Alcohol DependencePhase 4NCT00419315
A Randomized Clinical Trial of Alcohol Care Management
A Phase 4 study testing Alcohol Care Management in people with Alcohol Dependence, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Alcohol Care Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be men and women = 18 years of age;
- meet criteria for alcohol dependence;
- drink more than an average of 2 drinks per day prior to study entry (over the last 60 days);
- have adequate hearing to participate in assessment
Who cannot join
- show no evidence of current abuse or dependence of illicit substances other than marijuana;
- no current hallucinations;
- no current symptoms of mania;
- be relatively cognitively intact
- not actively participate in specialized addition or behavioral health treatment within the prior 12 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210
About this study
Official title: Primary Care Based Disease Management for Alcohol Dependence
A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings.
Read the detailed description
Background: Alcohol dependence is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments less than 20% of individuals with alcohol dependence are actively engaged in treatment. Within the VA system systematic screening was implemented to increase the identification of patients with both abuse and dependence. However, there continues to be a marked discrepancy in the care offered or accessed among those identified with alcohol dependence. Existing treatment guidelines suggest that all persons with dependence receive care in specialty addiction treatment. Data from our center indicate that among those individuals screened in primary care who have AUDIT - C scores of >7, only 30% are formally evaluated with 50% receiving only brief advice and 20% having no evidence of assessment or referral. Of those assessed and referred to specialty care only 60% attend an initial visit and only 33% meet the EPRP performance measure of 2 visits per month for 90 days. This disparity in treatment access exists even though Veterans self report a desire to cut down and readiness to change drinking behaviors. (VA ACQUIP) and a willingness to consider pharmacotherapy.
Aims: Available evidence suggests that primary care may be a key component in the identification of alcohol dependent patients, delivery of initial interventions, and to the success of addiction treatment. Indeed, the vast majority of screening and new case identification occurs within primary care. The primary aims of this proposal are to test the effectiveness of a primary care based Alcohol Care Management (ACM) program and to evaluate the barriers and facilitators to accessing and engaging individuals into treatment. The ACM program uses a Behavioral Health Specialist to deliver care focused on the use of pharmacotherapy in combination with psychosocial support (Medication Management). This model may overcome barriers to care such as frequent intensive visit schedules often required in specialty settings, stigma associated with specialty care or group therapy approaches, access to specialty care in remote areas, and the current focus on a 12 step model of treatment. Secondary aims are to establish the acceptability of primary care based treatments and defining treatment modifiers such as age, barriers, co-occurring depression, and pharmacogenetic response.
- Conditions
- Alcohol Dependence
- Being tested
- Alcohol Care Management, Usual Care
- Keywords
- alcoholism, primary care, treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Care ManagementBehavioural
Care management for alcohol dependence with a focus on pharmacotherapy
Usual CareBehavioural
Usual care included a referral to a specialty addiction treatment program.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol Care Management | Experimental | Care management for alcohol dependence delivered in primary care Receives: Behavioral: Alcohol Care Management |
| Usual Care | Active comparator | Usual care included a referral to specialty addiction treatment Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Engagement
This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.
Measured: 6 months
Secondary outcomes (1)
Percent Days of Heavy Alcohol Use
This is a measure during the 6 month of the percentage of 30 days in which a subject had at least 1 day of heavy drinking as defined by drinking more than 4 standard drinks in a day (3 or more for women).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David W. Oslin, MD, Principal investigator, Philadelphia VA Medical Center, Philadelphia, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00419315
- Sponsor's protocol ID
- IIR 06-058
- Status last verified
- Apr 2015
- First submitted
- 4 Jan 2007
- Last updated
- 12 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Oslin DW, Lynch KG, Maisto SA, Lantinga LJ, McKay JR, Possemato K, Ingram E, Wierzbicki M. A randomized clinical trial of alcohol care management delivered in Department of Veterans Affairs primary care clinics versus specialty addiction treatment. J Gen Intern Med. 2014 Jan;29(1):162-8. doi: 10.1007/s11606-013-2625-8. Epub 2013 Sep 20.
PubMed 24052453Rotenberg JR, Leong SH, Maisto SA, McKay JR, Possemato K, Ingram E, Oslin DW. Post-intervention Durability of Alcohol Care Management: 1-Year Follow-up of a Randomized Controlled Trial. J Gen Intern Med. 2018 Oct;33(10):1626-1628. doi: 10.1007/s11606-018-4567-7. No abstract available.
PubMed 30003479
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Based Disease Management for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00419315
- Acronym / sponsor ID
- IIR 06-058
- Conditions
- Alcohol Dependence
- Keywords
- alcoholism, primary care, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Jan 2007 (estimated)
- Results
- Posted 11 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized study of Alcohol Care Management for the treatment of alcohol dependence in primary care settings.
Detailed description
Background: Alcohol dependence is one of the leading causes of disability worldwide. Despite the availability of efficacious treatments less than 20% of individuals with alcohol dependence are actively engaged in treatment. Within the VA system systematic screening was implemented to increase the identification of patients with both abuse and dependence. However, there continues to be a marked discrepancy in the care offered or accessed among those identified with alcohol dependence. Existing treatment guidelines suggest that all persons with dependence receive care in specialty addiction treatment. Data from our center indicate that among those individuals screened in primary care who have AUDIT - C scores of >7, only 30% are formally evaluated with 50% receiving only brief advice and 20% having no evidence of assessment or referral. Of those assessed and referred to specialty care only 60% attend an initial visit and only 33% meet the EPRP performance measure of 2 visits per month for 90 days. This disparity in treatment access exists even though Veterans self report a desire to cut down and readiness to change drinking behaviors. (VA ACQUIP) and a willingness to consider pharmacotherapy.
Aims: Available evidence suggests that primary care may be a key component in the identification of alcohol dependent patients, delivery of initial interventions, and to the success of addiction treatment. Indeed, the vast majority of screening and new case identification occurs within primary care. The primary aims of this proposal are to test the effectiveness of a primary care based Alcohol Care Management (ACM) program and to evaluate the barriers and facilitators to accessing and engaging individuals into treatment. The ACM program uses a Behavioral Health Specialist to deliver care focused on the use of pharmacotherapy in combination with psychosocial support (Medication Management). This model may overcome barriers to care such as frequent intensive visit schedules often required in specialty settings, stigma associated with specialty care or group therapy approaches, access to specialty care in remote areas, and the current focus on a 12 step model of treatment. Secondary aims are to establish the acceptability of primary care based treatments and defining treatment modifiers such as age, barriers, co-occurring depression, and pharmacogenetic response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol Care Management | Experimental | Behavioral: Alcohol Care ManagementCare management for alcohol dependence delivered in primary care |
| Usual Care | Active comparator | Behavioral: Usual CareUsual care included a referral to specialty addiction treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be men and women = 18 years of age;
- meet criteria for alcohol dependence;
- drink more than an average of 2 drinks per day prior to study entry (over the last 60 days);
- have adequate hearing to participate in assessment
Key exclusion criteria (5 listed)
- show no evidence of current abuse or dependence of illicit substances other than marijuana;
- no current hallucinations;
- no current symptoms of mania;
- be relatively cognitively intact
- not actively participate in specialized addition or behavioral health treatment within the prior 12 months
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 |
|---|---|---|
| Alcohol Care ManagementCare management for alcohol dependence with a focus on pharmacotherapy | Behavioural | Alcohol Care Management |
| Usual CareUsual care included a referral to a specialty addiction treatment program. | Behavioural | Usual Care |
Primary outcome
Treatment Engagement
Time frame: 6 months
This measured the percentage of subjects who attended at least 2 clinical addiction sessions in a given month. The outcome presented is the percentage during the 6th month of the trial.
1 secondary outcome
Percent Days of Heavy Alcohol Use
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24052453Oslin DW, Lynch KG, Maisto SA, Lantinga LJ, McKay JR, Possemato K, Ingram E, Wierzbicki M. A randomized clinical trial of alcohol care management delivered in Department of Veterans Affairs primary care clinics versus specialty addiction treatment. J Gen Intern Med. 2014 Jan;29(1):162-8. doi: 10.1007/s11606-013-2625-8. Epub 2013 Sep 20.
- Derived from this study: PubMed 30003479Rotenberg JR, Leong SH, Maisto SA, McKay JR, Possemato K, Ingram E, Oslin DW. Post-intervention Durability of Alcohol Care Management: 1-Year Follow-up of a Randomized Controlled Trial. J Gen Intern Med. 2018 Oct;33(10):1626-1628. doi: 10.1007/s11606-018-4567-7. No abstract available.
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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.
David W. Oslin, MD principal investigator
Philadelphia VA Medical Center, Philadelphia, PA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alcohol Care Management in people with Alcohol Dependence, run by US Department of Veterans Affairs at 2 sites 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 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: finished, as of the sponsor's last update on 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 11 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Engagement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00419315, which also lists 2 linked publications.
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 2015.