Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721526
• Other study ID #: NIAAA-BOG_AA016555
• Secondary ID: K24AA016555
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2023
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Anxiety Disorder
• Anxiety Disorders

Intervention

Drug:
• disulfiram plus lorazepam
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily

Locations

Country	Name	City	State
United States	University of New Mexico Addiction and Substance Abuse Programs	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Adherence	Completion of 16 weeks of disulfiram treatment	16 weeks
Secondary	Percent Days Abstinent From Alcohol (Intent-to-treat Sample)	As measured by Timeline Followback	Weeks 13-16 (Last 4 weeks of treatment)
Secondary	Categorical Abstinence (Intent-to-treat Sample)	As measured by timeline followback	Weeks 13-16 (Last 4 weeks of treatment)
Secondary	Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)	As measured by Timeline Followback	Weeks 13-16 (Last 4 weeks of treatment)
Secondary	Categorical Abstinence (Among Those Observed at Week 16)	As measured by timeline followback	Weeks 13-16 (Last 4 weeks of treatment)