search
Back to results

Drug Therapy for Alcohol Detoxification

Primary Purpose

Alcoholism

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lorazepam (Ativan)
carbamazepine (Tegretol)
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000441
Brief Title
Drug Therapy for Alcohol Detoxification
Official Title
Carbamazepine and Lorazepam in Outpatient Detoxification
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lorazepam (Ativan)
Intervention Type
Drug
Intervention Name(s)
carbamazepine (Tegretol)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Drug Therapy for Alcohol Detoxification

We'll reach out to this number within 24 hrs