Disulfiram Combined With Lorazapam for Alcohol Dependence and Anxiety Disorder - Full Text View

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00721526

Purpose

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.

Condition	Intervention	Phase
Alcohol Dependence Anxiety Disorder	Drug: disulfiram plus lorazepam	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Disulfiram Combined With Lorazapam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism Anxiety

Drug Information available for: Ethanol Disulfiram Lorazepam

U.S. FDA Resources

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Percent days abstinent from alcohol [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
retention in treatment [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

drinking consequences [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
Percent days abstinent from alcohol [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
drinks per drinking day [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
remission status [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
time to first heavy drinking day [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
Hamilton anxiety scale score [ Time Frame: 16 weeks, 24 weeks ] [ Designated as safety issue: No ]
adverse events [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721526

Contacts

Contact: Michael P. Bogenschutz, M. D.

505-272-8428

mbogenschutz@salud.unm.edu

Locations

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

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Michael P. Bogenschutz, M. D.

University of New Mexico Health Sciences Center

More Information

No publications provided

Responsible Party:	University of new Mexico Health Sciences Center ( Michael P. Bogenschutz, M.D. Professor of Psychiatry )
Study ID Numbers:	NIAAA-BOG_AA016555, NIH Grant K24AA016555
Study First Received:	July 22, 2008
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00721526 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

alcohol dependence
alcoholism
anxiety disorder

pharmacotherapy
disulfiram
lorazepam

Additional relevant MeSH terms:

Disulfiram
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Disorders of Environmental Origin
Lorazepam
Pathologic Processes
Mental Disorders
Therapeutic Uses
Hypnotics and Sedatives
Substance-Related Disorders
Alcohol-Related Disorders

Disease
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Enzyme Inhibitors
Pharmacologic Actions
Anxiety Disorders
Autonomic Agents
Alcoholism
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Alcohol Deterrents

ClinicalTrials.gov processed this record on February 08, 2010