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Trial record 53 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Drug Therapy for Alcohol Detoxification

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: NCT00000441
Recruitment Status : Completed
First Posted : November 3, 1999
Last Update Posted : June 24, 2005
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Tracking Information
First Submitted Date  ICMJE November 2, 1999
First Posted Date  ICMJE November 3, 1999
Last Update Posted Date June 24, 2005
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Drug Therapy for Alcohol Detoxification
Official Title  ICMJE Carbamazepine and Lorazepam in Outpatient Detoxification
Brief Summary This project will provide relevant clinical information for primary care practitioners treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo- controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a 1-week posttreatment followup.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • Drug: lorazepam (Ativan)
  • Drug: carbamazepine (Tegretol)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE December 2000
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome.
  • Ability to provide informed consent, complete self-rating questionnaires, and respond to structured clinician-rated instruments.
  • Must live within 50 miles or one hour of the study site and have reliable transportation to the site.
  • Must have a significant other who will provide a collateral report, attend outpatient visits, and be available by telephone.
  • Subjects must be medically stable.
  • Must have a clinical withdrawal assessment prior to study.

Exclusion Criteria:

  • Meets criteria for any other substance dependence syndrome other than alcohol dependence or marijuana abuse.
  • Use of other illicit psychoactive substances (except marijuana) in the last 7 days.
  • Use of pharmaceutical agents within the last 14 days that are known to lower the seizure threshold, augment or decrease the alcohol withdrawal syndrome.
  • History of status epilepticus or two or more seizures occurring within 24- hour period during a previous alcohol withdrawal or other forms of epilepsy.
  • Current major depressive illness, dementia, suicidal or homicidal ideation, or past or present schizophrenia.
  • Acute medical instability as characterized by hepatic encephalopathy, past or present severe liver failure.
  • Diabetes requiring insulin, or severe renal disease.
  • Pregnant females.
  • High blood pressure.
  • Individuals with vomiting who cannot take oral medications at beginning of study or whose vomiting can be controlled only with antiemetic medication.
  • High white blood count, or liver function test that is 3 times higher than normal.
  • Known hypersensitivity or previous adverse reaction to carbamazepine, lorazepam, or other benzodiazepines.
  • Any relevant ECG abnormality which might require hospitalization or greatly interfere with safety during outpatient withdrawal.
  • History of severe gastrointestinal (GI) disease which might render absorption of the medication difficult or produce medical instability of the patient during detoxification which would include active peptic ulcer disease, ulcerative colitis, regional ileitis, or evidence by history or physical examination of GI bleeding.
  • Familial tremor or other neurological condition, determined by history, known to produce tremor.
  • Unable to provide a written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (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 NCT00000441
Other Study ID Numbers  ICMJE NIAAAMAL10761
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Verification Date August 2002

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