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Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

Primary Purpose

Alcohol Dependence, Anxiety Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

disulfiram plus lorazepam

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring alcohol dependence, alcoholism, anxiety disorder, pharmacotherapy, disulfiram, lorazepam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

University of New Mexico Addiction and Substance Abuse Programs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Disulfiram plus lorazepam

Arm Description

Disulfiram plus lorazepam

Outcomes

Primary Outcome Measures

Treatment Adherence

Completion of 16 weeks of disulfiram treatment

Secondary Outcome Measures

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

As measured by Timeline Followback

Categorical Abstinence (Intent-to-treat Sample)

As measured by timeline followback

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

As measured by Timeline Followback

Categorical Abstinence (Among Those Observed at Week 16)

As measured by timeline followback

Full Information

NCT ID

NCT00721526

First Posted

July 22, 2008

Last Updated

August 10, 2023

Sponsor

University of New Mexico

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT00721526

Brief Title

Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of New Mexico

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Dependence, Anxiety Disorder

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Disulfiram plus lorazepam

Arm Type

Experimental

Arm Description

Disulfiram plus lorazepam

Intervention Type

Drug

Intervention Name(s)

disulfiram plus lorazepam

Intervention Description

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

Primary Outcome Measure Information:

Title

Treatment Adherence

Description

Completion of 16 weeks of disulfiram treatment

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

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

Description

As measured by Timeline Followback

Time Frame

Weeks 13-16 (Last 4 weeks of treatment)

Title

Categorical Abstinence (Intent-to-treat Sample)

Description

As measured by timeline followback

Time Frame

Weeks 13-16 (Last 4 weeks of treatment)

Title

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

Description

As measured by Timeline Followback

Time Frame

Weeks 13-16 (Last 4 weeks of treatment)

Title

Categorical Abstinence (Among Those Observed at Week 16)

Description

As measured by timeline followback

Time Frame

Weeks 13-16 (Last 4 weeks of treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael P. Bogenschutz, M. D.

Organizational Affiliation

University of New Mexico Health Sciences Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of New Mexico Addiction and Substance Abuse Programs

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

12. IPD Sharing Statement

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