AlcoholismPhase 2NCT00000451
Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)
A Phase 2 study testing sertraline and naltrexone in people with Alcoholism and Alcohol Dependence, run by Yale University at 1 site in United States.
Trial summary
This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcoholism, Alcohol Dependence
- What is being tested?
- sertraline and naltrexone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Nov 2005
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alaska Native having biological Alaska Native ancestry.
- Meets criteria for alcohol dependence.
- Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
- Stable residence to ensure that subjects can be located during the study.
Who cannot join
- Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
- Current use of disulfiram.
- Psychotic or otherwise severely psychiatrically disabled.
- Use of other psychotropic medications including antidepressants and anxiolytics.
- Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
- Hepatocellular disease or elevated bilirubin levels.
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- Females who are pregnant, nursing, or not using a reliable method of birth control.
- Probation or parole requirements that might interfere with participation in the study.
- Involvement in alcohol treatment other than provided by the study or AA.
- Use of monoamine oxidase inhibitors in the past month.
- Current use of Type 1C antiarrhythmics propafenone and flecainide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives
This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.
- Conditions
- Alcoholism, Alcohol Dependence
- Being tested
- sertraline, naltrexone
- Keywords
- Alcoholism, Alcohol Dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called Zoloft
16 week outpatient study
naltrexoneDrug
Also called Revia
16 week outpatient study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Naltrexone plus Sertraline Receives: Drug: naltrexone |
| 2 | Experimental | Naltrexone alone Receives: Drug: sertraline; Drug: naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days abstinent
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 startJan 2003
- Primary completionAug 2005
- Study completionNov 2005
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 Yale 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Investigators
- Dr. Stephanie O'Malley, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000451
- Sponsor's protocol ID
- NIAAAOMA12028
- Other IDs
- R01AA012028
- Status last verified
- Jan 2013
- First submitted
- 2 Nov 1999
- Last updated
- 29 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naltrexone and SSRI Therapy for Alcohol Dependence in Alaska Natives
- ClinicalTrials.gov ID
- NCT00000451
- Acronym / sponsor ID
- NIAAAOMA12028
- Conditions
- Alcoholism, Alcohol Dependence
- Keywords
- Alcoholism, Alcohol Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2003
- Primary completion
- Aug 2005 (actual)
- Study completion
- Nov 2005 (actual)
- 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 assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: naltrexoneNaltrexone plus Sertraline |
| 2 | Experimental | Drug: sertraline, Drug: naltrexoneNaltrexone alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Alaska Native having biological Alaska Native ancestry.
- Meets criteria for alcohol dependence.
- Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.
- Stable residence to ensure that subjects can be located during the study.
Key exclusion criteria (11 listed)
- Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.
- Current use of disulfiram.
- Psychotic or otherwise severely psychiatrically disabled.
- Use of other psychotropic medications including antidepressants and anxiolytics.
- Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.
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 |
|---|---|---|
| sertralineAlso: Zoloft16 week outpatient study | Drug | 2 |
| naltrexoneAlso: Revia16 week outpatient study | Drug | 1, 2 |
Primary outcome
Days abstinent
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 29 Jan 2013.
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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.
Dr. Stephanie O'Malley principal investigator
Yale University
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 sertraline and naltrexone in people with Alcoholism and Alcohol Dependence, run by Yale 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 4 inclusion and 11 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 29 Jan 2013. 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.
What does the primary outcome measure?
Days abstinent. It is what the study was designed to measure, not a finding.
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 29 Jan 2013.