Status:
COMPLETED
Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
Lead Sponsor:
University of New Mexico
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Dependence
Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00721526
Start Date
August 1 2009
End Date
August 1 2012
Last Update
August 30 2023
Active Locations (1)
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1
University of New Mexico Addiction and Substance Abuse Programs
Albuquerque, New Mexico, United States, 87106