Alcohol DependencePhase 4NCT00461890
Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
A Phase 4 study testing Injectable Naltrexone in people with Alcohol Dependence and Veterans, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans treated in VA primary care clinics. However, assessment and treatment of alcohol dependence in primary care remains problematic. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence, Veterans
- What is being tested?
- Injectable Naltrexone
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2007
- 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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be males or non-pregnant females between the ages of 18 and 69 who are receiving their primary medical care at the Syracuse VAMC.
- Participants must meet DSM-IV diagnostic criteria for current alcohol dependence.
- Participants must report drinking within the thirty days prior to study entry.
- Participants must receive approval from their primary care provider for study participation.
- Participants must be willing to consider accepting at least one of the two treatment conditions.
Who cannot join
- Participants with a current DSM-IV diagnosis of current opioid abuse or dependence, or in opioid withdrawal
- AST level is greater than 3 times the upper limit of the normal range
- Participants with a medical condition requiring opioid medication or a severe allergy to naltrexone
- Participants who received outpatient treatment at the Syracuse VA Chemical Dependence Clinic in the past 90 days
- Any unstable medical or psychiatric conditions in the judgment of the principal investigator or the participants primary care provider
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans treated in VA primary care clinics. However, assessment and treatment of alcohol dependence in primary care remains problematic. Assessment of veterans with positive alcohol use screens may not always be completed and referrals to specialty care may not always be made. Moreover, the use of medications for alcohol dependence among veterans is rare, despite VA treatment guidelines that recommend such use. Finally, when medications are prescribed, patients may have difficulties with adherence.
The primary aim of this study is to assess the feasibility of long-acting injectable naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
- Conditions
- Alcohol Dependence, Veterans
- Being tested
- Injectable Naltrexone
- Keywords
- Alcohol, Veterans, Primary Care, Naltrexone
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable NaltrexoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
Secondary outcomes (1)
Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionDec 2007
- Study completionDec 2007
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.
- 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
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Principal investigator, Steven Batki, M.D., State University of New York - Upstate Medical University
- Investigators
- Steven L Batki, M.D., Principal investigator, Executive Director VA Center for Integrated Healthcare, Syracuse VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461890
- Sponsor's protocol ID
- Syracuse VA IRB #00364
- Status last verified
- Oct 2011
- First submitted
- 13 Apr 2007
- Last updated
- 24 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
- ClinicalTrials.gov ID
- NCT00461890
- Acronym / sponsor ID
- Syracuse VA IRB #00364
- Conditions
- Alcohol Dependence, Veterans
- Keywords
- Alcohol, Veterans, Primary Care, Naltrexone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Oct 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Apr 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 goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans treated in VA primary care clinics. However, assessment and treatment of alcohol dependence in primary care remains problematic. Assessment of veterans with positive alcohol use screens may not always be completed and referrals to specialty care may not always be made. Moreover, the use of medications for alcohol dependence among veterans is rare, despite VA treatment guidelines that recommend such use. Finally, when medications are prescribed, patients may have difficulties with adherence.
The primary aim of this study is to assess the feasibility of long-acting injectable naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must be males or non-pregnant females between the ages of 18 and 69 who are receiving their primary medical care at the Syracuse VAMC.
- Participants must meet DSM-IV diagnostic criteria for current alcohol dependence.
- Participants must report drinking within the thirty days prior to study entry.
- Participants must receive approval from their primary care provider for study participation.
- Participants must be willing to consider accepting at least one of the two treatment conditions.
Key exclusion criteria (5 listed)
- Participants with a current DSM-IV diagnosis of current opioid abuse or dependence, or in opioid withdrawal
- AST level is greater than 3 times the upper limit of the normal range
- Participants with a medical condition requiring opioid medication or a severe allergy to naltrexone
- Participants who received outpatient treatment at the Syracuse VA Chemical Dependence Clinic in the past 90 days
- Any unstable medical or psychiatric conditions in the judgment of the principal investigator or the participants primary care provider
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 |
|---|---|---|
| Injectable Naltrexone | Drug | – |
Primary outcome
Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
1 secondary outcome
Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 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.
Steven L Batki, M.D. principal investigator
Executive Director VA Center for Integrated Healthcare, Syracuse VA Medical Center
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 Injectable Naltrexone in people with Alcohol Dependence and Veterans, run by State University of New York - Upstate Medical 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Oct 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 was stopped early. Results are not available in the source record.
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?
Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.. 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 24 Oct 2011.