Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
The proposed design is a single-group open-label trial. Qualified consenting participants
with active alcohol dependence and primary or secondary anxiety disorder will receive
monitored disulfiram and lorazepam, in the context of a structured Medication Management (MM)
model. In weeks 9-15 lorazepam is tapered, and disulfiram is stopped at the end of week 16.
Participants who achieve 4 weeks abstinence and meet criteria for a primary anxiety disorder
or mood disorder may receive ancillary medication consisting FDA-approved non-benzodiazepine
treatment, with specific options for each disorder described in the protocol. Participants
requiring continued treatment are referred to clinical treatment in the community at week 16,
and bridging prescriptions of anxiolytic/antidepressant medication may be provided. A final
follow-up assessment occurs at week 28. The primary outcomes are Percent Days Abstinent (PDA)
and retention in treatment. Secondary alcohol outcomes are consequences, drinks per drinking
day, remission status, and time to first heavy drinking day. Anxiety outcomes are Hamilton
Anxiety Scale scores and anxiety disorder diagnosis.
Phase:
Phase 4
Details
Lead Sponsor:
University of New Mexico
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)