Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders

• Status: Completed
• Trial end date: 2018-10-10
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether the combination of prazosin and naltrexone will decrease alcohol cravings and drinking in individuals who have problems with alcohol and have used alcohol at risky levels compare to naltrexone and placebo (Nal/Pl), prazosin and placebo (Praz/Pl), and double-placebo (Pl/Pl). We hypothesize that those assigned to both prazosin and naltrexone would report significantly greater decreases in percent drinking days and heavy drinking days as well as significantly greater reduction in craving from pre to post-treatment than those assigned to either single medication or double-placebo.

Prazosin is a medication that is approved by the U.S. Food and Drug Administration (FDA) to treat people with high blood pressure. Some studies have shown that prazosin may also decrease nightmares and improve sleep in Veterans suffering from Posttraumatic Stress Disorder (PTSD). Animal studies have consistently found that prazosin is associated with decreased alcohol consumption and that the combination of prazosin and naltrexone outperforms either medication alone. The current study is evaluating an "off-label" use of prazosin to determine whether it is helpful in decreasing alcohol cravings and consumption among people with alcohol problems. "Off-label" means that the FDA has not approved the use of prazosin for alcohol problems.

Naltrexone is a medication that is FDA approved for treating alcohol problems.

This study is sponsored by the Department of Defense and the Congressionally Directed Medical Research Program (DoD/CDMRP). We expect approximately 120 participants in this study, which will run over approximately 4 years. Study participants will be involved in the study for 7 weeks, or until they complete the Final Assessment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: United States Department of Defense; VA Puget Sound Health Care System
• Treatments: Naltrexone; Prazosin

Criteria

Inclusion Criteria:

1. Veteran of the U.S. military or National Guard Reserve.

2. Current AUD by DSM-5 criteria.

3. 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).

4. At least mild alcohol craving as assessed by the Pennsylvania Alcohol Craving Scale (PACS; score > 10) at baseline.

5. Age 18-80.

6. English fluency and literacy.

7. Trying or planning to try to cut down on or abstain from alcohol.

8. Good general medical health.

9. Capable of giving informed consent.

Exclusion Criteria:

1. Uncontrolled psychiatric disorder with psychotic symptoms or cognitive impairment.

2. If taking psychiatric medication, NOT on a stable dose for at least 30 days prior to randomization.

3. Any suicidal ideation in the past 7 days, plan or intent past 6 months, or any suicide attempt past year.

4. Homicidal ideation with plan and intent in the past 30 days.

5. Patient Health Questionnaire-9 (PHQ-9) endorsement of hopelessness or self-harm/SI and/or sum scale score ≥ 19.

6. Any use of prazosin or naltrexone past 30 days.

7. Currently taking disulfiram or acamprosate OR planning to take any of these medications (including prazosin or naltrexone) during the study.

8. 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.

9. Significant acute or chronic medical illness

10. Preexisting hypotension (sys <100) or orthostatic hypotension (systolic drop of > 20 mmHg; after two minutes of standing, or any drop with dizziness).

11. Allergy or previous adverse reaction to naltrexone, prazosin, quinazolines, or other α-1 adrenergic blockers or use of other α -1 adrenergic blocker.

12. Women who are pregnant, breastfeeding, or of childbearing potential and not using a contraceptive method judged by the investigator to be effective.

13. Legal involvement that could interfere with study participation, including being court ordered for treatment.

14. Signs or symptoms of withdrawal at time of initial consent.

15. Any participation in an experimental drug study or any addiction study past 30 days.