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Inpatient Single Dose Interventions for Alcohol Use Disorder
EARLY_PHASE1 trial testing Naltrexone 380 MG in Alcohol Use Disorder, Severe in 44 participants. Completed in 1 February 2022.
| Lead sponsor | Denver Health and Hospital Authority |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 19 January 2021 |
| Primary completion | 1 January 2022 |
| Estimated completion | 1 February 2022 |
| Sites | 1 location across United States |
Denver Health and Hospital Authority
Adults 18 to 65, any sex, with Alcohol Use Disorder, Severe. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Binary outcome: any all-cause hospitalization ascertained by chart review (our EHR includes records from several local hospitals). Note that it is not dependent on study completion, so it is analyzed by intent to treat.
| Group | Value | 95% CI |
|---|---|---|
| XR Naltrexone | 3 | |
| IV Ketamine | 2 | |
| Linkage | 7 |
Number of participants recruited per month during the enrollment period
| Group | Value | 95% CI |
|---|---|---|
| Full Trial Sample | 3.7 | ± 2.8 |
Percentage of patients who presented to follow-up appointment within 14 days
| Group | Value | 95% CI |
|---|---|---|
| XR Naltrexone | 7 | |
| IV Ketamine | 8 | |
| Linkage | 7 |
Binary outcome: any all-cause ED visit ascertained by chart review
| Group | Value | 95% CI |
|---|---|---|
| XR Naltrexone | 8 | |
| IV Ketamine | 7 | |
| Linkage | 12 |
Time frame: Immediate effects of IM naltrexone or IV ketamine were assessed immediately after administration in the hospital. Adverse events by PRISE questionnaire were assessed at follow-up visit (targeted at 1 week post-discharge) for those who attended. Deaths and serious adverse events would be detected at any point within 30 days post-discharge from electronic health record alerts, direct patient communication with study team, or other staff communication.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | XR Naltrexone | IV Ketamine | Linkage |
|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | — | — | — |
| decreased appetite | Gastrointestinal disorders | — | — | — |
| abnormal dreams | Psychiatric disorders | — | — | — |
| anxiety | Psychiatric disorders | — | — | — |
| anxiety | Psychiatric disorders | — | — | — |
| fatigue or decreased energy | General disorders | — | — | — |
| restlessness | General disorders | — | — | — |
| increased appetite | Gastrointestinal disorders | — | — | — |
| dizziness on standing | Cardiac disorders | — | — | — |
| dry skin | Skin and subcutaneous tissue disorders | — | — | — |
| poor coordination | Nervous system disorders | — | — | — |
| dizziness or lightheadedness | Nervous system disorders | — | — | — |
| frequent urination | Renal and urinary disorders | — | — | — |
| difficulty sleeping | Psychiatric disorders | — | — | — |
| poor concentration | Psychiatric disorders | — | — | — |
| constipation | Gastrointestinal disorders | — | — | — |
| dry mouth | Gastrointestinal disorders | — | — | — |
| chest pain | Cardiac disorders | — | — | — |
| shortness of breath | Respiratory, thoracic and mediastinal disorders | — | — | — |
| cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| pain with breathing | Respiratory, thoracic and mediastinal disorders | — | — | — |
| headache | Nervous system disorders | — | — | — |
| tremor | Nervous system disorders | — | — | — |
| tremor | Nervous system disorders | — | — | — |
| numbness or tingling | Nervous system disorders | — | — | — |
| speech difficulty | Nervous system disorders | — | — | — |
| blurred vision | Eye disorders | — | — | — |
| blurred vision | Eye disorders | — | — | — |
| difficulty urinating | Renal and urinary disorders | — | — | — |
| increased libido | Reproductive system and breast disorders | — | — | — |
| memory loss | Psychiatric disorders | — | — | — |
| poor concentration | Psychiatric disorders | — | — | — |
| fatigue or decreased energy | Psychiatric disorders | — | — | — |
| restlessness | General disorders | — | — | — |
| diarrhea | Gastrointestinal disorders | — | — | — |
| diarrhea | Gastrointestinal disorders | — | — | — |
| dry mouth | Gastrointestinal disorders | — | — | — |
| nausea/vomiting | Gastrointestinal disorders | — | — | — |
| nausea/vomiting | Gastrointestinal disorders | — | — | — |
| abdominal pain | Gastrointestinal disorders | — | — | — |
Data from ClinicalTrials.gov NCT04562779 adverse events section.
Every year, alcohol use disorder (AUD) generates millions of emergency department (ED) visits and hospital admissions, costing the U.S. health sector over $90 billion. These hospital admissions are critical opportunities to start patients on addiction pharmacotherapy, but factors like medication non-adherence and post-discharge relapse contribute to frequent re-admissions. Two single-dose interventions are well suited to facilitate treatment retention and prevent re-admissions due to their prolonged, adherence-independent effects: extended-release (XR) naltrexone injection and intravenous (IV) ketamine infusion. These have not been thoroughly investigated in the hospital setting among high-utilizer, safety-net populations. Therefore, the investigators aim to: 1. Test the feasibility of randomizing hospitalized patients (n=45-60, age 18-65) with multiple AUD-related admissions to treatment with either extended-release (XR) naltrexone, intravenous (IV) ketamine, or no single-dose medication, all with enhanced linkage to care. Feasibility outcomes such as recruitment rate, patient acceptability, post-discharge follow-up rate, and adverse events will help to identify key lessons for a future comparative effectiveness study. 2. Estimate the 30-day re-admission rate for patients randomized to treatment with XR naltrexone, with IV ketamine, or no single-dose medication, all with enhanced linkage to care. The investigators hypothesize that the re-admission rate will be lower for each of the two single-dose medication groups than for the "linkage-alone" group.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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