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Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Michael Bogenschutz, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00721526
First received: July 22, 2008
Last updated: January 28, 2013
Last verified: January 2013
  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:


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 ]

Enrollment: 45
Study Start Date: August 2009
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
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, see Learn About Clinical Studies.

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

Locations
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
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 28, 2013
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
Disease
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Pathologic Processes
Substance-Related Disorders
Disulfiram
Lorazepam
Alcohol Deterrents
Anti-Anxiety Agents
Anticonvulsants
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014