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Opioid Partial Agonist

Extended-release Buprenorphine: Buttocks for Opioid Use Disorder

Phase 4
Waitlist Available
Research Sponsored by Indivior Inc.
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 day 1 at 1, 5, 10, 15, and 30 minutes post dosing
Awards & highlights

Study Summary

This trial looks at different injection sites for extended-release buprenorphine to treat opioid use disorder. Results help determine which sites are best for long-term use.

Eligible Conditions
  • Opioid Use Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on days 4, 6, 8, 11, 15, 18, 22, 25, and 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 at predose and at 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 hours post-dose and on days 4, 6, 8, 11, 15, 18, 22, 25, and 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-time Curve from Study Day 1 to Day 29 (AUC0-28days) of Buprenorphine
Maximum Observed Plasma Concentration (Cmax) of Buprenorphine
Secondary outcome measures
Injection Site Grading
Injection Site Pain
Number of Participants with Treatment-emergent Adverse Events Identified as Injection Site Reactions
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Extended-release Buprenorphine: Upper ArmExperimental Treatment1 Intervention
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the back of the upper arm on Day 1.
Group II: Extended-release Buprenorphine: ThighExperimental Treatment1 Intervention
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the thigh on Day 1.
Group III: Extended-release Buprenorphine: ButtocksExperimental Treatment1 Intervention
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the buttocks on Day 1.
Group IV: Extended-release Buprenorphine: AbdomenActive Control1 Intervention
Participants will receive a single, subcutaneous injection of 300 mg extended-release buprenorphine in the abdomen on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Buprenorphine Extended-Release Injection
2023
Completed Phase 4
~90

Find a Location

Who is running the clinical trial?

Indivior Inc.Lead Sponsor
53 Previous Clinical Trials
10,575 Total Patients Enrolled
Global Director Clinical DevelopmentStudy DirectorIndivior Inc.
4 Previous Clinical Trials
1,479 Total Patients Enrolled

Media Library

Buprenorphine Extended-Release Injection (Opioid Partial Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05704543 — Phase 4
Opioid Use Disorder Research Study Groups: Extended-release Buprenorphine: Buttocks, Extended-release Buprenorphine: Abdomen, Extended-release Buprenorphine: Upper Arm, Extended-release Buprenorphine: Thigh
Opioid Use Disorder Clinical Trial 2023: Buprenorphine Extended-Release Injection Highlights & Side Effects. Trial Name: NCT05704543 — Phase 4
Buprenorphine Extended-Release Injection (Opioid Partial Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05704543 — Phase 4

Frequently Asked Questions

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

Is the trial inclusive of individuals aged sixty and older?

"According to the criteria for study enrolment, participants must be between 18 and 65 years of age."

Answered by AI

To what extent is Extended-release Buprenorphine: Upper Arm treatment safe for patients?

"We have assigned Extended-release Buprenorphine's safety a score of 3, owing to it having reached Phase 4 trials and thus earned approval."

Answered by AI

Are there any vacancies still available to join this research endeavor?

"Affirmative. The information on clinicaltrials.gov highlights that this medical experiment is actively seeking volunteers, with the initial post made on March 1st 2023 and most recent update from March 3rd 2023. A total of 80 subjects are required to be recruited at 2 different sites."

Answered by AI

What is the scope of this experiment in terms of participants?

"That is accurate. According to information found on clinicaltrials.gov, this research project was first announced on March 1st 2023 and has been actively searching for 80 volunteers across 2 medical centres since then."

Answered by AI

Which individuals meet the criteria for participating in this research?

"This trial is searching for 80 individuals with a moderate to severe opioid use disorder aged between 18 and 65. To qualify, potential participants must have signed an informed consent form (ICF) demonstrating their willingness to comply with the restrictions laid out in the document; be of either gender; possess a body mass index falling between 18-33 kg/m^2.; not already be receiving treatment or medication related to OUD other than those administered by this study; and agree not to take any buprenorphine containing products throughout its duration."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
InSite Clinical Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~44 spots leftby Mar 2025