Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by University of New Mexico. The registered enrollment target is 41 participants.
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.
Interventions
- DRUG disulfiram plus lorazepam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00721526
The ClinicalTrials.gov registry entry for NCT00721526 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of New Mexico, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which disulfiram plus lorazepam is the first listed.
NCT00721526 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.