CompletedNCT00721526Updated Aug 30, 2023Results posted

Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

A Phase 4 interventional study of disulfiram plus lorazepam in Alcohol Dependence and Anxiety Disorder, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by University of New Mexico · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 41
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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 studied

Alcohol Dependence
Anxiety Disorder

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Keywords

alcohol dependence
alcoholism
anxiety disorder
pharmacotherapy
disulfiram
lorazepam

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 41 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

University of New Mexico is the lead sponsor of 306 studies on the registry; 28 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 41 participants (actual)

Study arms

Experimental
Disulfiram plus lorazepam
Disulfiram plus lorazepam
Drug: disulfiram plus lorazepam

Interventions

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

What researchers measure

Primary outcomes

Treatment Adherence
Completion of 16 weeks of disulfiram treatment
Time frame: 16 weeks

Secondary outcomes

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

Results

Posted Aug 30, 2023

Participant flow

Participant flow — Overall Study
Milestone	Disulfiram Plus Lorazepam
Started	41
Received study medication	40
Completed week 1 follow-up	38
Completed week 2 follow-up	37
Completed week 4 follow-up	36
Completed week 6 follow-up	35
Completed week 8 follow-up	32
Completed week 10 follow-up	29
Completed week 12 follow-up	27
Completed week 16 follow-up	26
Completed	20
Not completed	21

Outcome measures

PrimaryTreatment Adherence

Completion of 16 weeks of disulfiram treatment

Time frame:: 16 weeks
Reported as:: Count of participants · Participants

Treatment Adherence
Participants	Disulfiram Plus Lorazepam
Treatment Adherence	15

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

As measured by Timeline Followback

Time frame:: Weeks 13-16 (Last 4 weeks of treatment)
Reported as:: Mean · percentage of days abstinent

Percent Days Abstinent From Alcohol (Intent-to-treat Sample)
percentage of days abstinent	Disulfiram Plus Lorazepam
Percent Days Abstinent From Alcohol (Intent-to-treat Sample)	65.14 ± 41.004

SecondaryCategorical Abstinence (Intent-to-treat Sample)

As measured by timeline followback

Time frame:: Weeks 13-16 (Last 4 weeks of treatment)
Reported as:: Count of participants · Participants

Categorical Abstinence (Intent-to-treat Sample)
Participants	Disulfiram Plus Lorazepam
Categorical Abstinence (Intent-to-treat Sample)	18

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

As measured by Timeline Followback

Time frame:: Weeks 13-16 (Last 4 weeks of treatment)
Reported as:: Mean · Percent

Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)
Percent	Disulfiram Plus Lorazepam
Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)	87.00 ± 29.569

SecondaryCategorical Abstinence (Among Those Observed at Week 16)

As measured by timeline followback

Time frame:: Weeks 13-16 (Last 4 weeks of treatment)
Reported as:: Count of participants · Participants

Categorical Abstinence (Among Those Observed at Week 16)
Participants	Disulfiram Plus Lorazepam
Categorical Abstinence (Among Those Observed at Week 16)	18

Adverse events

Collected over 24 weeks following first administration of study medication. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Disulfiram Plus Lorazepam	0/40 (0%)	1/40 (2.5%)	28/40 (70%)

Most frequent serious events

Most frequent serious events
Event	Disulfiram Plus Lorazepam
Confusional statePsychiatric disorders	1/40

Most frequent other events

Showing 10 of 35

Most frequent other events
Event	Disulfiram Plus Lorazepam
Alcohol intoleranceMetabolism and nutrition disorders	12/40
PainGeneral disorders	3/40
Transaminases increasedInvestigations	3/40
ArthralgiaMusculoskeletal and connective tissue disorders	3/40
Abdominal painGastrointestinal disorders	2/40
Back painMusculoskeletal and connective tissue disorders	2/40
MyalgiaMusculoskeletal and connective tissue disorders	2/40
HeadacheNervous system disorders	2/40
ApathyPsychiatric disorders	2/40
InsomniaPsychiatric disorders	2/40

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Disulfiram Plus Lorazepam
Mean	41.66 ± 13.07

Sex: Female, Male
Sex: Female, Male(Participants)	Disulfiram Plus Lorazepam
Female	25
Male	16

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Disulfiram Plus Lorazepam
Non-Hispanic White	20
Hispanic	16
Other	5

Region of Enrollment
Region of Enrollment(participants)	Disulfiram Plus Lorazepam
United States	41

Baseline proportion abstinent days
Baseline proportion abstinent days(Percent)	Disulfiram Plus Lorazepam
Mean	0.32 ± 0.31

Baseline drinks per drinking day
Baseline drinks per drinking day(Standard Drinks)	Disulfiram Plus Lorazepam
Mean	16.12 ± 10.97

Baseline estimated peak blood alcohol level
Baseline estimated peak blood alcohol level(percent (mass/volume))	Disulfiram Plus Lorazepam
Mean	0.34 ± 0.24

Study locations

1 site

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00721526
Lead sponsor: University of New Mexico
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party: Michael Bogenschutz (Professor of Psychiatry, University of New Mexico) — Principal investigator
First posted: Jul 24, 2008
Start date: Aug 2009
Primary completion: Aug 2012
Completion: Aug 2012
Results posted: Aug 30, 2023
Last update: Aug 30, 2023

Study contacts

Michael P. Bogenschutz, M. D.

principal investigator · University of New Mexico Health Sciences Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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