AlcoholismPhase 2NCT00000440
Sertraline and Naltrexone for Alcohol Dependence
A Phase 2 study testing naltrexone (Revia) and sertraline (Zoloft) in people with Alcoholism, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial summary
This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- naltrexone (Revia) and sertraline (Zoloft)
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2002
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meets the criteria for alcohol dependence.
- Abstinent from alcohol for a period of at least 5 days and not greater than 30 days.
- Able to read English and complete study evaluations.
- A stable residence and a telephone to ensure that subjects can be located during the study.
Who cannot join
- Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence.
- Current use of disulfiram (Antabuse) or a MAO Inhibitor.
- Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania).
- Major depression at the time of assessment.
- Previous treatment with naltrexone (Revia) for alcohol dependence.
- Significant underlying medical conditions such as cerebral, renal, thyroid, or cardiac disease.
Show all 9Show fewer
- Abstinent longer than 30 days prior to admission to program.
- Hepatocellular disease or elevated bilirubin levels.
- Females who are pregnant, nursing, or not using a reliable method of birth control.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Sertraline and Naltrexone for Alcohol Dependents
This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).
- Conditions
- Alcoholism
- Being tested
- naltrexone (Revia), sertraline (Zoloft)
- 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
sertraline (Zoloft)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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 124 participants
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
- NCT00000440
- Sponsor's protocol ID
- NIAAAFAR11222
- Status last verified
- Nov 2004
- 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
- Sertraline and Naltrexone for Alcohol Dependents
- ClinicalTrials.gov ID
- NCT00000440
- Acronym / sponsor ID
- NIAAAFAR11222
- Conditions
- Alcoholism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- 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.
This study is a double-blind, placebo-controlled outpatient trial to improve, through the addition of sertraline (Zoloft), the abstinence and relapse rates in alcohol- dependent individuals currently taking naltrexone (Revia).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Meets the criteria for alcohol dependence.
- Abstinent from alcohol for a period of at least 5 days and not greater than 30 days.
- Able to read English and complete study evaluations.
- A stable residence and a telephone to ensure that subjects can be located during the study.
Key exclusion criteria (9 listed)
- Currently meets criteria for substance abuse or dependence with the exception of nicotine dependence.
- Current use of disulfiram (Antabuse) or a MAO Inhibitor.
- Psychotic or otherwise severely psychiatrically disabled (i.e., depressed, suicidal, current mania).
- Major depression at the time of assessment.
- Previous treatment with naltrexone (Revia) for alcohol dependence.
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 | – |
| sertraline (Zoloft) | 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.
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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 2 study testing naltrexone (Revia) and sertraline (Zoloft) 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 4 inclusion and 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.