Disulfiram Combined With Lorazapam for Alcohol Dependence and Anxiety Disorder
Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence; Anxiety Disorder
Intervention: disulfiram plus lorazepam (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA) Official(s) and/or principal investigator(s):
Michael P. Bogenschutz, M. D., Principal Investigator, Affiliation: University of New Mexico Health Sciences Center
Overall contact:
Michael P. Bogenschutz, M. D., Phone: 505-272-8428, Email: mbogenschutz@salud.unm.edu
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.
Clinical Details
Official title: Disulfiram Combined With Lorazapam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Percent days abstinent from alcoholretention in treatment
Secondary outcome: drinking consequencesPercent days abstinent from alcohol drinks per drinking day remission status time to first heavy drinking day Hamilton anxiety scale score adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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).
Locations and Contacts
Michael P. Bogenschutz, M. D., Phone: 505-272-8428, Email: mbogenschutz@salud.unm.edu
University of New Mexico Addiction and Substance Abuse Programs, Albuquerque, New Mexico 87106, United States
Additional Information
Starting date: August 2009
Ending date: April 2011
Last updated: July 22, 2009
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