Trial Outcomes & Findings for Pharmacogenetic Trial of Doxazosin for Treatment of Cocaine Abuse (NCT NCT01953432)
NCT ID: NCT01953432
Last Updated: 2020-02-20
Results Overview
Over period of 12 weeks with 43 participants total (Doxazosin group = 22; Placebo group = 21), the overall percentage of cocaine positive urines per treatment group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to 12 weeks, or for the duration of the participant's involvement in the study
Results posted on
2020-02-20
Participant Flow
Participant milestones
| Measure |
Doxazosin
Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.
Doxazosin (target 8mg/day) Induction - Week 1: 1mg once daily over days 1--3; 2mg once daily over days 4-7; Week 2: 4mg once daily over days 8-10; 8mg once daily over days 11-14; Week 3: 8mg once daily over days 15-end of week 10
Doxazosin tapered over weeks 11-12 -- Week 11: 4mg on Monday, Tuesday, Wednesday, and Thursday and 1mg for the duration of week 11. During week 12, subjects will receive 1mg on Monday, Tuesday, and Wednesday only. No further medication will be given for the remainder of week 12.
|
Placebo
Matched placebo daily dosing.
Placebo: Matched placebo daily dosing
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
COMPLETED
|
8
|
6
|
|
Overall Study
NOT COMPLETED
|
14
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacogenetic Trial of Doxazosin for Treatment of Cocaine Abuse
Baseline characteristics by cohort
| Measure |
Doxazosin
n=22 Participants
Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.
Doxazosin (target 8mg/day) Induction - Week 1: 1mg once daily over days 1--3; 2mg once daily over days 4-7; Week 2: 4mg once daily over days 8-10; 8mg once daily over days 11-14; Week 3: 8mg once daily over days 15-end of week 10
Doxazosin tapered over weeks 11-12 -- Week 11: 4mg on Monday, Tuesday, Wednesday, and Thursday and 1mg for the duration of week 11. During week 12, subjects will receive 1mg on Monday, Tuesday, and Wednesday only. No further medication will be given for the remainder of week 12.
|
Placebo
n=21 Participants
Matched placebo daily dosing.
Placebo: Matched placebo daily dosing
|
Total
n=43 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
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.4 years
n=5 Participants
|
54.9 years
n=7 Participants
|
54.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Lifetime cocaine years
|
24.5 years
n=5 Participants
|
24.1 years
n=7 Participants
|
24.3 years
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeks, or for the duration of the participant's involvement in the studyPopulation: Study population was comprised of 43 cocaine-dependent individuals who met inclusion criteria for this study.
Over period of 12 weeks with 43 participants total (Doxazosin group = 22; Placebo group = 21), the overall percentage of cocaine positive urines per treatment group
Outcome measures
| Measure |
Doxazosin
n=22 Participants
Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.
Doxazosin (target 8mg/day) Induction - Week 1: 1mg once daily over days 1--3; 2mg once daily over days 4-7; Week 2: 4mg once daily over days 8-10; 8mg once daily over days 11-14; Week 3: 8mg once daily over days 15-end of week 10
Doxazosin tapered over weeks 11-12 -- Week 11: 4mg on Monday, Tuesday, Wednesday, and Thursday and 1mg for the duration of week 11. During week 12, subjects will receive 1mg on Monday, Tuesday, and Wednesday only. No further medication will be given for the remainder of week 12.
|
Placebo
n=21 Participants
Matched placebo daily dosing.
Placebo: Matched placebo daily dosing
|
|---|---|---|
|
Percentage of Cocaine-positive Urines
|
67.6 percentage of cocaine-positive urines
|
69 percentage of cocaine-positive urines
|
Adverse Events
Doxazosin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Doxazosin
n=22 participants at risk
Doxazosin is a long-acting and selective alpha 1-NE blocker, which inhibits the binding of norepinephrine to alpha receptors in the autonomic nervous system.
Doxazosin: Doxazosin is initiated at 2 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 4 weeks. Participants will be maintained on 8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15.
|
Placebo
n=21 participants at risk
Matched placebo daily dosing.
Placebo: Matched placebo daily dosing
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Number of events 2 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
General disorders
Dry mouth
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/22 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
9.5%
2/21 • Number of events 2 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
General disorders
Lightheadedness
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Infections and infestations
Cold/Viral Illness
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Gastrointestinal disorders
Stomach Pain/Indigestion
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
0.00%
0/21 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Immune system disorders
Swelling
|
0.00%
0/22 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
0.00%
0/22 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Immune system disorders
Allergies
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
0.00%
0/21 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
General disorders
Dizziness
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
0.00%
0/21 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/22 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
General disorders
Muscle twitching
|
0.00%
0/22 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Nervous system disorders
Numbness
|
4.5%
1/22 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
0.00%
0/21 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Psychiatric disorders
Increased Drug Craving
|
0.00%
0/22 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/22 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
4.8%
1/21 • Number of events 1 • Adverse events were assessed at each visit (Monday, Wednesday, Friday) during the active (medication) portion of the study for each participant (12 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place