AlcoholismPhase 4NCT00000455
Naltrexone for Early Problem Drinkers
A Phase 4 study testing naltrexone in people with Alcoholism, run by UConn Health at 1 site in United States.
Trial summary
Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence. 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
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 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
- Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence).
- Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women.
- Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
- Willing to provide a collateral informant for interviews regarding the patient's drinking during the study.
- A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment.
- Willing to provide a signed informed consent to participate in the study.
Who cannot join
- Have a current clinically significant physical disease or abnormality.
- Have a serious psychiatric illness.
- Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence.
- A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms.
- Used opioids or other psychoactive medications regularly in the month prior to study enrollment.
- History of hypersensitivity to naltrexone (Revia).
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: Targeted Naltrexone for Early Problem Drinkers
Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence.
Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.
- Conditions
- Alcoholism
- Being tested
- naltrexone
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexoneDrug
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 completionSep 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
- Allocation
- Randomised
- Enrolment
- 160 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
- NCT00000455
- Sponsor's protocol ID
- NIAAAKRA11062
- Other IDs
- R01AA011062
- Status last verified
- Jun 2011
- First submitted
- 2 Nov 1999
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- 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
- Targeted Naltrexone for Early Problem Drinkers
- ClinicalTrials.gov ID
- NCT00000455
- Acronym / sponsor ID
- NIAAAKRA11062
- Conditions
- Alcoholism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study completion
- Sep 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.
Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence.
Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Limited to early problem drinkers (i.e., those with no more than mild alcohol dependence).
- Have an average weekly alcohol consumption of greater than or equal to 24 standard drinks for men and 18 standard drinks for women.
- Able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment.
- Willing to provide a collateral informant for interviews regarding the patient's drinking during the study.
- A woman of child-bearing potential must be non-lactating, practicing a reliable method of birth control, and have a negative pregnancy test prior to initiation of treatment.
Key exclusion criteria (6 listed)
- Have a current clinically significant physical disease or abnormality.
- Have a serious psychiatric illness.
- Have a current diagnosis of drug dependence (other than nicotine dependence) or a lifetime diagnosis of opioid dependence.
- A current diagnosis of alcohol dependence that is moderate or greater in severity or a history of alcohol withdrawal, or recurrent use of alcohol to alleviate alcohol withdrawal symptoms.
- Used opioids or other psychoactive medications regularly in the month prior to study enrollment.
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 | 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 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 6 inclusion and 6 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.