AlcoholismPhase 4NCT00000442
Naltrexone for Relapse Prevention
A Phase 4 study testing naltrexone (Revia) in people with Alcoholism, run by UConn Health at 1 site in United States.
Trial summary
This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- naltrexone (Revia)
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Dec 2002
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets criteria for alcohol dependence.
- Abstinent from alcohol for a period of at least 3 days prior to beginning of study.
- Able to read English and complete study evaluations.
- Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.
Who cannot join
- Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.
- Prior history of opioid dependence.
- Regular use of psychoactive drugs including anxiolytics and antidepressants.
- Prior treatment with naltrexone.
- Current use of disulfiram.
- Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania).
- Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease.
- Abstinent longer than 28 days prior to randomization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, University of Pennsylvania
Philadelphia, Pennsylvania, 19103
About this study
Official title: Etiology and Treatment of Alcohol Dependence
This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.
- 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 completionDec 2002
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
- Intervention model
- Parallel groups
- Enrolment
- 57 participants
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000442
- Sponsor's protocol ID
- NIAAAKRA3510
- Other IDs
- P50AA003510
- Status last verified
- Jun 2011
- First submitted
- 2 Nov 1999
- Last updated
- 20 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology and Treatment of Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00000442
- Acronym / sponsor ID
- NIAAAKRA3510
- Conditions
- Alcoholism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study completion
- Dec 2002
- 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 is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets criteria for alcohol dependence.
- Abstinent from alcohol for a period of at least 3 days prior to beginning of study.
- Able to read English and complete study evaluations.
- Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.
Key exclusion criteria (8 listed)
- Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.
- Prior history of opioid dependence.
- Regular use of psychoactive drugs including anxiolytics and antidepressants.
- Prior treatment with naltrexone.
- Current use of disulfiram.
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 20 Jun 2011.
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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 UConn Health 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 4 inclusion and 8 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 20 Jun 2011. 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 20 Jun 2011; AzTrials last refreshed its copy on 2 Nov 2026.