Drug Therapy for Alcohol Detoxification

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00000441
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 2002
  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
Endpoint Classification: Efficacy Study
Masking: Double-Blind
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

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00000441     History of Changes
Other Study ID Numbers: NIAAAMAL10761
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Carbamazepine
Lorazepam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Anti-Anxiety Agents
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 20, 2014