Trial Outcomes & Findings for Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home (NCT NCT02885311)

AR will receive feedback about their drinking and brief advice along with follow up assessments. 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.

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. 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). 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.

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. 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. 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. 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.

AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments. 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. 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.

n=6 Participants

AR will receive feedback about their drinking and brief advice along with follow up assessments. 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.

n=10 Participants

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. 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). 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.

n=9 Participants

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. 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. 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. 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.

n=2 Participants

AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments. 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. 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.

n=27 Participants

Total of all reporting groups

n=6 Participants

AR will receive feedback about their drinking and brief advice along with follow up assessments. 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.

n=8 Participants

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. 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). Naltrexone: Participants, who choose medication treatment, will be offered naltrexone (50 mg per day), which is an FDA-Approved medication for alcohol use disorder. 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.

n=9 Participants

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. 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. Naltrexone: Participants, who choose medication treatment, will be offered naltrexone (50 mg per day), which is an FDA-Approved medication for alcohol use disorder. 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.

n=2 Participants

AD-CMPLX will receive a referral to specialty substance use disorder treatment and also receive follow up assessments. 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. 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.