Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
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ClinicalTrials.gov Identifier: NCT02885311 |
Recruitment Status :
Active, not recruiting
First Posted : August 31, 2016
Last Update Posted : November 19, 2019
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Condition or disease | Intervention/treatment | Phase |
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Alcohol-Related Disorders Alcohol Drinking Alcoholism Alcohol Abuse Alcohol Use Disorders | Behavioral: Motivation Enhancement Therapy Behavioral: Modified Behavioral Self-Control Therapy Drug: Naltrexone Behavioral: Brief Advice Other: Referral to specialty substance use disorder treatment | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 85 participants |
Allocation: | Non-Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home |
Actual Study Start Date : | January 2017 |
Estimated Primary Completion Date : | March 2020 |
Estimated Study Completion Date : | March 2020 |

Arm | Intervention/treatment |
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At-Risk Drinkers (AR)
AR will receive feedback about their drinking and brief advice along with follow up assessments.
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Behavioral: Brief Advice
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.
Other Name: BA |
Problem Drinkers (PD)
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.
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Behavioral: Motivation Enhancement Therapy
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).
Other Name: MET Drug: Naltrexone 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).
Other Name: NTX Behavioral: Brief Advice 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.
Other Name: BA |
AD with physiological withdrawal (AD-W)
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.
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Behavioral: Modified Behavioral Self-Control Therapy
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.
Other Name: MBSCT Drug: Naltrexone 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).
Other Name: NTX Behavioral: Brief Advice 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.
Other Name: BA |
AD with complex presentation (AD-CMPLX)
AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments.
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Behavioral: Brief Advice
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.
Other Name: BA Other: Referral to specialty substance use disorder treatment 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.
Other Name: Referral |
- Change in drinking from Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]Change in drinking, as measured by the Timeline Follow Back (TLFB; a retrospective, self-report measure of drinking) will be assessed from baseline to end of treatment at week 12 in the study.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885311
United States, New York | |
Northwell Health | |
Great Neck, New York, United States, 11021 |
Responsible Party: | Jonathan Morgenstern, Director, Addiction Services, Northwell Health |
ClinicalTrials.gov Identifier: | NCT02885311 History of Changes |
Other Study ID Numbers: |
15-0743 R34AA024589 ( U.S. NIH Grant/Contract ) |
First Posted: | August 31, 2016 Key Record Dates |
Last Update Posted: | November 19, 2019 |
Last Verified: | November 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Drinking Excessive drinking Alcohol use disorders Primary Care |
Disease Alcoholism Alcohol-Related Disorders Alcohol Drinking Pathologic Processes Drinking Behavior Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Ethanol |
Naltrexone Anti-Infective Agents, Local Anti-Infective Agents Central Nervous System Depressants Physiological Effects of Drugs Alcohol Deterrents Narcotic Antagonists Sensory System Agents Peripheral Nervous System Agents |