Trial Outcomes & Findings for Doxazosin for Psychostimulant Dependence (NCT NCT01371851)
NCT ID: NCT01371851
Last Updated: 2015-07-27
Results Overview
Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
twice-weekly urine samples (8 weeks)
Results posted on
2015-07-27
Participant Flow
Participant milestones
| Measure |
Doxazosin
Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
Placebo
Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Doxazosin
Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
Placebo
Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
|
Overall Study
was arrested and put in jail
|
0
|
1
|
|
Overall Study
non study related adverse event
|
1
|
0
|
|
Overall Study
Blood Pressure outside study parameters
|
2
|
0
|
Baseline Characteristics
Doxazosin for Psychostimulant Dependence
Baseline characteristics by cohort
| Measure |
Doxazosin
n=11 Participants
Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
Placebo
n=11 Participants
Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
Total
n=22 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
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 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
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 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
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 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
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: twice-weekly urine samples (8 weeks)Population: Those eligible participants who received at least one dose of study medication.
Urine samples positive for methamphetamine or cocaine via twice-weekly urine drug screens. Weekly urine results data were averaged within subjects and the mean proportion across subjects within each group was calculated for graphic representation.
Outcome measures
| Measure |
Doxazosin
n=89 Urine samples
Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
Placebo
n=77 Urine samples
Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
|---|---|---|
|
Change in Psychostimulant-positive Urines Over Time
Week 1 (N=10, 11)
|
.6 proportion of psychostimulant-pos urines
Standard Deviation .52
|
.41 proportion of psychostimulant-pos urines
Standard Deviation .49
|
|
Change in Psychostimulant-positive Urines Over Time
Week 2 (N=7, 8)
|
.79 proportion of psychostimulant-pos urines
Standard Deviation .39
|
.25 proportion of psychostimulant-pos urines
Standard Deviation .38
|
|
Change in Psychostimulant-positive Urines Over Time
Week 3 (N=6, 5)
|
.58 proportion of psychostimulant-pos urines
Standard Deviation .49
|
.4 proportion of psychostimulant-pos urines
Standard Deviation .55
|
|
Change in Psychostimulant-positive Urines Over Time
Week 4 (N=6, 4)
|
.75 proportion of psychostimulant-pos urines
Standard Deviation .42
|
.5 proportion of psychostimulant-pos urines
Standard Deviation .58
|
|
Change in Psychostimulant-positive Urines Over Time
Week 5 (N=4, 4)
|
.5 proportion of psychostimulant-pos urines
Standard Deviation .41
|
.25 proportion of psychostimulant-pos urines
Standard Deviation .29
|
|
Change in Psychostimulant-positive Urines Over Time
Week 6 (N=4, 3)
|
.63 proportion of psychostimulant-pos urines
Standard Deviation .25
|
0 proportion of psychostimulant-pos urines
Standard Deviation 0
|
|
Change in Psychostimulant-positive Urines Over Time
Week 7 (N=4, 3)
|
1 proportion of psychostimulant-pos urines
Standard Deviation 0
|
0 proportion of psychostimulant-pos urines
Standard Deviation 0
|
|
Change in Psychostimulant-positive Urines Over Time
Week 8 (N=3, 2)
|
.83 proportion of psychostimulant-pos urines
Standard Deviation .29
|
.25 proportion of psychostimulant-pos urines
Standard Deviation .35
|
Adverse Events
Doxazosin
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxazosin
n=11 participants at risk
Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
Placebo
n=11 participants at risk
Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
Other adverse events
| Measure |
Doxazosin
n=11 participants at risk
Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
Placebo
n=11 participants at risk
Participants will be maintained on placebo (cellulose) throughout the trial.
Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Numbness in fingertips
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
nausea, abdominal cramps
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
black eye
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Psychiatric disorders
palpitations with shortness of breath
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Drowsiness, Fatigue
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Sweating
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Blood and lymphatic system disorders
Head edema from fight
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Sleep Disturbances
|
9.1%
1/11 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Elevated blood pressure
|
18.2%
2/11 • Number of events 2
|
0.00%
0/11
|
|
Renal and urinary disorders
Abdominal pain and pain on urinating
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Chest pain
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Orthostatic Hypotension
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Lightheadedness, dizziness
|
9.1%
1/11 • Number of events 1
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/11
|
9.1%
1/11 • Number of events 1
|
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