Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

NCT00721526 | Completed Phase 4 Results DMC

• 2 other identifiers: NIAAA-BOG_AA016555K24AA016555
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Keywords

alcohol dependence; alcoholism; anxiety disorder; pharmacotherapy; disulfiram; lorazepam

Outcome Measures

Primary Outcomes (1)

• Treatment Adherence

  Completion of 16 weeks of disulfiram treatment

  16 weeks

Secondary Outcomes (4)

• Percent Days Abstinent From Alcohol (Intent-to-treat Sample)

  Weeks 13-16 (Last 4 weeks of treatment)

• Categorical Abstinence (Intent-to-treat Sample)

  Weeks 13-16 (Last 4 weeks of treatment)

• Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)

  Weeks 13-16 (Last 4 weeks of treatment)

• Categorical Abstinence (Among Those Observed at Week 16)

  Weeks 13-16 (Last 4 weeks of treatment)

Study Arms (1)

Disulfiram plus lorazepam

EXPERIMENTAL

Disulfiram plus lorazepam

Drug: disulfiram plus lorazepam

Interventions

disulfiram plus lorazepam DRUG

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

Disulfiram plus lorazepam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of New Mexico: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of New Mexico Addiction and Substance Abuse Programs

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders

Interventions

Disulfiram; Lorazepam

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michael Bogenschutz
• Organization: NYU Grossman School of Medicine

Michael.Bogenschutz@nyulangone.org

505-999-9325

Study Officials

• Michael P. Bogenschutz, M. D.

  University of New Mexico Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: August 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 30, 2023
• Results First Posted: August 30, 2023

Record last verified: 2023-08

Locations

US (1)