Trial Outcomes & Findings for Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes? (NCT NCT01730846)
NCT ID: NCT01730846
Last Updated: 2018-02-20
Results Overview
Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
0 up to 50 minutes (Delay Period)
Results posted on
2018-02-20
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
Placebo controlled
|
4mg/Day
doxazosin 4mg/day
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
8mg/Day
doxazosin 8mg/day
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
13
|
|
Overall Study
COMPLETED
|
11
|
11
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
Baseline characteristics by cohort
| Measure |
Placebo
n=11 Participants
Placebo
Placebo controlled
|
4mg/Day
n=11 Participants
doxazosin 4mg/day
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
8mg/Day
n=13 Participants
doxazosin 8mg/day
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.36 years
STANDARD_DEVIATION 9.29 • n=5 Participants
|
34.82 years
STANDARD_DEVIATION 10.85 • n=7 Participants
|
34.23 years
STANDARD_DEVIATION 9.83 • n=5 Participants
|
35.40 years
STANDARD_DEVIATION 9.80 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 up to 50 minutes (Delay Period)Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo controlled
|
4mg/Day
n=11 Participants
doxazosin 4mg/day
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
8mg/Day
n=13 Participants
doxazosin 8mg/day
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
|---|---|---|---|
|
Latency (Min) to Initiate Ad-lib Smoking Session
Stress
|
11.304 minutes
Standard Error 7.407
|
32.128 minutes
Standard Error 7.494
|
27.557 minutes
Standard Error 6.409
|
|
Latency (Min) to Initiate Ad-lib Smoking Session
Neutral
|
23.474 minutes
Standard Error 8.312
|
26.790 minutes
Standard Error 8.410
|
23.776 minutes
Standard Error 7.192
|
SECONDARY outcome
Timeframe: 60 minutes (ad-lib smoking period)Number of cigarettes smoked during the stress and neutral ad-lib smoking period. Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.
Outcome measures
| Measure |
Placebo
n=11 Participants
Placebo
Placebo controlled
|
4mg/Day
n=11 Participants
doxazosin 4mg/day
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
8mg/Day
n=13 Participants
doxazosin 8mg/day
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
|---|---|---|---|
|
Number of Cigarettes Smoked During Ad-lib Session
Stress
|
3.331 number of cigarettes
Standard Error 0.563
|
1.890 number of cigarettes
Standard Error 0.561
|
1.813 number of cigarettes
Standard Error 0.493
|
|
Number of Cigarettes Smoked During Ad-lib Session
Neutral
|
2.139 number of cigarettes
Standard Error 0.397
|
1.866 number of cigarettes
Standard Error 0.396
|
1.688 number of cigarettes
Standard Error 0.348
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
4mg/Day
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
8mg/Day
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=11 participants at risk
Placebo
Placebo controlled
|
4mg/Day
n=11 participants at risk
doxazosin 4mg/day
Doxazosin: 4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
8mg/Day
n=13 participants at risk
doxazosin 8mg/day
Doxazosin: 8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
18.2%
2/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
30.8%
4/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Headache
|
27.3%
3/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
27.3%
3/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
38.5%
5/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Dizziness
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
27.3%
3/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
15.4%
2/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Drowsiness
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
45.5%
5/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
23.1%
3/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Back pain
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
9.1%
1/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
Cardiac disorders
Chest pain
|
9.1%
1/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Pain
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
7.7%
1/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
Cardiac disorders
Fast heartbeat
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
9.1%
1/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
23.1%
3/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Dry mouth
|
9.1%
1/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
27.3%
3/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
7.7%
1/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Abnormal vision
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
15.4%
2/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Impotence
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
9.1%
1/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Urinary tract infection
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Increased sweating
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Anxiety
|
0.00%
0/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
9.1%
1/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
0.00%
0/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
|
General disorders
Insomnia
|
9.1%
1/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
9.1%
1/11 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
7.7%
1/13 • Titration period (3 weeks)
Adverse events were assessed twice weekly with a symptom list during the 3-week titration period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place