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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00721526 |
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.
Condition | Intervention | Phase |
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Alcohol Dependence Anxiety Disorder |
Drug: disulfiram plus lorazepam |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Disulfiram Combined With Lorazapam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder |
Estimated Enrollment: | 40 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | April 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael P. Bogenschutz, M. D. | 505-272-8428 | mbogenschutz@salud.unm.edu |
United States, New Mexico | |
University of New Mexico Addiction and Substance Abuse Programs | |
Albuquerque, New Mexico, United States, 87106 |
Principal Investigator: | Michael P. Bogenschutz, M. D. | University of New Mexico Health Sciences Center |
Responsible Party: | University of new Mexico Health Sciences Center ( Michael P. Bogenschutz, M.D. Professor of Psychiatry ) |
Study ID Numbers: | AA016555 |
Study First Received: | July 22, 2008 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00721526 |
Health Authority: | United States: Federal Government |
alcohol dependence alcoholism anxiety disorder |
pharmacotherapy disulfiram lorazepam |
Disulfiram Lorazepam Anxiety Disorders Mental Disorders Alcoholism |
Substance-Related Disorders Neoplasm Metastasis Disorders of Environmental Origin Alcohol-Related Disorders Ethanol |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Enzyme Inhibitors |
Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Alcohol Deterrents |