Double-Blind Randomized Clinical Trial of Prazosin for Alcohol Use Disorder
Abstract
Objective:
Method:
Results:
Conclusions:
Method
Participants
Procedures
Study design.
Recruitment and screening.
Randomization.
Study visits.
Measures
Mental health diagnoses and symptoms.
Substance use.
Interactive voice response daily monitoring.
Study Treatments
Medications.
Medical management.
Statistical Analysis
Daily interactive voice response data.
Sensitivity analyses.
Exploratory analyses.
Results
Characteristic | Placebo Group (N=44) | Prazosin Group (N=48) | ||
---|---|---|---|---|
Mean | SD | Mean | SD | |
Age (years) | 49.1 | 9.5 | 47.3 | 9.8 |
N | % | N | % | |
Male | 36 | 81.8 | 37 | 77.1 |
Ethnicity | ||||
Non-Hispanic white | 23 | 53.5 | 29 | 59.6 |
Black | 13 | 30.2 | 15 | 31.9 |
Hispanic | 5 | 11.6 | 2 | 4.3 |
Other | 3 | 4.7 | 2 | 4.3 |
Veteran | 9 | 20.5 | 9 | 18.8 |
Marital status | ||||
Never married | 20 | 46.2 | 33 | 68.2 |
Married | 8 | 19.2 | 4 | 9.1 |
Separated or divorced | 14 | 30.8 | 9 | 18.2 |
Widowed or other | 2 | 3.8 | 2 | 4.5 |
Employed (part-time or full-time) | 39.5 | 44.4 | ||
Mean | SD | Mean | SD | |
Baseline drinking information for the preceding 90-day perioda | ||||
Total standard drink units | 815 | 547 | 824 | 439 |
Percent days drinking | 76.6 | 22.4 | 76.8 | 27.5 |
Percent heavy drinking days | 66.5 | 26.0 | 71.8 | 29.1 |
Average drinks per day | 9.1 | 6.1 | 9.2 | 4.9 |
Average drinks per drinking day | 12.1 | 7.2 | 12.8 | 6.8 |
Drinking across the last week of medication useb | ||||
Percent days drinking | 35.5 | 39.7 | 43.0 | 44.0 |
Percent days heavy drinking | 22.6 | 34.1 | 11.4 | 22.8 |
Average drinks per day | 2.4 | 3.8 | 2.0 | 3.0 |
Average drinks per drinking dayc | 6.3 | 5.7 | 4.6 | 4.0 |
Primary Outcomes: Effect of Prazosin and Time on Daily Drinking Outcomes
Prazosin Group (N=40) | Placebo Group (N=40) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Week 3 | Week 12 | Changeb | Week 3 | Week 12 | Changeb | Difference in Changeb | ||||||
Drinking Outcome | Mean | Mean | Mean | 95% CI | Mean | Mean | Mean | 95% CI | Mean | 95% CI | χ2 | p |
Number of drinks per week | 21.3 | 13.3 | 8.0 | 1.8, 19.5 | 14.6 | 13.1 | 1.5 | –3.4, 6.8 | 6.5 | –2.4, 19.1 | 4.50 | 0.03 |
Number of drinking days per week | 3.2 | 2.8 | 0.4 | 0.1, 0.8 | 2.8 | 2.3 | 0.5 | 0.1, 0.7 | 0.0 | –0.4, 0.5 | 0.006 | 0.94 |
Number of heavy drinking days per week | 1.8 | 1.0 | 0.8 | 0.3, 1.0 | 1.5 | 1.2 | 0.3 | 0.0, 0.5 | 0.5 | 0.0, 0.8 | 6.55 | 0.01 |
Secondary Outcome, Sensitivity Analyses, and Exploratory Analyses
Adherence
Prazosin Group (N=40) | Placebo Group (N=40) | |||
---|---|---|---|---|
Measure | Mean | SD | Mean | SD |
Percent daily adherence to daily interactive voice response questions | 68.8 | 29.7 | 76.6 | 31.4 |
Number of days in study | 71.6 | 20.6 | 73.6 | 21.7 |
Percent days reported taking any study medicationa | 64.8 | 31.0 | 75.6 | 31.8 |
Visits with positive riboflavin tracea | 64.1 | 26.0 | 71.3 | 28.6 |
Safety Findings
Adverse events.
Side effects.
Prazosin Group (N=44) | Placebo Group (N=48) | ||||
---|---|---|---|---|---|
Event or Side Effect | Mean | SD | Mean | SD | p |
Drowsiness | 28 | 58.3 | 15 | 34.1 | 0.020 |
Edema | 9 | 18.8 | 2 | 4.6 | 0.036 |
Dizziness | 20 | 41.7 | 14 | 31.8 | 0.328 |
Light-headedness | 23 | 47.9 | 17 | 38.6 | 0.370 |
Headache | 17 | 35.4 | 17 | 38.6 | 0.749 |
Lacking energy | 23 | 47.9 | 16 | 36.4 | 0.263 |
Weakness | 10 | 20.8 | 6 | 13.6 | 0.363 |
Palpitations | 11 | 22.9 | 5 | 11.4 | 0.144 |
Nausea | 18 | 37.5 | 11 | 25.0 | 0.197 |
Change in urination | 9 | 18.8 | 5 | 11.4 | 0.324 |
Discussion
Acknowledgments
Footnote
Supplementary Material
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