The Depot Evaluation Buprenorphine Utilization Trial (DEBUT)

Phase 3

Completed

• Conditions: Opioid dependent; Mental Health - Addiction

• Registration Number: ACTRN12618001759280
• Lead Sponsor: Camurus AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-25
• Study Completion: 2019-09-27
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Adult male or female patient (18 years or older)
Meet the criteria for opioid dependence as defined by either the criteria for moderate to severe opioid use disorder in the Diagnostic and Statistical Manual of Mental Disorders – 5th Edition (DSM-5) OR opioid dependence in the International Statistical Classification of Diseases and Related Health Problems – 10th Edition (ICD-10) according to local practice.
Appropriate candidate for MAT with a partial opioid agonist as determined by the Investigator and is willing to continue in BPN treatment for the duration of the trial.

Exclusion Criteria

Requires 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).

Hypersensitivity or intolerance to BPN or NX or any related drug.

Having a contraindicated serious medical condition including unstable and severe pain in the opinion of the investigator.

Clinically significant laboratory and ECG abnormalities.

Recent history of significant suicidal ideation or active suicidal behavior, in the opinion of the Investigator.

Participants with serious untreated psychiatric comorbidity at the discretion of the Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective: To compare patient satisfaction with CAM2038 to buprenorphine (BPN) standard of care in adult outpatients with opioid dependence.<br>Endpoint: Treatment Satisfaction Questionnaire for Medication (TSQM) global satisfaction score.[ TSQM performed at Baseline (Day 1), Week 4, Week 12, Week 24, and Premature Discontinuation.]