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NCT00721526 · ClinicalTrials.gov registry record · Phase 4
Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
A Phase 4 study, sponsored by University of New Mexico.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
NCT00721526: Completed Phase 4 study, sponsored by University of New Mexico.
NCT00721526 is a Phase 4 study that has completed, run by University of New Mexico. The registered enrollment target is 41 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00721526, a Phase 4 study, has completed, sponsored by University of New Mexico.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
Study 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.
Primary Outcome
Completion of 16 weeks of disulfiram treatment
Interventions
- DRUG disulfiram plus lorazepam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
What the finished NCT00721526 record still lists
NCT00721526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which disulfiram plus lorazepam is the first listed.
NCT00721526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00721526 about?
NCT00721526 is a clinical study titled "Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder". 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...
What is the current status of trial NCT00721526?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2009-08. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00721526?
The interventions under investigation include: disulfiram plus lorazepam (DRUG).
Who is sponsoring clinical trial NCT00721526?
This trial is sponsored by University of New Mexico, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00721526's enrollment target sits among peer trials
41 1390th of 2000 higher than 604 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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