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Partial Opioid Agonist

Injectable Buprenorphine vs Naltrexone for Opioid Use Disorder

Phase 2
Recruiting
Led By James Loughead, Ph.D.
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 2 (years 3-6)
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate how treatments for opioid use disorder affect brain activity. It will use up to three monthly injections of buprenorphine and naltrexone and measure brain activity with MRI scans.

Who is the study for?
This trial is for adults aged 18-65 with opioid use disorder, confirmed by medical assessment and tests. Participants must speak English, have a stable address and phone access. It's not for those with psychotic disorders, active liver disease, conditions affecting treatment safety or MRI contraindications. Women of childbearing age must use effective contraception.
What is being tested?
The study compares monthly injections of two drugs: Buprenorphine (Brixadi®) and Naltrexone (Vivitrol®), to understand their effects on the brain in people with opioid addiction. Brain activity will be monitored through MRIs before and after treatments over three months.
What are the potential side effects?
Possible side effects include injection site reactions, nausea, headache, dizziness from Buprenorphine; Naltrexone may cause similar reactions plus muscle cramps and insomnia. Both can affect liver enzymes so monitoring is necessary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~phase 2 (years 3-6)
This trial's timeline: 3 weeks for screening, Varies for treatment, and phase 2 (years 3-6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Urine Toxicology
Secondary study objectives
Therapeutic procedure
Clinician-reported Opioid Withdrawal
Opioid Craving
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BuprenorphineExperimental Treatment1 Intervention
Study participants receive three once-a-month injections of buprenorphine and complete weekly monitoring visits.
Group II: NaltrexoneActive Control1 Intervention
Study participants receive three once-a-month injections of naltrexone and complete weekly monitoring visits.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,084 Previous Clinical Trials
42,726,988 Total Patients Enrolled
James Loughead, Ph.D.Principal InvestigatorUniversity of Pennsylvania, Psychiatry
2 Previous Clinical Trials
468 Total Patients Enrolled

Media Library

Buprenorphine (Partial Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05596955 — Phase 2
Opioid Use Disorder Research Study Groups: Buprenorphine, Naltrexone
Opioid Use Disorder Clinical Trial 2023: Buprenorphine Highlights & Side Effects. Trial Name: NCT05596955 — Phase 2
Buprenorphine (Partial Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05596955 — Phase 2
~39 spots leftby Jul 2028
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