Trial Outcomes & Findings for Carvedilol for Psychostimulant Dependence (NCT NCT01171183)
NCT ID: NCT01171183
Last Updated: 2015-07-31
Results Overview
Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
based on thrice weekly urine results during the 10-week outpatient phase
Results posted on
2015-07-31
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo
|
Carvedilol Controlled Release
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
|
|---|---|---|
|
Residential Facility (Weeks 1-2)
STARTED
|
15
|
16
|
|
Residential Facility (Weeks 1-2)
COMPLETED
|
13
|
10
|
|
Residential Facility (Weeks 1-2)
NOT COMPLETED
|
2
|
6
|
|
Outpatient Participation (Weeks 3-10)
STARTED
|
12
|
9
|
|
Outpatient Participation (Weeks 3-10)
COMPLETED
|
2
|
4
|
|
Outpatient Participation (Weeks 3-10)
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: Placebo
|
Carvedilol Controlled Release
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
|
|---|---|---|
|
Residential Facility (Weeks 1-2)
Withdrawal by Subject
|
2
|
2
|
|
Residential Facility (Weeks 1-2)
Protocol Violation
|
0
|
1
|
|
Residential Facility (Weeks 1-2)
BP outside of study parameters
|
0
|
3
|
|
Outpatient Participation (Weeks 3-10)
Withdrawal by Subject
|
2
|
2
|
|
Outpatient Participation (Weeks 3-10)
Lost to Follow-up
|
7
|
3
|
|
Outpatient Participation (Weeks 3-10)
Use of contraindicated med: PI term
|
1
|
0
|
Baseline Characteristics
Carvedilol for Psychostimulant Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=15 Participants
Placebo: Placebo
|
Carvedilol Controlled Release
n=15 Participants
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: based on thrice weekly urine results during the 10-week outpatient phasePopulation: Those who completed the residential facility and attended at least one outpatient clinic visit to complete assessments.
Treatment Effectiveness Score, defined by the # of cocaine negative urines during the outpatient phase of the study divided by the total number of urine samples (30) and then multiplied by 100.
Outcome measures
| Measure |
Placebo
n=12 Participants
Placebo: Placebo
|
Carvedilol Controlled Release
n=9 Participants
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
|
|---|---|---|
|
Urine Toxicology Screens
|
38.33 percentage of cocaine negative urines
Standard Deviation 35.23
|
41.85 percentage of cocaine negative urines
Standard Deviation 40.73
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Those eligible participants who entered the residential facility and received at least one dose of study medication. One person in the carvedilol group is excluded from all analyses due to not meeting inclusion criteria.
number of weeks each participant is on study protocol
Outcome measures
| Measure |
Placebo
n=15 Participants
Placebo: Placebo
|
Carvedilol Controlled Release
n=15 Participants
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
|
|---|---|---|
|
Retention
|
5.70 Weeks
Standard Deviation 4.04
|
5.28 Weeks
Standard Deviation 5.00
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Carvedilol Controlled Release
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=15 participants at risk
Placebo: Placebo
|
Carvedilol Controlled Release
n=15 participants at risk
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Severe disabling hip pain
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
Other adverse events
| Measure |
Placebo
n=15 participants at risk
Placebo: Placebo
|
Carvedilol Controlled Release
n=15 participants at risk
controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
|
|---|---|---|
|
Vascular disorders
lightheaded/dizzy
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
20.0%
3/15 • Number of events 4 • during the 12 week trial as well as during the taper period
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
13.3%
2/15 • Number of events 2 • during the 12 week trial as well as during the taper period
|
|
Nervous system disorders
sleep disturbances
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
13.3%
2/15 • Number of events 2 • during the 12 week trial as well as during the taper period
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
13.3%
2/15 • Number of events 2 • during the 12 week trial as well as during the taper period
|
|
Reproductive system and breast disorders
vaginal yeast infection
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Nervous system disorders
Headache
|
20.0%
3/15 • Number of events 3 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Nervous system disorders
cold hand, tingling fingers
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
Renal and urinary disorders
Penile discharge, burning
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
Renal and urinary disorders
Night Sweats
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Respiratory, thoracic and mediastinal disorders
cold symptoms
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Number of events 2 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Gastrointestinal disorders
nausea/vomiting and/or diarrhea
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
13.3%
2/15 • Number of events 2 • during the 12 week trial as well as during the taper period
|
|
Immune system disorders
flu-like symptoms
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Musculoskeletal and connective tissue disorders
burned hand
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Eye disorders
swollen eye
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Nervous system disorders
numbness in hand
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
General disorders
tiredness, lethargic
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Psychiatric disorders
Anxious, restless
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Number of events 2 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
13.3%
2/15 • Number of events 2 • during the 12 week trial as well as during the taper period
|
|
General disorders
Fell down
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Musculoskeletal and connective tissue disorders
Sharp pain upper left torso
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
Psychiatric disorders
Feeling "high"
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
Psychiatric disorders
Paranoid delusions
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
Renal and urinary disorders
Frequent urination
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
Skin and subcutaneous tissue disorders
Insect bite
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
|
Cardiac disorders
Elevated blood pressure
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
|
Cardiac disorders
Hypotension
|
0.00%
0/15 • during the 12 week trial as well as during the taper period
|
6.7%
1/15 • Number of events 1 • during the 12 week trial as well as during the taper period
|
Additional Information
Alison Oliveto, PhD
University of Arkansas for Medical Sciences
Phone: 501-526-8441
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place