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Drug Therapy for Alcohol Detoxification

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000441
First Posted: November 3, 1999
Last Update Posted: December 9, 2005
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.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  Purpose
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.

Condition Intervention Phase
Alcoholism Drug: lorazepam (Ativan) Drug: carbamazepine (Tegretol) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Carbamazepine and Lorazepam in Outpatient Detoxification

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Estimated Study Completion Date: December 2000
  Eligibility

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.


Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00000441


Locations
United States, South Carolina
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  More Information

ClinicalTrials.gov Identifier: NCT00000441     History of Changes
Other Study ID Numbers: NIAAAMAL10761
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: December 9, 2005
Last Verified: August 2002

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lorazepam
Carbamazepine
Anticonvulsants
Antiemetics
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
Antimanic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers