AlcoholismPhase 4NCT00000438
Naltrexone Treatment for Alcoholism
A Phase 4 study testing naltrexone (Revia) in people with Alcoholism, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- naltrexone (Revia)
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Mar 2003
- 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 30 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for alcohol dependence.
- Committed to alcohol abstinence as a treatment goal.
- Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.
Who cannot join
- Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
- Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
- Females who are pregnant, lactating, or not using a reliable method of contraception.
- Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
- Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
- Have a history of severe allergies, multiple adverse drug reactions or known allergy to naltrexone.
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- Vocabulary below the 5th grade reading level.
- Abnormal MRI scan.
- HIV infection due to the neurological sequelae.
- Significant central nervous system diseases.
- Seizure disorder or history of closed head trauma.
- Neuroendocrine disorders.
- Treatment with opiates within the last six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Naltrexone Treatment for Alcoholism: Predicting Outcome
This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.
- Conditions
- Alcoholism
- Being tested
- naltrexone (Revia)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexone (Revia)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 completionMar 2003
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.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Enrolment
- 192 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000438
- Sponsor's protocol ID
- NIAAAMCC11855
- Other IDs
- R01AA011855
- Status last verified
- May 2010
- First submitted
- 2 Nov 1999
- Last updated
- 14 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone Treatment for Alcoholism: Predicting Outcome
- ClinicalTrials.gov ID
- NCT00000438
- Acronym / sponsor ID
- NIAAAMCC11855
- Conditions
- Alcoholism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study completion
- Mar 2003
- 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 study will evaluate the effectiveness of the medication naltrexone (Revia) for treating alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge, individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or a placebo. This part of the study will last 12 weeks, with regular measurements of drinking level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Meets criteria for alcohol dependence.
- Committed to alcohol abstinence as a treatment goal.
- Individuals will be required to identify two family members or close friends who are knowledgeable about their location, drinking behavior, and psychosocial status.
Key exclusion criteria (13 listed)
- Meets criteria for any other psychoactive substance use disorder (excluding nicotine and caffeine).
- Meets criteria for a major psychiatric disorder and are in need of or currently undergoing pharmacotherapy.
- Females who are pregnant, lactating, or not using a reliable method of contraception.
- Currently experiencing a serious medical condition that would place them at risk or interfere with study participation.
- Experiencing acute hepatitis or liver failure or whose liver function test is more than 3 times normal.
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 |
|---|---|---|
| naltrexone (Revia) | 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 14 May 2010.
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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 naltrexone (Revia) in people with Alcoholism, run by Johns Hopkins University 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 3 inclusion and 13 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 14 May 2010. 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 14 May 2010; AzTrials last refreshed its copy on 3 Nov 2026.