of events 7 • 5 years
|
17.4%
4/23 • Number of events 4 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place