Engagement Strategies for Alcoholism Treatment
(ENHANCE Trial)
Recruiting in Palo Alto (17 mi)
Overseen byE. Jennifer Edelman, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must be taking: MAUD
Disqualifiers: Opioid use disorder, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is a 3-arm randomized clinical trial to evaluate the effectiveness of hospital-initiated Alcohol Use Disorder treatment, involving a Brief Negotiated Interview (with referral and telephone booster) alone, BNI+facilitated provision of MAUD, BNI+facilitated provision of MAUD+CBT4CBT on AUD treatment engagement, alcohol use and healthcare utilization.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment BNI+facilitated provision of MAUD, Naltrexone, Acamprosate, Disulfiram, Vivitrol, Campral, Antabuse, BNI+facilitated provision of MAUD+CBT4CBT, ReVia, Vivitrol, Naltrexone Hydrochloride, Brief Negotiated Interview (BNI), Brief Negotiated Interview, BNI for alcoholism?
Research shows that naltrexone and acamprosate can help reduce alcohol consumption, and disulfiram (Antabuse) can support abstinence by causing unpleasant effects when alcohol is consumed. Behavioral therapies like the Brief Negotiated Interview (BNI) and cognitive-behavioral therapy (CBT) can enhance treatment adherence and effectiveness.
12345Is the treatment for alcoholism using medications like Naltrexone, Acamprosate, and Disulfiram generally safe for humans?
Naltrexone, Acamprosate, and Disulfiram are FDA-approved medications for treating alcohol dependence, indicating they have been evaluated for safety in humans. These medications are considered part of high-quality care for alcohol use disorder, suggesting they are generally safe when used as directed.
36789How is the treatment BNI+facilitated provision of MAUD+CBT4CBT different from other treatments for alcoholism?
This treatment is unique because it combines medication-assisted treatment (using drugs like naltrexone, acamprosate, and disulfiram) with a Brief Negotiated Interview (BNI) and cognitive-behavioral therapy (CBT4CBT), which is a digital form of therapy. This approach not only targets the brain's reward system with medication but also provides structured counseling and digital therapy to support behavior change, making it a comprehensive strategy for treating alcoholism.
367910Eligibility Criteria
This trial is for adults at Yale New Haven Hospital who've had a heavy drinking day in the past month, can consent to follow-ups, and have moderate to severe Alcohol Use Disorder. It's not for those recently in AUD treatment, pregnant/nursing women, or with life-threatening conditions that hinder participation.Inclusion Criteria
I am open to considering medical aid in dying.
Provide written informed consent
Willing and able to be contacted for follow-up
+3 more
Exclusion Criteria
Anticipate being unable to return for follow-up assessments for any reason, such as travel, incarceration, planned procedure
Meet DSM-5 criteria for untreated moderate to severe opioid use disorder
I do not have any severe health or mental conditions that prevent me from joining the study.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive hospital-initiated Alcohol Use Disorder treatment, involving a Brief Negotiated Interview (BNI) with referral and telephone booster, with or without facilitated provision of MAUD and CBT4CBT
34 days
In-hospital initiation with follow-up telephone booster
Follow-up
Participants are monitored for AUD treatment engagement, alcohol use, and healthcare utilization at 34 and 90 days post-discharge
90 days
Assessments at 34 and 90 days post-discharge
Participant Groups
The study tests three treatments post-hospitalization: Brief Negotiated Interview (BNI), BNI plus Medication-Assisted Treatment (MAUD), and BNI+MAUD combined with computer-based Cognitive Behavioral Therapy (CBT4CBT) to see which helps more with alcohol use reduction.
3Treatment groups
Experimental Treatment
Active Control
Group I: Brief Negotiated Interview (with referral and telephone booster) aloneExperimental Treatment1 Intervention
All participants will receive BNI with referral and a 15-20 minute telephone booster delivered by a trained Health Promotion Advocate (HPA) at 2 weeks. The purpose of the BNI is to assist patients in recognizing and changing levels of alcohol consumption that pose health risks. The main goals of the BNI are to: 1) lessen ambivalence about reducing alcohol use; and 2) negotiate strategies for change. During BNI, the HPA will: 1) Raise the subject of alcohol; 2) Provide feedback: review the patient's alcohol consumption, make a connection to the patient's medical condition and reason for hospitalization; review guidelines for lower risk alcohol use; 3) Enhance motivation: have the patient identify on a readiness change ruler and develop discrepancy; and 4) Negotiate and Advise: negotiate goal, give advice, have patient complete drinking agreement; summarize and arrange follow-up.
Group II: BNI+MAUD+CBT4CBTExperimental Treatment1 Intervention
Participants randomized to BNI+facilitated provision of MAUD+CBT4CBT will be given a username and password to access the web-based program and be encouraged to begin accessing the program during their hospitalization. The HPA will assist each participant with login during the first session and be available to answer any questions. Participants will be asked to complete no more than two modules per week, with an expectation of completing all seven modules by the end of the 34-day post-discharge. The program tracks, for each participant, time logged onto the program, modules accessed, progress through the program from session to session, completion of homework assignments, and learning of CBT principles through brief quizzes. Participants will be allowed to repeat modules as desired. During the BNI telephone booster, the HPA will inquire about engagement with CBT4CBT, address any questions and problems with the program, and encourage practice of coping activities (i.e., homework).
Group III: BNI+MAUDActive Control1 Intervention
For either BNI+facilitated provision of MAUD or BNI+facilitated provision of MAUD+CBT4CBT, the HPA will provide education and counseling regarding MAUD as part of the BNI to the participant and communicate to the primary medical team that MAUD is indicated. The specific MAUD chosen will be made at the discretion of the patient and the primary medical team with recommendations from the study physicians, with a goal of prioritizing FDA approved medications. Participants will be encouraged to initiate (or receive as in the case of injectable naltrexone) MAUD prior to discharge and will be provided a prescription for a 30-day supply. Medications will be obtained through regular means and not provided directly through the study. During the BNI telephone booster, the HPA will inquire about and address any barriers to MAUD and encourage continued adherence.
BNI+facilitated provision of MAUD is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as MAUD for:
- Alcohol Use Disorder
🇪🇺 Approved in European Union as MAUD for:
- Alcohol Dependence
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale New Haven HospitalNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Collaborator
References
Predictors of retention in naltrexone maintenance for opioid dependence: analysis of a stage I trial. [2016]Behavioral naltrexone therapy (BNT) was developed to address the shortcomings of naltrexone maintenance for opiate dependence and improve compliance by integrating several empirically validated methods, including the use of a significant other to monitor compliance, voucher incentives, and motivational techniques. An uncontrolled Stage I pilot trial (N = 47) of BNT was conducted. Baseline demographic and clinical variables were evaluated as predictors of retention with univariate tests. Significant predictors were entered together into a multiple regression model. Poorer (shorter) retention in treatment was associated with methadone use and higher average bags per day of heroin. Other variables that became non-significant in multiple regression analysis included older age and depressive symptoms. Individuals with greater physiologic dependence and/or dependence on longer-acting opiates are at higher risk to drop out from naltrexone maintenance and may require a more gradual detoxification and more intensive behavioral therapy aimed at enhancing initial compliance.
Behavioral naltrexone therapy: an integrated treatment for opiate dependence. [2019]Treatment of opiate dependence with naltrexone has been limited by poor compliance. Behavioral Naltrexone Therapy (BNT) was developed to promote adherence to naltrexone and lifestyle changes supportive of abstinence, by incorporating components from empirically validated treatments, including Network Therapy with a significant other to monitor medication compliance, the Community Reinforcement Approach, and voucher incentives. An overview is presented of the BNT treatment manual. In an uncontrolled Stage I trial (N = 47), 19% completed the 6-month course of treatment. Retention was especially poor in the subsample of patients who were using methadone at baseline (N = 18; 39% completed 1 month, none completed 6 months), and more encouraging among heroin-dependent patients (N = 29; 65% completed 1 month, 31% completed 6 months). Thus, attrition continues to be a serious problem for naltrexone maintenance, although further efforts to develop interventions such as BNT are warranted.
A longitudinal examination of alcohol pharmacotherapy adoption in substance use disorder treatment programs: patterns of sustainability and discontinuation. [2022]The objectives of this study were to (a) identify the patterns of disulfiram (Antabuse) and tablet naltrexone (Revia) adoption over a 48-month period in a nationally representative sample of privately funded programs that deliver substance use disorder treatment; (b) examine predictors of sustainability, later adoption, discontinuation, and nonadoption of disulfiram and tablet naltrexone; and (c) measure reasons for medication discontinuation.
Baseline trajectories of drinking moderate acamprosate and naltrexone effects in the COMBINE study. [2021]The COMBINE study evaluated the effects of acamprosate, naltrexone, and the Combined Behavioral Intervention (CBI). In secondary analyses, our goals were to identify trajectories of any drinking prior to randomization, to characterize subjects in these trajectories, and to assess whether prerandomization trajectories predict drinking outcomes and moderate treatment response.
A randomized, multicentre, open-label, comparative trial of disulfiram, naltrexone and acamprosate in the treatment of alcohol dependence. [2018]To compare the effects in alcohol-dependent patients of three pharmacotherapies, disulfiram (DIS), naltrexone (NTX), and acamprosate (ACA), when used with a brief manual-based cognitive-behavioural intervention.
Choosing the right medication for the treatment of alcoholism. [2022]In the past decade, scientists have made important progress toward understanding the neurobiology underlying an alcohol disorder. This knowledge has led to the development of promising pharmacotherapies that target the neural pathways involved in the brain's reward center in such a way that the usual treatment response (via counseling) is substantially improved upon. There are now four US Food and Drug Administration (FDA)-approved pharmacotherapies for the treatment of alcohol dependence: disulfiram (Antabuse; Odyssey Pharmaceuticals, East Hanover, NJ), oral naltrexone (ReVia; Barr Pharmaceuticals, Inc., Pomona, NY), acamprosate (Campral; Forest Laboratories, Inc., New York, NY), and, as of April 2006, an extended-release (30-day) injectable suspension formulation of naltrexone (Vivitrol; Alkermes, Inc., Cambridge, MA). Other types of medications (eg, topiramate and quetiapine) are currently under investigation for the treatment of alcohol dependence. Research also has provided insights into best practices for prescribing the available medications. This report reviews the latest innovations in pharmacotherapy for the treatment of alcohol dependence, focusing on FDA-approved medications presently available to the treatment community.
Relationship Between Primary Care Providers' Perceptions of Alcohol Use Disorder And Pharmacotherapy Prescribing Rates. [2023]Acamprosate, naltrexone and disulfiram are underprescribed for alcohol use disorder (AUD) with marked variability among primary care providers (PCPs). We aimed to identify differences between high and low prescribers of medications for AUD (MAUD) with regard to knowledge, experiences, prioritization and attitudes.
Receipt of pharmacotherapy for alcohol use disorder by justice-involved women in the Veterans Health Administration. [2021]Alcohol use disorder (AUD) and unhealthy drinking are prevalent among women involved in the criminal justice system and women military veterans. Pharmacotherapy-including naltrexone, topiramate, acamprosate, and disulfiram-for AUD is one form of effective treatment that is associated with better health and criminal justice outcomes. The current study examined the association of justice involvement with receipt of pharmacotherapy for AUD, as well as other patient factors that may explain variation in receipt of pharmacotherapy for AUD among women veterans who receive care at Veterans Health Administration (VHA) facilities.
Pharmacotherapy of alcohol use disorders in the Veterans Health Administration. [2022]Acamprosate, oral and long-acting injectable naltrexone, and disulfiram are approved for treatment of alcohol dependence. Their availability and consideration of their use in treatment are now standards of high-quality care. This study determined rates of medication initiation among Veterans Health Administration (VHA) patients.
Spouse contracting to increase antabuse compliance in alcoholic veterans. [2019]Developed and evaluated a home-based contracting program to determine its effect on the compliance rates of discharged alcohol patients to a disulfiram (antabuse) regimen. The three comparison groups included (a) no contract/no recording; (b) contract/recording; and (c) contract/recording plus instructions for positive reinforcement. Twenty-five patients who had been treated in a behaviorally oriented inpatient alcohol dependence treatment program and who lived with a significant other (i.e., spouse, sibling, parent) participated in the study. At the end of the 3-month period for which the disulfiram was prescribed, those Ss who were involved in contracting and recording reached criterion more frequently than those who were in the minimal treatment group. Furthermore, 84% of this S sample were abstinent at the 3-month follow-up according to collateral reports. The discussion centers on the use of home-based contracting as an inexpensive alternative to other, more costly disulfiram programs. Additional methods for obtaining measures of reliability on self-report of disulfiram usage also are discussed.