Alcohol-Related DisordersPhase 1/2NCT02885311
Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
A Phase 1/2 study testing Motivation Enhancement Therapy, Naltrexone and Brief Advice in people with Alcohol-Related Disorders and Alcohol Drinking, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this research study is to develop and test a care model to treat excessive drinking and alcohol use disorders in the primary care setting. The goal of this research study is to increase the identification and treatment of problem drinking in the primary care setting. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Disorders, Alcohol Drinking, Alcoholism
- What is being tested?
- Motivation Enhancement Therapy, Naltrexone and Brief Advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Oct 2018
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exceed NIAAA weekly or daily guidelines
- receive care at the 865 clinic
- are fluent in English
- are willing to provide signed, informed consent to participate
- available to complete research follow-ups
- are able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment
Who cannot join
- Meet DSM-V criteria for drug dependence other than for marijuana or nicotine
- on probation or parole
- have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, severe major depression, etc.) that is likely to require pharmacologic treatment or that is currently treated with psychotropic medication; organic mood or mental disorders, or substantial suicide or violence risk
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to develop and test a care model to treat excessive drinking and alcohol use disorders in the primary care setting. The goal of this research study is to increase the identification and treatment of problem drinking in the primary care setting. Individuals will be asked to participate in this study because routine screening and assessment conducted at your primary care clinic indicates that you have recently exceeded healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.
Read the detailed description
Excessive drinking (ED) and alcohol use disorders (AUD) remain one of the nation's leading public health problems, yet this problem is largely under-recognized and undertreated. Although many people with ED/AUD see a primary care physician annually, there has been limited research and implementation of models to treat ED/AUD in primary care. Important changes in the healthcare system and advances in alcohol research offer new and potentially transformative opportunities to integrate ED/AUD treatment into primary care practices. In particular, these changes have led to the development of new patient-centered, integrated care models that facilitate the treatment behavioral health issues in primary care. Experts have repeatedly called for the development of a chronic care model to treat alcohol problems in primary care, similar to models now used to treat other chronic illnesses, including depression. Yet, research to develop and test such models has been surprisingly limited. The primary aim of this study is to develop and test a chronic care model to treat ED/AUD in the patient-centered model home (PCMH) using the NIH stage model of intervention development. Specifically, using a mixed methods approach, this study proposes to adapt and test the collaborative care (CC) model for depression to treat ED/AUD in a high volume PCMH. Importantly, we will build the CC model onto a Screening, Brief Intervention, and Referral to Treatment (SBIRT) program that is already in place in the PCMH. Notably, this SBIRT model currently refers those with ED/AUD out to specialty treatment providers. The proposed study will be conducted in two phases. Phase I will involve initial adaptation of the CC model for depression. During this phase, relevant depression CC protocols and measures will be adapted for ED/AUD and piloted tested on participants (n = 25) recruited in a PCMH. Phase II will involve model refinement based on iterative cycles of patient and PCMH staff feedback and examination of drinking outcome data. During this phase, participants (n = 60) will be assessed and followed for three months. Iterative development will focus on: 1) utilizing a stepped-care model of treatment which will include outpatient detoxification, behavioral interventions, and medication intervention and management, 2) maximizing patient engagement, and 3) balancing the resource and expertise constraints of treating ED/AUD in a PCMH. Participants in Phases 1 and 2 will be followed at 1 and 3 months and primary outcome data on drinking outcomes will be examined.
- Conditions
- Alcohol-Related Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse, Alcohol Use Disorders
- Being tested
- Motivation Enhancement Therapy, Modified Behavioral Self-Control Therapy, Naltrexone, Brief Advice, Referral to specialty substance use disorder treatment
- Keywords
- Drinking, Excessive drinking, Alcohol use disorders, Primary Care
- Medical subject headings
- Alcohol-Related Disorders, Alcohol Drinking, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation Enhancement TherapyBehavioural
Also called MET
Motivation Enhancement Therapy (MET) similarly allows for goal choice in treatment, and has been shown to be effective in treating a broad spectrum of drinking problems in both abstinent and non-abstinent goal conditions. The unique goals of MET (enhancing intrinsic motivation for change and facilitating development of a self-generated change plan).
Modified Behavioral Self-Control TherapyBehavioural
Also called MBSCT
Motivational Interviewing was developed to increase self-efficacy and motivation for drinking, and Cognitive Behavioral Therapy allows for individuals to develop strategies for drinking reduction. Both are evidence-based interventions that have been combined in previous studies for drinking reduction in problem drinkers.
NaltrexoneDrug
Also called NTX
Participants, who choose medication treatment, will be offered naltrexone (50 mg per day), which is an FDA-Approved medication for alcohol use disorder. According to the package insert for NTX, the medication has been associated with liver toxicity at very high doses (up to 300 mg/day); however, a number of clinical trials and published studies suggest there are few serious adverse effects, including minimal hepatotoxicity, associated with daily dose of 50 mg of naltrexone. Its most common side effects in opioid-free individuals are nausea, vomiting, anxiety, headache, abdominal discomfort, difficulty sleeping, fatigue, irritability, and decreased appetite. A rare serious adverse effect may include minimal liver toxicity, but is more likely to occur at very high doses (300 mg/day).
Brief AdviceBehavioural
Also called BA
Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide.
Referral to specialty substance use disorder treatmentOther
Also called Referral
Participants who present with complex drinking concerns will be referred to specialty substance use disorder treatment. This treatment will be provided in a separate treatment facility that focuses on substance use disorders and will potentially provide a combination of medication management and individual/group behavioral treatment for substance use disorders.
| Study group | Role | What they receive |
|---|---|---|
| At-Risk Drinkers (AR) | Other | AR will receive feedback about their drinking and brief advice along with follow up assessments. Receives: Behavioral: Brief Advice |
| Problem Drinkers (PD) | Other | PD will be offered a choice of either an evidence-based behavioral intervention(Motivational Enhancement Therapy) or medication (Naltrexone) plus medication management. These participants will also receive follow up assessments. Receives: Behavioral: Motivation Enhancement Therapy; Drug: Naltrexone; Behavioral: Brief Advice |
| AD with physiological withdrawal (AD-W) | Other | AD-W will referred to outpatient detoxification as part of standard care, unless medically contraindicated, and will be offered medication (naltrexone) plus medication management as or an evidence-based behavioral intervention (Modified Behavioral Self-Control Therapy [MBSCT]) adapted from our two prior protocols. These participants will also receive follow up assessments. Receives: Behavioral: Modified Behavioral Self-Control Therapy; Drug: Naltrexone; Behavioral: Brief Advice |
| AD with complex presentation (AD-CMPLX) | Other | AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments. Receives: Behavioral: Brief Advice; Other: Referral to specialty substance use disorder treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Change in Drinking
We used to the Timeline Followback Interview to collect the average weekly number of standard drinks of alcohol (about 9 grams) consumed at baseline (8 weeks prior to study enrollment) and during the 12-week treatment period. The minimum score is zero. There is no maximum score. Higher negative scores reflect a greater reduction in drinking and better outcomes.
Measured: Baseline (8 weeks prior to study enrollment) and the 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2018
- Study completionOct 2018
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.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885311
- Sponsor's protocol ID
- 15-0743
- Other IDs
- R34AA024589
- Status last verified
- Oct 2023
- First submitted
- 26 Aug 2016
- Last updated
- 30 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
- ClinicalTrials.gov ID
- NCT02885311
- Acronym / sponsor ID
- 15-0743
- Conditions
- Alcohol-Related Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse, Alcohol Use Disorders
- Keywords
- Drinking, Excessive drinking, Alcohol use disorders, Primary Care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Posted 30 Oct 2023
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 research study is to develop and test a care model to treat excessive drinking and alcohol use disorders in the primary care setting. The goal of this research study is to increase the identification and treatment of problem drinking in the primary care setting. Individuals will be asked to participate in this study because routine screening and assessment conducted at your primary care clinic indicates that you have recently exceeded healthy drinking limits as outlined by the National Institutes of Alcohol and Alcoholism.
Detailed description
Excessive drinking (ED) and alcohol use disorders (AUD) remain one of the nation's leading public health problems, yet this problem is largely under-recognized and undertreated. Although many people with ED/AUD see a primary care physician annually, there has been limited research and implementation of models to treat ED/AUD in primary care. Important changes in the healthcare system and advances in alcohol research offer new and potentially transformative opportunities to integrate ED/AUD treatment into primary care practices. In particular, these changes have led to the development of new patient-centered, integrated care models that facilitate the treatment behavioral health issues in primary care. Experts have repeatedly called for the development of a chronic care model to treat alcohol problems in primary care, similar to models now used to treat other chronic illnesses, including depression. Yet, research to develop and test such models has been surprisingly limited. The primary aim of this study is to develop and test a chronic care model to treat ED/AUD in the patient-centered model home (PCMH) using the NIH stage model of intervention development. Specifically, using a mixed methods approach, this study proposes to adapt and test the collaborative care (CC) model for depression to treat ED/AUD in a high volume PCMH. Importantly, we will build the CC model onto a Screening, Brief Intervention, and Referral to Treatment (SBIRT) program that is already in place in the PCMH. Notably, this SBIRT model currently refers those with ED/AUD out to specialty treatment providers. The proposed study will be conducted in two phases. Phase I will involve initial adaptation of the CC model for depression. During this phase, relevant depression CC protocols and measures will be adapted for ED/AUD and piloted tested on participants (n = 25) recruited in a PCMH. Phase II will involve model refinement based on iterative cycles of patient and PCMH staff feedback and examination of drinking outcome data. During this phase, participants (n = 60) will be assessed and followed for three months. Iterative development will focus on: 1) utilizing a stepped-care model of treatment which will include outpatient detoxification, behavioral interventions, and medication intervention and management, 2) maximizing patient engagement, and 3) balancing the resource and expertise constraints of treating ED/AUD in a PCMH. Participants in Phases 1 and 2 will be followed at 1 and 3 months and primary outcome data on drinking outcomes will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| At-Risk Drinkers (AR) | Other | Behavioral: Brief AdviceAR will receive feedback about their drinking and brief advice along with follow up assessments. |
| Problem Drinkers (PD) | Other | Behavioral: Motivation Enhancement Therapy, Drug: Naltrexone, Behavioral: Brief AdvicePD will be offered a choice of either an evidence-based behavioral intervention(Motivational Enhancement Therapy) or medication (Naltrexone) plus medication management. These participants will also receive follow up assessments. |
| AD with physiological withdrawal (AD-W) | Other | Behavioral: Modified Behavioral Self-Control Therapy, Drug: Naltrexone, Behavioral: Brief AdviceAD-W will referred to outpatient detoxification as part of standard care, unless medically contraindicated, and will be offered medication (naltrexone) plus medication management as or an evidence-based behavioral intervention (Modified Behavioral Self-Control Therapy [MBSCT]) adapted from our two prior protocols. These participants will also receive follow up assessments. |
| AD with complex presentation (AD-CMPLX) | Other | Behavioral: Brief Advice, Other: Referral to specialty substance use disorder treatmentAD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Exceed NIAAA weekly or daily guidelines
- receive care at the 865 clinic
- are fluent in English
- are willing to provide signed, informed consent to participate
- available to complete research follow-ups
Key exclusion criteria (3 listed)
- Meet DSM-V criteria for drug dependence other than for marijuana or nicotine
- on probation or parole
- have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, severe major depression, etc.) that is likely to require pharmacologic treatment or that is currently treated with psychotropic medication; organic mood or mental disorders, or substantial suicide or violence risk
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 |
|---|---|---|
| Motivation Enhancement TherapyAlso: METMotivation Enhancement Therapy (MET) similarly allows for goal choice in treatment, and has been shown to be effective in treating a broad spectrum of drinking problems in both abstinent and non-abstinent goal conditions. The unique goals of MET (enhancing intrinsic motivation for change and facilitating development of a self-generated change plan). | Behavioural | Problem Drinkers (PD) |
| Modified Behavioral Self-Control TherapyAlso: MBSCTMotivational Interviewing was developed to increase self-efficacy and motivation for drinking, and Cognitive Behavioral Therapy allows for individuals to develop strategies for drinking reduction. Both are evidence-based interventions that have been combined in previous studies for drinking reduction in problem drinkers. | Behavioural | AD with physiological withdrawal (AD-W) |
| NaltrexoneAlso: NTXParticipants, who choose medication treatment, will be offered naltrexone (50 mg per day), which is an FDA-Approved medication for alcohol use disorder. According to the package insert for NTX, the medication has been associated with liver toxicity at very high doses (up to 300 mg/day); however, a number of clinical trials and published studies suggest there are few serious adverse effects, including minimal hepatotoxicity, associated with daily dose of 50 mg of naltrexone. Its most common side effects in opioid-free individuals are nausea, vomiting, anxiety, headache, abdominal discomfort, difficulty sleeping, fatigue, irritability, and decreased appetite. A rare serious adverse effect may include minimal liver toxicity, but is more likely to occur at very high doses (300 mg/day). | Drug | AD with physiological withdrawal (AD-W), Problem Drinkers (PD) |
| Brief AdviceAlso: BABrief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide. | Behavioural | AD with complex presentation (AD-CMPLX), AD with physiological withdrawal (AD-W), At-Risk Drinkers (AR), Problem Drinkers (PD) |
| Referral to specialty substance use disorder treatmentAlso: ReferralParticipants who present with complex drinking concerns will be referred to specialty substance use disorder treatment. This treatment will be provided in a separate treatment facility that focuses on substance use disorders and will potentially provide a combination of medication management and individual/group behavioral treatment for substance use disorders. | Other | AD with complex presentation (AD-CMPLX) |
Primary outcome
Weekly Change in Drinking
Time frame: Baseline (8 weeks prior to study enrollment) and the 12-week treatment period
We used to the Timeline Followback Interview to collect the average weekly number of standard drinks of alcohol (about 9 grams) consumed at baseline (8 weeks prior to study enrollment) and during the 12-week treatment period. The minimum score is zero. There is no maximum score. Higher negative scores reflect a greater reduction in drinking and better outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 1/2 study testing Motivation Enhancement Therapy, Naltrexone and Brief Advice in people with Alcohol-Related Disorders and Alcohol Drinking, run by Northwell Health 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 6 inclusion and 3 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 30 Oct 2023. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 30 Oct 2023). 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?
Weekly Change in Drinking (time frame: Baseline (8 weeks prior to study enrollment) and the 12-week treatment period). 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 30 Oct 2023.