Phase 2
N=30
Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder
Alcohol Abuse · Posttraumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01518972 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Percent Drinking Days Per Week — 18.1; 49.3 percentage of drinking days per week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prazosin (Drug); Placebo medication (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Drinking Days Per Week |
18.1; 49.3 | — |
| PRIMARY Percent Heavy Drinking Days Per Week |
3.7; 27.4 | — |
| PRIMARY Total Drinks Per Week |
7.9; 27 | — |
| SECONDARY PTSD Symptom Assessments |
3.1; 2.5; 3.2; 2.6; 2.9; 2.4 | — |
Summary
The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).
Eligibility Criteria
Inclusion Criteria
- Current primary DSM-IV diagnosis of alcohol dependence(AD)
- Current DSM-IV diagnosis of PTSD
- At least 14 (women) or 21 (men) drinks per week AND at least 2 days of heavy drinking during a consecutive 30 day period in the last 90 days
- Desire to abstain from drinking
- At least 18 years of age
- Good general medical health (see Exclusion Criteria below)
- Capacity to provide informed consent
- English fluency
Exclusion Criteria
Psychiatric/behavioral:
- psychiatric disorder requiring any medication other than anti-depressants (individuals not on a stable dose of an anti-depressant for at least 30 days prior to randomization will be excluded from the study)
- currently taking disulfiram, acamprosate, or naltrexone in the last 30 days or planning to take any of these medications during the 12-week medication phase of the study
- acutely suicidal or homicidal
- current dependence on any other psychoactive substance other than nicotine or cannabis
- a current diagnosis of opioid abuse, use of any opioid- containing medications, methamphetamines, or benzodiazepines during the previous month, or UDA positive for opioids, methamphetamines, benzodiazepines, or sedative hypnotics
Medical:
- significant acute or chronic medical illness including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic 20mmHg after two minutes standing or any drop with dizziness); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, Meniere's disease, benign positional vertigo, narcolepsy
- for males only, concomitant use of trazodone (or use in the last 7 days), tadalafil, or vardenafil (or use in the last 3 days) due to increased risk of priapism
- history of prazosin-sensitivity; no prazosin for at least the past 30 days
- women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the study physician or PA to be effective
- signs or symptoms of alcohol withdrawal at the time of initial consent
- legal involvement that could interfere with study treatment
- individuals court ordered for treatment will not be eligible to participate in this study
Data sourced from ClinicalTrials.gov (NCT01518972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.