Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder
Condition: Alcohol Abuse; Posttraumatic Stress Disorder
MeSH terms: Alcoholism; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Prazosin; Placebo medication
Intervention description: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg; Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
Intervention MeSH terms: Prazosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol; Abuse; Use; Disorder; Dependence; Symptoms; Alcoholic; Alcoholism; Prazosin; Drug; Medicine; Medication; Treatment; Study; Placebo; Medical; Management; Craving; Consumption; Binge; Drinking; Drink; Heavy; PTSD; Trauma; Post; Posttraumatic

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 <110) or orthostatic hypotension (defined as a systolic drop > 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