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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
University of New Mexico Addiction and Substance Abuse Programs
Albuquerque, New Mexico, United States
Treatment Adherence
Completion of 16 weeks of disulfiram treatment
Time frame: 16 weeks
Percent Days Abstinent From Alcohol (Intent-to-treat Sample)
As measured by Timeline Followback
Time frame: Weeks 13-16 (Last 4 weeks of treatment)
Categorical Abstinence (Intent-to-treat Sample)
As measured by timeline followback
Time frame: Weeks 13-16 (Last 4 weeks of treatment)
Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)
As measured by Timeline Followback
Time frame: Weeks 13-16 (Last 4 weeks of treatment)
Categorical Abstinence (Among Those Observed at Week 16)
As measured by timeline followback
Time frame: Weeks 13-16 (Last 4 weeks of treatment)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.