Trial Outcomes & Findings for Testing Doxazosin to Treat Stress Mechanisms in Alcoholism (NCT NCT02989493)

Last Updated: 2021-03-18

Results Overview

Startle potentiation is used to study anxiety and fear with No-shock, Predictable-shock, Unpredictable-shock (NPU) task; a common, well-validated laboratory stressor task. In the Predictable condition of the NPU task, shocks are 100 percent predictable and occur at a consistent, known time. In the Unpredictable condition of the NPU task, shocks are fully unpredictable. A higher score on startle potentiation means a higher stress reactivity response for the given condition.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

61 participants

Primary outcome timeframe

4 weeks

Results posted on

2021-03-18

Participant Flow

Participants were enrolled via community advertisement and clinical referral.

61 participants were consented, passed medical screening, and were assigned to a drug group.

Participant milestones

Participant milestones
Measure	Doxazosin Participants receive 8 weeks of doxazosin (8mg target dose). Doxazosin: Doxazosin	Placebo Participants will receive 8 weeks of matched placebo. Placebo: Placebo
Overall Study STARTED	29	32
Overall Study COMPLETED	29	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing Doxazosin to Treat Stress Mechanisms in Alcoholism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxazosin n=29 Participants Participants receive 8 weeks of doxazosin (8mg target dose). Doxazosin: Doxazosin	Placebo n=32 Participants Participants will receive 8 weeks of matched placebo. Placebo: Placebo	Total n=61 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 11.9 • n=5 Participants	39.7 years STANDARD_DEVIATION 10.8 • n=7 Participants	42.5 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	30 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	29 participants n=5 Participants	32 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Although all 61 participants were able to provide TLFB data through the end of 8 weeks, the NPU task required that they attend a study visit at 4 weeks. 24 participants (10 in doxazosin, 13 in placebo) did not complete that study visit and so have data missing for this outcome measure. 1 (doxazosin) attended the visit but chose not to complete the NPU task. 2 participants (both placebo) completed NPU at this visit, but their NPU data was unusable for this analysis due to technical issues.

Outcome measures

Outcome measures
Measure	Doxazosin n=18 Participants Participants receive 8 weeks of doxazosin (8mg target dose). Doxazosin: Doxazosin	Placebo n=17 Participants Participants will receive 8 weeks of matched placebo. Placebo: Placebo
Startle Potentiation During Stress Reactivity Task Unpredictable startle potentiation	22.25 microvolts Standard Deviation 20.18	20.76 microvolts Standard Deviation 23.21
Startle Potentiation During Stress Reactivity Task Predictable startle potentiation	26.22 microvolts Standard Deviation 30.90	22.21 microvolts Standard Deviation 35.93

PRIMARY outcome

Timeframe: 8 weeks

Timeline-followback (TLFB) was administered twice at 4 weeks and 8 weeks. Participants reported the number of drinks per day for each previous 30 day period. Any heavy drinking was scored "yes" if participant reported any days of heavy drinking (\> 4/3 standard drinks for men/women) during the total 8 week assessment period; "no" if no heavy drinking was reported

Outcome measures

Outcome measures
Measure	Doxazosin n=29 Participants Participants receive 8 weeks of doxazosin (8mg target dose). Doxazosin: Doxazosin	Placebo n=32 Participants Participants will receive 8 weeks of matched placebo. Placebo: Placebo
Number of Participants Reporting Any Heavy Drinking Days	17 Participants	21 Participants

Adverse Events

Doxazosin

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Doxazosin n=29 participants at risk Participants receive 8 weeks of doxazosin (8mg target dose). Doxazosin: Doxazosin	Placebo n=32 participants at risk Participants will receive 8 weeks of matched placebo. Placebo: Placebo
Vascular disorders Orthostatic hypertension	48.3% 14/29 • Number of events 24 • 8 weeks	21.9% 7/32 • Number of events 18 • 8 weeks
Ear and labyrinth disorders Dizziness	31.0% 9/29 • Number of events 17 • 8 weeks	21.9% 7/32 • Number of events 9 • 8 weeks
Cardiac disorders Cardiac arrhythmia	27.6% 8/29 • Number of events 12 • 8 weeks	18.8% 6/32 • Number of events 7 • 8 weeks
Cardiac disorders Chest pains	6.9% 2/29 • Number of events 5 • 8 weeks	0.00% 0/32 • 8 weeks
General disorders Fatigue	51.7% 15/29 • Number of events 38 • 8 weeks	53.1% 17/32 • Number of events 36 • 8 weeks
Cardiac disorders Edema	10.3% 3/29 • Number of events 6 • 8 weeks	0.00% 0/32 • 8 weeks
General disorders Rhinitis	44.8% 13/29 • Number of events 29 • 8 weeks	15.6% 5/32 • Number of events 9 • 8 weeks
General disorders Headache	31.0% 9/29 • Number of events 25 • 8 weeks	34.4% 11/32 • Number of events 17 • 8 weeks
Respiratory, thoracic and mediastinal disorders Dyspnea	13.8% 4/29 • Number of events 4 • 8 weeks	9.4% 3/32 • Number of events 5 • 8 weeks
General disorders Dry mouth	34.5% 10/29 • Number of events 30 • 8 weeks	25.0% 8/32 • Number of events 15 • 8 weeks
Gastrointestinal disorders Nausea or diarrhea	31.0% 9/29 • Number of events 14 • 8 weeks	25.0% 8/32 • Number of events 9 • 8 weeks
Eye disorders Blurry vision	13.8% 4/29 • Number of events 4 • 8 weeks	0.00% 0/32 • 8 weeks
Renal and urinary disorders Polyurea	6.9% 2/29 • Number of events 6 • 8 weeks	12.5% 4/32 • Number of events 8 • 8 weeks
General disorders General symptoms, nonspecific	27.6% 8/29 • Number of events 9 • 8 weeks	18.8% 6/32 • Number of events 10 • 8 weeks
Reproductive system and breast disorders Priapism	10.5% 2/19 • Number of events 2 • 8 weeks	0.00% 0/20 • 8 weeks

Additional Information

John Curtin

University of Wisconsin

Phone: 608-262-0387

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place