Alcohol Use Disorders, Stress Disorders, Posttraumatic, Combat Disorders
Conditions
Keywords
prazosin, alcohol use disorders, posttraumatic stress disorder, PTSD, combat trauma, military, alpha-1 adrenoreceptor antagonist
Brief summary
The purpose of the study is to evaluate if the drug prazosin: * will decrease alcohol use in active duty members of the military who served in Iraq and/or Afghanistan and * determine if presence or absence of posttraumatic stress disorder affects treatment.
Detailed description
The proposed study is a 19-week, titration to stable dose, randomized, two-group parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin for decreasing alcohol use in 200 active duty Service Members who served in the conflicts in Iraq and/or Afghanistan who are receiving standard outpatient treatment for alcohol use disorders at Joint Base Lewis-McChord. Treatment groups will be stratified by presence or absence of posttraumatic stress disorder (PTSD) and by assignment to the 6-week or 12-week Army Substance Abuse Program. The hypotheses are that: 1) prazosin is more effective than placebo for alcohol use disorders in these Service Members; and 2) that prazosin effect size will be greater in Service Members with PTSD than without PTSD.
Interventions
study drug arm prazosin
DRUGplacebo
study drug arm placebo
Sponsors
United States Department of Defense
VA Puget Sound Health Care System
Seattle Institute for Biomedical and Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female active duty returnees from the conflicts in Iraq and/or Afghanistan over the age of 21 with a current Diagnostic and Statistical Manual of Mental Disorders IV diagnosis of Alcohol Abuse or Dependence or a current Diagnostic and Statistical Manual of Mental Disorders 5 diagnosis of Alcohol Use Disorder * Participant in Army Substance Abuse Program (6 or 12 week program) * Recent alcohol consumption: more than 14 (women) or 21 (men) drinks per week for at least 2 weeks in the past 60 day period OR at least 2 days of heavy drinking in the past 60 day period (4 or more drinks for women and 5 or more drinks for men) * Good general medical health (see
Exclusion criteria
below) * Women of childbearing potential must agree to abstain from sexual relations that could result in pregnancy or use an effective method of birth control acceptable to both participant and the study clinician during the study. Men are not required to use contraception during the study. * Concomitant use of naltrexone and/or antabuse must be stable for 2 weeks prior to Baseline * Capacity to provide informed consent * English fluency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Penn Alcohol Craving Scale Score | Change at Week 13 from Baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 46 |
| Placebo Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.
placebo: study drug arm placebo | 56 |
| Total | 102 |
Baseline characteristics
| Characteristic | Prazosin Hydrochloride | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 6.5 | 29.6 years STANDARD_DEVIATION 6.6 | 29.8 years STANDARD_DEVIATION 6.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants | 85 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 13 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 10 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 13 Participants | 6 Participants |
| Race (NIH/OMB) White | 31 Participants | 64 Participants | 33 Participants |
| Region of Enrollment United States | 46 participants | 102 participants | 56 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 44 Participants | 97 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 56 |
| other Total, other adverse events | 44 / 46 | 52 / 56 |
| serious Total, serious adverse events | 2 / 46 | 1 / 56 |
Outcome results
Primary
Change in Penn Alcohol Craving Scale Score
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.
Time frame: Change at Week 13 from Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prazosin Hydrochloride | Change in Penn Alcohol Craving Scale Score | 7.4 units on a scale | Standard Error 4.1 |
| Placebo | Change in Penn Alcohol Craving Scale Score | 8.8 units on a scale | Standard Error 6.4 |