Impact of injection site on buprenorphine pharmacokinetics.

Phase 4

Suspended

• Conditions: Opioid Dependence; Mental Health - Addiction

• Registration Number: ACTRN12623000691640
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-28
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Aged greater than or equal to 18 years old.
2.Demonstrating sufficient English language ability and willing to provide written informed consent.
3.Willing and able to comply with requirements of the study.
4.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.
5.Appropriate candidate for medically assisted treatment with partial/full opioid agonist treatment as determined by the Principal Investigator.
6.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).
7.Female patients of childbearing potential must be willing to use a highly effective method of contraception during the entire trial.

Exclusion Criteria

1.Contraindications for partial/full opioid agonist treatment according to National Guidelines for Medication-Assisted Treatment of Opioid Dependence, 2014.
2.Current, severe medical condition (e.g., hepatic failure or respiratory insufficiency) assessed by Principal Investigator.
3.Any known hypersensitivity to buprenorphine or any component of the ATRIGEL® delivery system.
4.Participants with a serious untreated psychiatric comorbidity at the discretion of the Principal Investigator.
5.Recent history of suicidal ideation or active suicidal behaviour as based on clinical assessment.
6.Clinically significant laboratory abnormalities, which in the opinion of the Investigator may prevent the patient from safely participating in trial.
7.History of Torsades de Pointes or other heart arrhythmia or an electrocardiogram (ECG) demonstrating a clinically significant abnormality, as judged by the Investigator.
8.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).
9.Currently breastfeeding or pregnant.
10.Patients who have had an investigational new drug or device within the last 30 days.
11.Patients who have already participated in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified