Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

NCT ID: NCT00721526

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2012-08-31

Brief 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.

Conditions

Alcohol Dependence; Anxiety Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Disulfiram plus lorazepam

Disulfiram plus lorazepam

Group Type: EXPERIMENTAL

disulfiram plus lorazepam

Intervention Type: DRUG

Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily

Interventions

disulfiram plus lorazepam

Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Michael Bogenschutz

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael P. Bogenschutz, M. D.

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico Health Sciences Center

Locations

University of New Mexico Addiction and Substance Abuse Programs

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

K24AA016555

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIAAA-BOG_AA016555

Identifier Type: -

Identifier Source: org_study_id