Drug Therapy for Alcohol Detoxification

Alcoholism Clinical Trial

Official title:

Carbamazepine and Lorazepam in Outpatient Detoxification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000441
• Other study ID #: NIAAAMAL10761
• Status: Completed
• Phase: Phase 4
• First received: November 2, 1999
• Last updated: June 23, 2005
• Est. completion date: December 2000

Study information

• Verified date: August 2002
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• lorazepam (Ativan)

• carbamazepine (Tegretol)

Locations

Country	Name	City	State
United States	Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,