Alcohol DependencePhase 4NCT00721526
Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
A Phase 4 study testing disulfiram plus lorazepam in people with Alcohol Dependence and Anxiety Disorder, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, Anxiety Disorder
- What is being tested?
- disulfiram plus lorazepam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Addiction and Substance Abuse Programs
Albuquerque, New Mexico, 87106
About this study
Official title: 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.
- Conditions
- Alcohol Dependence, Anxiety Disorder
- Being tested
- disulfiram plus lorazepam
- Keywords
- alcohol dependence, alcoholism, anxiety disorder, pharmacotherapy, disulfiram, lorazepam
- Medical subject headings
- Alcoholism, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disulfiram plus lorazepamDrug
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
| Study group | Role | What they receive |
|---|---|---|
| Disulfiram plus lorazepam | Experimental | Disulfiram plus lorazepam Receives: Drug: disulfiram plus lorazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence
Completion of 16 weeks of disulfiram treatment
Measured: 16 weeks
Secondary outcomes (4)
Percent Days Abstinent From Alcohol (Intent-to-treat Sample)
As measured by Timeline Followback
Measured: Weeks 13-16 (Last 4 weeks of treatment)
Categorical Abstinence (Intent-to-treat Sample)
As measured by timeline followback
Measured: Weeks 13-16 (Last 4 weeks of treatment)
Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)
As measured by Timeline Followback
Measured: Weeks 13-16 (Last 4 weeks of treatment)
Categorical Abstinence (Among Those Observed at Week 16)
As measured by timeline followback
Measured: Weeks 13-16 (Last 4 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startAug 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michael Bogenschutz, University of New Mexico
- Investigators
- Michael P. Bogenschutz, M. D., Principal investigator, University of New Mexico Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721526
- Sponsor's protocol ID
- NIAAA-BOG_AA016555
- Other IDs
- K24AA016555
- Status last verified
- Aug 2023
- First submitted
- 22 Jul 2008
- Last updated
- 30 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00721526
- Acronym / sponsor ID
- NIAAA-BOG_AA016555
- Conditions
- Alcohol Dependence, Anxiety Disorder
- Keywords
- alcohol dependence, alcoholism, anxiety disorder, pharmacotherapy, disulfiram, lorazepam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Aug 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Jul 2008 (estimated)
- Results
- Posted 30 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Disulfiram plus lorazepam | Experimental | Drug: disulfiram plus lorazepamDisulfiram plus lorazepam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disulfiram plus lorazepamDisulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily | Drug | Disulfiram plus lorazepam |
Primary outcome
Treatment Adherence
Time frame: 16 weeks
Completion of 16 weeks of disulfiram treatment
4 secondary outcomes
Percent Days Abstinent From Alcohol (Intent-to-treat Sample)
Time frame: Weeks 13-16 (Last 4 weeks of treatment)
Categorical Abstinence (Intent-to-treat Sample)
Time frame: 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)
Categorical Abstinence (Among Those Observed at Week 16)
Time frame: Weeks 13-16 (Last 4 weeks of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P. Bogenschutz, M. D. principal investigator
University of New Mexico Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing disulfiram plus lorazepam in people with Alcohol Dependence and Anxiety Disorder, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Adherence (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.