Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

August 10, 2023 updated by: Michael Bogenschutz, University of New Mexico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disulfiram plus lorazepam
Drug: disulfiram plus lorazepam
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Adherence
Time Frame: 16 weeks
Completion of 16 weeks of disulfiram treatment
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Days Abstinent From Alcohol (Intent-to-treat Sample)
Time Frame: Weeks 13-16 (Last 4 weeks of treatment)
As measured by Timeline Followback
Weeks 13-16 (Last 4 weeks of treatment)
Categorical Abstinence (Intent-to-treat Sample)
Time Frame: Weeks 13-16 (Last 4 weeks of treatment)
As measured by timeline followback
Weeks 13-16 (Last 4 weeks of treatment)
Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)
Time Frame: Weeks 13-16 (Last 4 weeks of treatment)
As measured by Timeline Followback
Weeks 13-16 (Last 4 weeks of treatment)
Categorical Abstinence (Among Those Observed at Week 16)
Time Frame: Weeks 13-16 (Last 4 weeks of treatment)
As measured by timeline followback
Weeks 13-16 (Last 4 weeks of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Michael P. Bogenschutz, M. D., University of New Mexico Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

July 22, 2008

First Submitted That Met QC Criteria

July 22, 2008

First Posted (Estimated)

July 24, 2008

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIAAA-BOG_AA016555
  • K24AA016555 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alcohol Dependence

Clinical Trials on disulfiram plus lorazepam

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe