In Hospital IM Naltrexone: A Pilot Study

NCT05087771 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 21-4489
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study in-hospital administration of injectable naltrexone vs. oral naltrexone. This is a pilot study to assess provider's and patient's acceptability to be randomized to oral vs. injectable naltrexone among hospitalized adults with alcohol use disorder.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Recruitment rate

  The investigators will assess recruitment rate for IM naltrexone and oral naltrexone o Recruitment is defined as (\[number of participants enrolled / number of participants enrolled approached\] / 12 months)

  12 months

Secondary Outcomes (3)

• II. Acceptability and Feasibility Measures

  prior to study implementation and after 50% enrollment is completed, approximately 6 months from study start date

• III. Comparative Effectiveness: Combined all-cause 30-day readmission rate + all cause 30-day emergency department encounter rate.

  30 days from time of last person enrolled in study

• IV. Comparative Effectiveness: 90-day addiction treatment encounter rate for participants randomized to IM vs. oral naltrexone

  90 days from time of last person enrolled in study

Study Arms (2)

Oral naltrexone

ACTIVE COMPARATOR

patients will receive a 30 day supply of oral naltrexone 50 mg daily at hospital discharge. This medication was FDA approved in 1984 for the treatment of alcohol use disorder

Drug: oral naltrexone

injectable naltrexone

EXPERIMENTAL

patient will receive 360 mg injection of naltrexone prior to hospital discharge

Drug: injectable naltrexone

Interventions

injectable naltrexone DRUG

360 mg dose to be given prior to hospital discharge

Also known as: Vivitrol

injectable naltrexone

oral naltrexone DRUG

50 mg tab dispense 30 day supply to be given at hospital discharge

Oral naltrexone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will include hospitalized adults, aged 18 to 65 years old, who receive care from the ACS during their hospitalization and who meet DSM - 5 criteria for alcohol use disorder.

You may not qualify if:

• Naltrexone is contraindicated in acute hepatitis or liver failure and its use in patients with active liver disease must be carefully considered in light of the potential for hepatotoxic effects.23 It is also contraindicated in patients taking opioids for pain due to its antagonism at the opioid receptor.23 The investigators will exclude people who meet the following criteria:
• Liver function test (AST/ALT) more than five times the upper limit of normal
• Decompensated liver failure defined as use of lactulose for prevention of hepatic encephalopathy, ascites, use of spironolactone and/or lasix for ascites, presence of hepatic encephalopathy, International Normalized Ratio (INR) \>2, or thrombocytopenia in the setting of known liver disease
• Renal failure, defined as a glomerular filtration rate of \<30 ml/min
• On opioids for acute or chronic pain at time of study enrollment
• Pregnancy, IM naltrexone is not FDA approved in pregnancy

Sponsors & Collaborators

• University of Colorado, Denver: lead

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MeSH Terms

Conditions

Alcoholism

Interventions

vivitrol; Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Susan Lynn Calcaterra, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: one group randomized to oral naltrexone; one group randomized to injectable naltrexone

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 21, 2021
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: June 1, 2023
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share