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

Sponsor:	University of New Mexico
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):	Michael Bogenschutz, University of New Mexico
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 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Disulfiram Combined With Lorazepam 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: Disulfiram Lorazepam

U.S. FDA Resources

Further study details as provided by University of New Mexico:

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:	August 2012
Estimated Primary Completion Date:	August 2012 (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	Recruiting
Albuquerque, New Mexico, United States, 87106
Principal Investigator: Michael P. Bogenschutz, M. D.

Sponsors and Collaborators

University of New Mexico

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:	Michael Bogenschutz, Professor of Psychiatry, University of New Mexico
ClinicalTrials.gov Identifier:	NCT00721526 History of Changes
Other Study ID Numbers:	NIAAA-BOG_AA016555, K24AA016555, NIH Grant K24AA016555
Study First Received:	July 22, 2008
Last Updated:	January 31, 2012
Health Authority:	United States: Federal Government

Keywords provided by University of New Mexico:

alcohol dependence
alcoholism
anxiety disorder

pharmacotherapy
disulfiram
lorazepam

Additional relevant MeSH terms:

Alcoholism
Anxiety Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Disulfiram
Lorazepam
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2012