AlcoholismPhase 4NCT00000441
Drug Therapy for Alcohol Detoxification
A Phase 4 study testing lorazepam (Ativan) and carbamazepine (Tegretol) in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- lorazepam (Ativan) and carbamazepine (Tegretol)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2000
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Carbamazepine and Lorazepam in Outpatient Detoxification
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.
- Conditions
- Alcoholism
- Being tested
- lorazepam (Ativan), carbamazepine (Tegretol)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorazepam (Ativan)Drug
carbamazepine (Tegretol)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 1999 (estimated)
- Study completionDec 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000441
- Sponsor's protocol ID
- NIAAAMAL10761
- Status last verified
- Aug 2002
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbamazepine and Lorazepam in Outpatient Detoxification
- ClinicalTrials.gov ID
- NCT00000441
- Acronym / sponsor ID
- NIAAAMAL10761
- Conditions
- Alcoholism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study completion
- Dec 2000
- First posted
- 3 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lorazepam (Ativan) | Drug | – |
| carbamazepine (Tegretol) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
Related trials for Alcoholism
Active, not recruitingPhase 2
Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
Connecting Online Military Personnel to Alcohol Harm-reducing Smartphone Support Study
Alcohol Use Disorder (AUD)
RecruitingPhase 4
Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lorazepam (Ativan) and carbamazepine (Tegretol) in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.