Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
This study has been completed.
Sponsor:
University of New Mexico
Collaborator:
Information provided by (Responsible Party):
Michael Bogenschutz, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00721526
First received: July 22, 2008
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
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 |
|---|---|---|
|
Alcohol Dependence Anxiety Disorder |
Drug: disulfiram plus lorazepam |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Disulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder |
Resource links provided by NLM:
Further study details as provided by University of New Mexico:
Primary Outcome Measures:
- Percent days abstinent from alcohol [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- retention in treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- drinking consequences [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Percent days abstinent from alcohol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- drinks per drinking day [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
- remission status [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
- time to first heavy drinking day [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
- Hamilton anxiety scale score [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
- adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 45 |
| Study Start Date: | August 2009 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Disulfiram plus lorazepam
Disulfiram plus lorazepam
|
Drug: disulfiram plus lorazepam
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females age 18 and over with alcohol dependence.
- Able to provide voluntary informed consent.
- At least 4 heavy drinking days in the past 30 days.
- Primary or secondary anxiety disorder, including diagnoses of generalized anxiety disorder, panic disorder, social phobia, PTSD, obsessive-compulsive disorder, alcohol-induced anxiety disorder, or anxiety disorder not otherwise specified, ascertained by the SCID.
- Goal of abstinence.
- 2 days abstinence at the time of study entry (did not drink yesterday or today).
- Willing to come to clinic 3x/week.
- If female of child-bearing potential, willing to use approved method of contraception.
Exclusion Criteria:
- Moderate or severe withdrawal (CIWA-A greater than 15), history of withdrawal seizures or delirium tremens.
- Medical conditions (seizure disorder, sleep apnea, significantly impaired liver function, chronic or acute nephritis, symptomatic coronary artery disease, acute narrow-angle glaucoma).
- Urine drug screen positive for opioids or barbiturates.
- Hypersensitivity to thiuram derivatives.
- Pregnancy.
- Laboratory abnormalities (any LFT greater than 3 times normal, ECG evidence of ischemia, UA suggestive of nephritis, serious abnormalities of CBC).
- Need to take excluded medication (e.g. amprenavir oral solution, diazoxide oral suspension, isoniazid, lopinavir/ritonavir oral solution, metronidazole, omeprazole, phenytoins, ritonavir, tinidazole, tipranavir, warfarin, azelastine, sodium oxybate).
- Psychiatric conditions (schizophrenia, schizoaffective disorder, bipolar disorder; opioid dependence, benzodiazepine or other sedative hypnotic dependence).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721526
Locations
| United States, New Mexico | |
| University of New Mexico Addiction and Substance Abuse Programs | |
| Albuquerque, New Mexico, United States, 87106 | |
Sponsors and Collaborators
University of New Mexico
Investigators
| Principal Investigator: | Michael P. Bogenschutz, M. D. | University of New Mexico Health Sciences Center |
More Information
No publications provided
| Responsible Party: | Michael Bogenschutz, Professor of Psychiatry, University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT00721526 History of Changes |
| Other Study ID Numbers: | NIAAA-BOG_AA016555, K24AA016555, NIH Grant K24AA016555 |
| Study First Received: | July 22, 2008 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of New Mexico:
|
alcohol dependence alcoholism anxiety disorder |
pharmacotherapy disulfiram lorazepam |
Additional relevant MeSH terms:
|
Alcoholism Anxiety Disorders Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Disulfiram Lorazepam Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Alcohol Deterrents Central Nervous System Agents Therapeutic Uses Anticonvulsants |
Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013