Trial Outcomes & Findings for Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin (NCT NCT01916941)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

from 2-4 weeks and from 4-6 weeks

Results posted on

2017-10-17

Participant milestones
Measure	Prazosin Prazosin titrated to 16 mg daily x 6 weeks Prazosin	Placebo Placebo X 6 weeks Placebo
Overall Study STARTED	18	18
Overall Study COMPLETED	13	14
Overall Study NOT COMPLETED	5	4

Withdrawal data not reported

Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin

Baseline characteristics by cohort
Measure	Prazosin n=18 Participants Prazosin titrated to 16 mg daily x 6 weeks Prazosin	Placebo n=18 Participants Placebo X 6 weeks Placebo	Total n=36 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	18 Participants n=5 Participants	18 Participants n=7 Participants	36 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	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants	18 Participants n=7 Participants	36 Participants n=5 Participants

Timeframe: from 2-4 weeks and from 4-6 weeks

Outcome measures
Measure	Prazosin n=18 Participants Prazosin titrated to 16 mg daily x 6 weeks Prazosin	Placebo n=18 Participants Placebo X 6 weeks Placebo
Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week) from 4-6 weeks	15.11 drinks per week Standard Deviation 23.66	11.11 drinks per week Standard Deviation 15.01
Number of Standard Alcoholic Drinks Consumed Per Week (Drinks Per Week) from 2-4 weeks	13.65 drinks per week Standard Deviation 18.92	14.55 drinks per week Standard Deviation 17.29

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Prazosin n=18 participants at risk Prazosin titrated to 16 mg daily x 6 weeks Prazosin	Placebo n=18 participants at risk Placebo X 6 weeks Placebo
Cardiac disorders Dizziness on standing	55.6% 10/18	22.2% 4/18

University of New Mexico

Phone: 505-272-2333