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Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

Information source: University of New Mexico
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Dependence; Anxiety Disorder

Intervention: disulfiram plus lorazepam (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of New Mexico

Official(s) and/or principal investigator(s):
Michael P. Bogenschutz, M. D., Principal Investigator, Affiliation: University of New Mexico Health Sciences Center

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Percent days abstinent from alcohol

retention in treatment

Secondary outcome:

drinking consequences

Percent days abstinent from alcohol

drinks per drinking day

remission status

time to first heavy drinking day

Hamilton anxiety scale score

adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

University of New Mexico Addiction and Substance Abuse Programs, Albuquerque, New Mexico 87106, United States
Additional Information

Starting date: August 2009
Last updated: January 28, 2013

Page last updated: August 23, 2015

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