Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
2 other identifiers
interventional
27
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedResults Posted
Study results publicly available
October 30, 2023
CompletedOctober 30, 2023
October 1, 2023
1.7 years
August 26, 2016
November 11, 2022
October 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (8 weeks prior to study enrollment) and the 12-week treatment period
Study Arms (4)
At-Risk Drinkers (AR)
OTHERAR will receive feedback about their drinking and brief advice along with follow up assessments.
Problem Drinkers (PD)
OTHERPD 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)
OTHERAD-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)
OTHERAD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments.
Interventions
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).
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.
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 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwell Health
Great Neck, New York, 11021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Recruitment limitations yielded a small sample. Although outcome data are reported they should be interpreted in the context of the small sample size. We also conducted a qualitative analysis (n=24) of participants' engagement in and acceptability of alcohol treatment in a patient centered medical home.
Results Point of Contact
- Title
- Dr. Jonathan Morgenstern
- Organization
- Northwell Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
August 31, 2016
Study Start
January 1, 2017
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
October 30, 2023
Results First Posted
October 30, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share