Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders
Status:
Completed
Trial end date:
2018-10-10
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Collaborators:
United States Department of Defense VA Puget Sound Health Care System