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
Sponsored by
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
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
No
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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Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
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