Alcohol DependencePhase 2RITANCT00523133
Research on Individualized Treatment for Alcoholism
A Phase 2 study testing naltrexone, Broad Spectrum Treatment and Motivational Enhancement Treatment in people with Alcohol Dependence, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study was to compare the effects of two psychosocial treatments that differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking behaviors in alcohol dependent patients. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- naltrexone, Broad Spectrum Treatment and Motivational Enhancement Treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 185 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Jul 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women between the ages of 21-65
- current DSM-IV diagnosis of alcohol dependence
- abstinent for a minimum of 3 and maximum of 21 days prior to treatment initiation
- able to participate in an 18-month outpatient study
- live within a one hour or less commute to Fairbanks
- fluent in English
- women of child-bearing potential must have a negative pregnancy test and use effective contraceptive methods.
- score as contemplators or greater on the Readiness For Change Scale
Who cannot join
- severe hepatic disease (gGGT, SGOT or other liver functions greater than 4 times normal)
- opiate use (for any reason) in the last 14 days or a history of opioid dependence in the past year
- pregnant or lactating females or those unwilling to use birth control
- inability, according to the opinion of the interviewer, to follow medication instructions and safety precautions
- comorbid substance dependence (but not abuse) diagnosis in the past 6 months, excluding nicotine or marijuana dependence
- concomitant use of medications intended to decrease drinking (e.g. disulfiram)
- meeting current DSM criteria for bipolar disorder, schizophrenia, bulimia/anorexia, dementia, major depression
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospital, Psychiatry Outpatient Clinic
Indianapolis, Indiana, 46202
About this study
Official title: Posttreatment Effects of Naltrexone
The purpose of this study was to compare the effects of two psychosocial treatments that differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking behaviors in alcohol dependent patients.
- Conditions
- Alcohol Dependence
- Being tested
- naltrexone, Broad Spectrum Treatment, Motivational Enhancement Treatment
- Keywords
- alcoholism, naltrexone, 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.
naltrexoneDrug
50 mg naltrexone daily for 3 months
naltrexoneDrug
50 mg of naltrexone daily for 6 months
Broad Spectrum TreatmentBehavioural
8-14, one hour sessions over 6 months
Motivational Enhancement TreatmentBehavioural
4, 20 minute sessions over 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Days Abstinent
Measured: 18 months
Secondary outcomes (1)
Percent Heavy Drinking Days
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startSep 2000
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- VA Boston Healthcare System, Brown University, George Washington University
- Investigators
- Dena Davidson, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523133
- Sponsor's protocol ID
- R01AA012696-01A1
- Acronym
- RITA
- Status last verified
- Aug 2007
- First submitted
- 30 Aug 2007
- Last updated
- 31 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posttreatment Effects of Naltrexone
- ClinicalTrials.gov ID
- NCT00523133
- Acronym / sponsor ID
- RITA / R01AA012696-01A1
- Conditions
- Alcohol Dependence
- Keywords
- alcoholism, naltrexone, motivational enhancement therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- VA Boston Healthcare System, Brown University, George Washington University
- Study start
- Sep 2000
- Study completion
- Jul 2005 (actual)
- First posted
- 31 Aug 2007 (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 purpose of this study was to compare the effects of two psychosocial treatments that differed in scope and intensity (Broad Spectrum Treatment and Motivational Enhancement Treatment) combined with 3 or 6 months of treatment with naltrexone on alcohol drinking behaviors in alcohol dependent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- men and women between the ages of 21-65
- current DSM-IV diagnosis of alcohol dependence
- abstinent for a minimum of 3 and maximum of 21 days prior to treatment initiation
- able to participate in an 18-month outpatient study
- live within a one hour or less commute to Fairbanks
Key exclusion criteria (7 listed)
- severe hepatic disease (gGGT, SGOT or other liver functions greater than 4 times normal)
- opiate use (for any reason) in the last 14 days or a history of opioid dependence in the past year
- pregnant or lactating females or those unwilling to use birth control
- inability, according to the opinion of the interviewer, to follow medication instructions and safety precautions
- comorbid substance dependence (but not abuse) 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 |
|---|---|---|
| naltrexone50 mg naltrexone daily for 3 months | Drug | – |
| naltrexone50 mg of naltrexone daily for 6 months | Drug | – |
| Broad Spectrum Treatment8-14, one hour sessions over 6 months | Behavioural | – |
| Motivational Enhancement Treatment4, 20 minute sessions over 3 months | Behavioural | – |
Primary outcome
Percent Days Abstinent
Time frame: 18 months
1 secondary outcome
Percent Heavy Drinking Days
Time frame: 18 months
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 31 Aug 2007.
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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.
Dena Davidson, PhD principal investigator
Indiana 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 naltrexone, Broad Spectrum Treatment and Motivational Enhancement Treatment in people with Alcohol Dependence, 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 8 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 31 Aug 2007. 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?
Percent Days Abstinent (time frame: 18 months). 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 31 Aug 2007.