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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

July 22, 2008
January 28, 2013
August 2009
August 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00721526 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
Disulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Alcohol Dependence
  • Anxiety Disorder
Drug: disulfiram plus lorazepam
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
Experimental: Disulfiram plus lorazepam
Disulfiram plus lorazepam
Intervention: Drug: disulfiram plus lorazepam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
August 2012
August 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00721526
NIAAA-BOG_AA016555, K24AA016555, NIH Grant K24AA016555
Yes
Michael Bogenschutz, University of New Mexico
University of New Mexico
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Michael P. Bogenschutz, M. D. University of New Mexico Health Sciences Center
University of New Mexico
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP