SuspendedPhase 4ACTRN12623000691640

Impact of injection site on buprenorphine pharmacokinetics.

The impact of injection site on the pharmacokinetics of depot buprenorphine in people with opioid use disorder: An Open-label non-randomized cross-over trial .

Sponsor

Sydney Local Health District

Enrollment

50 participants

Start Date

Dec 18, 2023

Study Type

Interventional

Conditions

Opioid Dependence

Summary

Sublocade (buprenorphine) is currently approved only for intra-abdominal subcutaneous injection for the treatment of opioid treatment disorder. However, intra-abdominal subcutaneous injection is sometimes poorly tolerated by patients because of certain discomfort. Using the same product in different sites may actually have a similar rate and extent of buprenorphine release. However, the rate and release profile of alternative injection sites (e.g., deltoid (shoulder) or thigh or buttock) compared to abdominal (stomach) injection is unknown. This study aims to evaluate the rate and extent of buprenorphine release and its tolerability from different injection sites in 50 patients who are on treatment for opioid use disorder. Eligible participants will be randomized to receive first injection sites and baseline samples will collected. Subsequent doses will be given in order abdomen, thigh, buttock, and deltoid. Serial blood samples will be collected after the injection for each subsequent injection.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria7

Aged greater than or equal to 18 years old.
Demonstrating sufficient English language ability and willing to provide written informed consent.
Willing and able to comply with requirements of the study.
Meets the criteria for opioid dependence as defined by Diagnostic and Statistical Manual of Mental Disorders – 5th Edition (DSM-5) for moderate to severe opioid use disorder.
Appropriate candidate for medically assisted treatment with partial/full opioid agonist treatment as determined by the Principal Investigator.
Stable on Sublocade treatment (i.e., 3rd dose for those on 100 mg/month maintenance or 4th dose for those on 300 mg/month maintenance or those stable on Buvidal after the 3rd dose).
Female patients of childbearing potential must be willing to use a highly effective method of contraception during the entire trial.

Exclusion Criteria11

Contraindications for partial/full opioid agonist treatment according to National Guidelines for Medication-Assisted Treatment of Opioid Dependence, 2014.
Current, severe medical condition (e.g., hepatic failure or respiratory insufficiency) assessed by Principal Investigator.
Any known hypersensitivity to buprenorphine or any component of the ATRIGEL® delivery system.
Participants with a serious untreated psychiatric comorbidity at the discretion of the Principal Investigator.
Recent history of suicidal ideation or active suicidal behaviour as based on clinical assessment.
Clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the patient from safely participating in trial.
History of Torsades de Pointes or other heart arrhythmia or an electrocardiogram (ECG) demonstrating a clinically significant abnormality, as judged by the Investigator.
Participant requiring chronic use of agents that are strong inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4) such as some azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., clarithromycin), or protease inhibitors (e.g., ritonavir, indinavir, and saquinavir).
Currently breastfeeding or pregnant.
Patients who have had an investigational new drug or device within the last 30 days.
Patients who have already participated in this study.

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Interventions

Participants currently on Buvidal (Buprenorphine Extended-Release) or Sublocade (Buprenorphine Extended-Release) will be administered their current prescribed monthly buprenorphine dose via sub-cutaneous Sublocade (Buprenorphine Extended-Release) injection. Sublocade is currently approved for abdominal sub-cutaneous injection, and participants will also receive sub-cutaneous injections in the thigh, buttock and deltoid as per the study protocol. Participants will be randomized initially to one of the 3 alternative sites (Thigh, buttock or deltoid) for their first trial dose, and subsequent doses will be given in the order of abdomen, thigh, buttock and deltoid, dependent on the initial injection site. Sublocade can only be administered by a trained nurse or medical staff member. An initial dose of 300mg Sublocade will be given at the first dose, and thereafter, 100mg or 300mg doses will be administered as decided by the site investigator in consultation with the patient. Participants will be encouraged to complete 3 doses for each injection site for a total of 12 Sublocade doses during the study period. Sublocade is administered in monthly injections, therefore overall maximum duration of study participation will be 12 months. Participant adherence and retention in treatment will be monitored through REDCap database and within secure patient logs in each site folder.