Trial Outcomes & Findings for Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD (NCT NCT02226367)

Last Updated: 2023-02-03

Results Overview

Penn Alcohol Craving Scale (PACS) The PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

Change at Week 13 from Baseline

Results posted on

2023-02-03

Participant Flow

Active duty soldiers participating in command mandated Army outpatient alcohol treatment were randomized to the brain-penetrant alpha-1 adrenergic receptor antagonist prazosin or placebo for 13 weeks. The period of enrollment and completion of study procedures was January, 2015, through July, 2018. The study was ended following enrollment of 158 participants due to end of funding.

Participant milestones

Participant milestones
Measure	Prazosin Hydrochloride Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin	Placebo Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo
Overall Study STARTED	46	56
Overall Study COMPLETED	37	49
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prazosin Hydrochloride n=46 Participants Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin	Placebo n=56 Participants Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo	Total n=102 Participants Total of all reporting groups
Age, Continuous	29.2 years STANDARD_DEVIATION 6.5 • n=5 Participants	29.8 years STANDARD_DEVIATION 6.8 • n=7 Participants	29.6 years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	53 Participants n=7 Participants	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	47 Participants n=7 Participants	85 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	1 Participants n=7 Participants	1 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	4 Participants n=5 Participants	9 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	56 participants n=7 Participants	102 participants n=5 Participants

PRIMARY outcome

Timeframe: Change at Week 13 from Baseline

Outcome measures

Outcome measures
Measure	Prazosin Hydrochloride n=46 Participants Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin	Placebo n=56 Participants Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo
Change in Penn Alcohol Craving Scale Score	7.4 units on a scale Standard Error 4.1	8.8 units on a scale Standard Error 6.4

Adverse Events

Prazosin Hydrochloride

Serious events: 2 serious events

Other events: 44 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prazosin Hydrochloride n=46 participants at risk Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin	Placebo n=56 participants at risk Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo
General disorders skull fracture and subdural hematoma	0.00% 0/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	1.8% 1/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
Psychiatric disorders Suicidal Ideation	2.2% 1/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	0.00% 0/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
Psychiatric disorders anxiety associated with occupational stressors	2.2% 1/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	0.00% 0/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.

Other adverse events

Other adverse events
Measure	Prazosin Hydrochloride n=46 participants at risk Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects. prazosin hydrochloride: study drug arm prazosin	Placebo n=56 participants at risk Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment. placebo: study drug arm placebo
General disorders dizziness on standing	39.1% 18/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	16.1% 9/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
General disorders Nasal Congestion	52.2% 24/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	32.1% 18/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
Gastrointestinal disorders Nausea	30.4% 14/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	14.3% 8/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
General disorders Lightheadedness	47.8% 22/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	28.6% 16/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
General disorders Weakness	21.7% 10/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	10.7% 6/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
Cardiac disorders Palpitations	17.4% 8/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	8.9% 5/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
General disorders Peripheral edema	2.2% 1/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	7.1% 4/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.
Psychiatric disorders Depressed Mood	6.5% 3/46 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.	25.0% 14/56 • Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks. This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.

Additional Information

Murray Raskind, MD

VA Puget Sound Health Care System

Phone: (206) 277-3797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place