COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00721526
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : January 30, 2013
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Michael Bogenschutz, University of New Mexico

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 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 or disease Intervention/treatment Phase
Alcohol Dependence Anxiety Disorder Drug: disulfiram plus lorazepam Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Disulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder
Study Start Date : August 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Disulfiram plus lorazepam
Disulfiram plus lorazepam
Drug: disulfiram plus lorazepam
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily

Primary Outcome Measures :
  1. Percent days abstinent from alcohol [ Time Frame: 16 weeks ]
  2. retention in treatment [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. drinking consequences [ Time Frame: 16 weeks, 24 weeks ]
  2. Percent days abstinent from alcohol [ Time Frame: 24 weeks ]
  3. drinks per drinking day [ Time Frame: 16 weeks, 24 weeks ]
  4. remission status [ Time Frame: 16 weeks, 24 weeks ]
  5. time to first heavy drinking day [ Time Frame: 16 weeks, 24 weeks ]
  6. Hamilton anxiety scale score [ Time Frame: 16 weeks, 24 weeks ]
  7. adverse events [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00721526

Layout table for location information
United States, New Mexico
University of New Mexico Addiction and Substance Abuse Programs
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
University of New Mexico
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Layout table for investigator information
Principal Investigator: Michael P. Bogenschutz, M. D. University of New Mexico Health Sciences Center
Layout table for additonal information
Responsible Party: Michael Bogenschutz, Professor of Psychiatry, University of New Mexico Identifier: NCT00721526    
Other Study ID Numbers: NIAAA-BOG_AA016555
K24AA016555 ( U.S. NIH Grant/Contract )
NIH Grant K24AA016555
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: January 30, 2013
Last Verified: January 2013
Keywords provided by Michael Bogenschutz, University of New Mexico:
alcohol dependence
anxiety disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Anxiety Disorders
Pathologic Processes
Mental Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors