NCT00721526

Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

Disulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcohol Dependence
• Anxiety Disorder

Interventions

Type	Name	Description
DRUG	disulfiram plus lorazepam	Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-07-24
• Last updated: 2023-08-30
• Results posted: 2023-08-30

Locations

1 site across 1 country: United States