Alcohol Disorder hOsPital Treatment Trial
ADOPT
Oral v. Injection Naltrexone in Hospital: Comparative Effectiveness for Alcoholism
2 other identifiers
interventional
248
1 country
1
Brief Summary
The specific aims of this pragmatic randomized controlled trial are to compare initiating injectable extended release naltrexone (XR-NTX) or oral naltrexone (PO-NTX) at the time of discharge from a medical hospitalization for patients with alcohol use disorder (AUD) on: 1) alcohol consumption and consequences, and 2) acute healthcare utilization (including hospital readmission and emergency visits) and cost-effectiveness. In exploratory analyses, the investigators will assess moderators of medication effects including demographic, behavioral, and genetic factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2016
Longer than P75 for phase_4
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
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedResults Posted
Study results publicly available
June 29, 2021
CompletedJune 29, 2021
June 1, 2021
4.1 years
June 11, 2015
June 9, 2021
June 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back
The primary alcohol use outcome will be change in percent heavy drinking days (%HDDs) from baseline to 3 month follow-up. %HDDs out of the past 30 days is assessed using the Timeline Follow-Back. %HDDs is the most likely (and most sensitive) to be affected by NTX and is clinically important (any reduction means less risk of harm). We chose self-report because biological testing is not sufficiently valid for detecting drinking levels and changes of clinical importance. The self-report tool is valid, particularly so when staff are well trained, and when the context for the subject is: they are informed they are being tested for consumption (breath alcohol and carbohydrate deficient transferrin (CDT), there are no consequences related to consumption levels, and that results are being recorded confidentially.
Baseline, 3 months
Secondary Outcomes (1)
Acute Care Hospital Utilization
3 months
Other Outcomes (4)
Medication Adherence
1, 2 and 3 months
Alcohol Consequences Via Questionnaire
3 months
Alcohol Use Disorder-related Treatment Utilization Via Questionnaire and Health Records
3 months
- +1 more other outcomes
Study Arms (2)
Extended-release injectable naltrexone (XR-NTX)
EXPERIMENTALMonthly XR-NTX (380 mg) Subjects randomized to XR-NTX will receive one intramuscular gluteal injection (in accordance with the FDA approved label/package insert) of 380 mg of NTX for extended-release injectable suspension at study entry (in the hospital) and 1, and 2 months later (outpatient in the primary care clinic), alternating buttocks.
Oral naltrexone (PO-NTX)
ACTIVE COMPARATORDaily PO-NTX (50 mg, up to 100 mg if heavy drinking continues) Subjects randomized to PO-NTX will receive a study prescription (first one in the hospital)(fillable only at the medical center research pharmacy and prepared by the research pharmacist) for a 1-month supply of oral NTX to be taken once daily- 25 mg a day for 3 days, then 50 mg a day. If the subject has a prior history of taking PO-NTX and tolerating it well, the participant may be started at 50 mg. The dose may be increased to 100 mg daily for any participant who continues to have heavy drinking.
Interventions
injectable naltrexone
Eligibility Criteria
You may qualify if:
- Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 alcohol use disorder (AUD) (assessed using Alcohol Use Disorder and Associated Disabilities Interview Schedule (AUDADIS))
- ≥1 heavy drinking episodes (≥5 standard drinks \[4 for women\] in a day) in 30 days prior to hospitalization\*
- Inpatient on a hospital general medical service
- Adult (age 18 years or greater)
- Ability to speak English (fluency)
- ≥2 contact persons\*
You may not qualify if:
- Pregnancy (urine testing if childbearing potential)
- Currently breast-feeding
- Urine expanded panel drug test (dipstick) positive for opiates, semi-synthetic or synthetic opioids
- Opioid use (self-report and verification in medical record) in past 7 days for long-acting opioids
- Opioid use in past 24 hours for short-acting opioids
- Discharge prescription for opioids
- Future need for opioids for an anticipated painful event or surgery
- Known hypersensitivity to NTX
- Acute severe psychiatric illness (currently suicidal or psychotic)
- Cognitive dysfunction that precludes informed consent or research assistant (RA) assessment that subject cannot understand interview questions
- Alanine aminotransferase or aspartate aminotransferase \>5 times the upper limit of normal
- Acute hepatitis
- Liver failure
- Known severe thrombocytopenia (\<50,000)
- Coagulopathy
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Related Publications (1)
Magane KM, Dukes KA, Fielman S, Palfai TP, Regan D, Cheng DM, Lee H, Kraemer KL, Bullard MJ, Chen CA, Samet JH. Oral vs Extended-Release Injectable Naltrexone for Hospitalized Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):635-645. doi: 10.1001/jamainternmed.2025.0522.
PMID: 40257810DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Richard Saitz, MD MPH
- Organization
- Boston University School of Public Health and School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Saitz, MD, MPH
Boston University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 23, 2015
Study Start
June 1, 2016
Primary Completion
July 1, 2020
Study Completion
October 1, 2020
Last Updated
June 29, 2021
Results First Posted
June 29, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- IPD will first be available to ADOPT study investigators and Boston Medical Center and Boston University affiliated trainees. After establishing the specific areas to be addressed in the papers reporting the main findings of the study, all IPD and sample repository data will be made available for sharing starting 12 months after publication of these main study findings.
- Access Criteria
- The ADOPT study PI (Saitz), with co-investigator consultation as necessary, will review and approve proposals submitted by interested and qualified researchers wishing to conduct secondary analysis of the data and use of biological samples beyond the main planned reports of study findings. If proposals are approved, the investigators will make the de-identified IPD and samples available for analysis, provided IRB approval is obtained. These investigators will be provided with study forms and documents (e.g., data dictionary, procedure manuals, study questionnaires as appropriate) that allow accurate understanding of the datasets. Costs associated with data sharing will be the responsibility of investigators seeking the data.
The ADOPT study dataset will include data from 260 subjects, including self-reported demographic and alcohol/drug use information as well as study-specific assessments and information obtained from urine and blood samples. All IPD and sample repository data will be made available to interested and qualified researchers wishing to conduct secondary analyses of the data. The final datasets will be stripped of identifiers prior to release for sharing.