Efficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effectiveness of a new pharmacological approach to increase efficacy of treatment with extended release naltrexone (XR-naltrexone) for individuals with opioid use disorder by combining it with buprenorphine-naloxone. This is a two arm, double-blind, placebo-controlled study to examine whether addition of buprenorphine-naloxone will improve treatment retention, reduce opioid craving, and improve mood over 24 weeks of treatment with extended release naltrexone (XR-naltrexone) administered every four weeks for a total of 6 injections.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

• Individuals between the ages of 18-65 (inclusive) interested in antagonist-based relapse prevention treatment

• Meets current DSM-5 criteria for current opioid use disorder of at least six months duration supported by urine toxicology positive for opioids OR naloxone challenge if seeking detoxification and XR-NTX induction OR confirmed recent detoxification treatment for opioids.

• In otherwise good health based on complete medical history, physical examination, vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry, urinalysis) within normal ranges.

• Participants with active opioid use and those who recently completed detoxification and received XR-NTX are eligible for the study. Participants may be enrolled before initial XR-NTX injection or up to 2 weeks following an initial XR-NTX injection given in any outside research or community-based treatment setting (inpatient, outpatient residential). However, participants who had 30 or more opioid-free days prior to consent will not be eligible for study inclusion.

• Voluntarily seeking treatment for opioid use disorder.

• Able to give written informed consent to participate in the study and showing a thorough understanding of the difference between agonist and antagonist-based treatment.

Exclusion Criteria:

• Methadone maintenance or any use of illicit methadone in the week prior to XR-NTX induction.

• Maintenance on buprenorphine or frequent buprenorphine use in the week prior to XR-NTX induction (must be using no more than 8 mg of buprenorphine per day and no more than 3 days per week).

• Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with AST/ALT> 3 times normal, AIDS (CD4 count under 200 or medically ill), unstable diabetes or unstable heart disease.

• Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-5 Schizophrenia or any psychotic disorder, severe Major Depressive Disorder, chronic Neurocognitive Disorder, or suicide risk or 1 or more suicide attempts within the past year

• Pregnancy, lactation, or a plan of becoming pregnant. Women need to have negative blood pregnancy test at screening and agree to practice dual contraceptives.

• Physiological dependence on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary.

• History of allergic or adverse reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.

• History of accidental drug overdose in the prior 6 months defined as an episode of opioid-induced unconsciousness, whether or not medical treatment was sought or received.

• Painful medical condition that requires ongoing opioid analgesia or anticipated surgery necessitating opioid medications.