Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders (PaN)
Alcohol Use Disorder, Posttraumatic Stress Disorder (PTSD)
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcohol Drinking, Craving, Drinking Behavior, Prazosin, Naltrexone, Adrenergic Alpha-1 Receptor Antagonists, Adrenergic Antagonists, Adrenergic Alpha-Antagonists, mu-Opioid Receptor Antagonist, Opioid Antagonist, Alcohol Use Disorder, Posttraumatic Stress Disorder, PTSD, Alcohol Treatment, Alcohol Dependence, Pharmacology Treatment, AUD, Alcohol Abuse, Substance Use Disorder, SUD, Substance Abuse, Addiction, Alcohol Addiction, Substance Addiction, Substance Dependence
Eligibility Criteria
Inclusion Criteria:
- Veteran of the U.S. military or National Guard Reserve.
- Current AUD by DSM-5 criteria.
- Heavy drinking (>14 drinks per week for females; > 21 drinks per week for males) for at least 2 weeks in the last 3 months and some drinking during the past two weeks OR binge drinking for at least 3 days in the last month (4+ drinks for females; 5+ drinks for males).
- At least mild alcohol craving as assessed by the Pennsylvania Alcohol Craving Scale (PACS; score > 10) at baseline.
- Age 18-80.
- English fluency and literacy.
- Trying or planning to try to cut down on or abstain from alcohol.
- Good general medical health.
- Capable of giving informed consent.
Exclusion Criteria:
- Uncontrolled psychiatric disorder with psychotic symptoms or cognitive impairment.
- If taking psychiatric medication, NOT on a stable dose for at least 30 days prior to randomization.
- Any suicidal ideation in the past 7 days, plan or intent past 6 months, or any suicide attempt past year.
- Homicidal ideation with plan and intent in the past 30 days.
- Patient Health Questionnaire-9 (PHQ-9) endorsement of hopelessness or self-harm/SI and/or sum scale score ≥ 19.
- Any use of prazosin or naltrexone past 30 days.
- Currently taking disulfiram or acamprosate OR planning to take any of these medications (including prazosin or naltrexone) during the study.
- Current moderate or severe substance use disorder (past 30 days) on any psychoactive substance other than alcohol, nicotine, or cannabis, OR use of any amphetamine or opioid-containing medications during the previous 30 days.
- Significant acute or chronic medical illness
- Preexisting hypotension (sys <100) or orthostatic hypotension (systolic drop of > 20 mmHg; after two minutes of standing, or any drop with dizziness).
- Allergy or previous adverse reaction to naltrexone, prazosin, quinazolines, or other α-1 adrenergic blockers or use of other α -1 adrenergic blocker.
- Women who are pregnant, breastfeeding, or of childbearing potential and not using a contraceptive method judged by the investigator to be effective.
- Legal involvement that could interfere with study participation, including being court ordered for treatment.
- Signs or symptoms of withdrawal at time of initial consent.
- Any participation in an experimental drug study or any addiction study past 30 days.
Sites / Locations
- VA Puget Sound Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Praz/Nal
Praz/Pl
Nal/Pl
Pl/Pl
Prazosin and Naltrexone. Prazosin will be taken following this titration schedule: Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Prazosin and Placebo (Naltrexone) Prazosin will be taken following this titration schedule: Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Naltrexone and Placebo (Prazosin) Prazosin Placebo will be taken following this titration schedule: Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Naltrexone will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.
Placebo (Prazosin) and Placebo (Naltrexone) Prazosin Placebo will be taken following this titration schedule: Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Naltrexone Placebo will be taken from day 1 to day 42 at 9 PM. Dose: 50 mg.