AlcoholismPhase 4NCT00006449
Post-Treatment Effects of Naltrexone
A Phase 4 study testing naltrexone (Revia), broad spectrum treatment and motivational enhancement therapy in people with Alcoholism, run by Indiana University at 1 site in United States.
Trial summary
The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- naltrexone (Revia), broad spectrum treatment and motivational enhancement therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Jul 2006
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets current diagnosis of alcohol dependence and have been abstinent for a minimum of 3 and maximum of 21 days prior to treatment
- Must be able to participate in an 18-month outpatient study, and live within a one hour or less commute to treatment facility.
- Must be fluent in English.
- Women of childbearing potential must have a negative pregnancy test.
Who cannot join
- Severe hepatic disease or a liver function test greater than 4 times normal.
- Opiate use in the last 14 days or a history of opioid dependence in the past year.
- Pregnant or lactating females who are not using a reliable method of birth control.
- Inability to follow medication instructions and safety precautions.
- Comorbid substance dependence diagnosis in the past 6-months, excluding nicotine or marijuana dependence.
- Use of medications intended to decrease drinking.
- Meets criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute of Psychiatric Research, Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.
- Conditions
- Alcoholism
- Being tested
- naltrexone (Revia), broad spectrum treatment, motivational enhancement therapy
- 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
broad spectrum treatmentBehavioural
motivational enhancement therapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2000 (estimated)
- Study startSep 2000
- Study completionJul 2006
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 Indiana 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
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006449
- Sponsor's protocol ID
- NIAAADAV12696
- Other IDs
- R01AA012696
- Status last verified
- May 2010
- First submitted
- 6 Nov 2000
- Last updated
- 12 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Treatment Effects of Naltrexone
- ClinicalTrials.gov ID
- NCT00006449
- Acronym / sponsor ID
- NIAAADAV12696
- Conditions
- Alcoholism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2000
- Study completion
- Jul 2006
- First posted
- 7 Nov 2000 (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.
The aims of this protocol are to compare 3 and 6 months of naltrexone treatment coupled with two psychotherapies that differ in scope and intensity. The effect of these treatments will be assessed with patients who differ in their psychosocial need and resources at their disposal, and in their level of cravings for alcohol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets current diagnosis of alcohol dependence and have been abstinent for a minimum of 3 and maximum of 21 days prior to treatment
- Must be able to participate in an 18-month outpatient study, and live within a one hour or less commute to treatment facility.
- Must be fluent in English.
- Women of childbearing potential must have a negative pregnancy test.
Key exclusion criteria (7 listed)
- Severe hepatic disease or a liver function test greater than 4 times normal.
- Opiate use in the last 14 days or a history of opioid dependence in the past year.
- Pregnant or lactating females who are not using a reliable method of birth control.
- Inability to follow medication instructions and safety precautions.
- Comorbid substance dependence diagnosis in the past 6-months, excluding nicotine or marijuana 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 | – |
| broad spectrum treatment | Behavioural | – |
| motivational enhancement therapy | Behavioural | – |
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 12 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), broad spectrum treatment and motivational enhancement therapy in people with Alcoholism, run by Indiana 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 7 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 12 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 12 May 2010.