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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
18-65 Years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase 2 (years 3-6)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Limbic System
Urine Toxicology
Secondary outcome measures
Therapeutic procedure
Clinician-reported Opioid Withdrawal
Opioid Craving
+2 more

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
1,994 Previous Clinical Trials
42,879,196 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA given its stamp of approval to Buprenorphine?

"Our team assigned buprenorphine a score of 2, as we have some confidence in its safety from Phase 2 trials but no evidence yet on the drug's efficacy."

Answered by AI

What goals does this investigation seek to achieve?

"During this Phase 2 (Years 3-6) study, researchers will evaluate the Fronto-limbic brain fMRI response to XRNTX and XRBUP. Secondary metrics include medication adherence, opioid craving as measured by a standard clinical questionnaire (OCS), and self-reported opioid withdrawal assessed using a Likert scale on the Subjective Opioid Withdrawal Scale (SOWS)."

Answered by AI

For which demographic is this study most suitable?

"This medical study seeks 60 participants, aged 18-65, who have been medically diagnosed with opioid use disorder (OUD). Candidates must also demonstrate that opioids are their primary drug of choice; be interested in extended release agonist or antagonist treatment; possess a stable address and working command of the English language; as well as access to telephone services."

Answered by AI

Are participants aged 80 or above eligible for inclusion in this investigation?

"Eligibility for this study is limited to those between legal adulthood and seniority, i.e., individuals aged 18-65."

Answered by AI

Are researchers currently enrolling participants in this experiment?

"As found on clinicaltrials.gov, this particular medical experiment is not accepting new participants at present. It was initially made public on November 1st 2022 and lastly updated October 24th 2022. Despite the fact that it isn't recruiting patients right now, there are 533 other trials available which are presently seeking volunteers."

Answered by AI
~40 spots leftby Jul 2028