Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 46 for:    disulfiram

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.
 
ClinicalTrials.gov Identifier: NCT00721526
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : January 30, 2013
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Michael Bogenschutz, University of New Mexico

Tracking Information
First Submitted Date  ICMJE July 22, 2008
First Posted Date  ICMJE July 24, 2008
Last Update Posted Date January 30, 2013
Study Start Date  ICMJE August 2009
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2008)
  • Percent days abstinent from alcohol [ Time Frame: 16 weeks ]
  • retention in treatment [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00721526 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2008)
  • drinking consequences [ Time Frame: 16 weeks, 24 weeks ]
  • Percent days abstinent from alcohol [ Time Frame: 24 weeks ]
  • drinks per drinking day [ Time Frame: 16 weeks, 24 weeks ]
  • remission status [ Time Frame: 16 weeks, 24 weeks ]
  • time to first heavy drinking day [ Time Frame: 16 weeks, 24 weeks ]
  • Hamilton anxiety scale score [ Time Frame: 16 weeks, 24 weeks ]
  • adverse events [ Time Frame: 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
Official Title  ICMJE Disulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Dependence
  • Anxiety Disorder
Intervention  ICMJE Drug: disulfiram plus lorazepam
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
Study Arms  ICMJE Experimental: Disulfiram plus lorazepam
Disulfiram plus lorazepam
Intervention: Drug: disulfiram plus lorazepam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2013)
45
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2008)
40
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00721526
Other Study ID Numbers  ICMJE NIAAA-BOG_AA016555
K24AA016555 ( U.S. NIH Grant/Contract )
NIH Grant K24AA016555
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Bogenschutz, University of New Mexico
Study Sponsor  ICMJE University of New Mexico
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Michael P. Bogenschutz, M. D. University of New Mexico Health Sciences Center
PRS Account University of New Mexico
Verification Date January 2013

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