Clinical Trial Details

The Depot Evaluation Buprenorphine Utilization Trial (DEBUT)

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Trial Information

Broad Health Condition Mental Health

Specific Health ConditionAddiction

Trial FocusTreatment

Recruitment statusCompleted

Recruitment Details
Recruitment State
NSW,SA,VIC

Hospital
The Langton Centre - Surry Hills
Royal Prince Alfred Hospital - Camperdown
Drug and Alcohol Clinical Services, Hunter New England Local Health District - Newcastle
Blacktown Hospital - Blacktown
Drug & Alcohol Services South Australia (DASSA) - Stepney
Turning Point Drug and Alcohol Centre - Richmond


Postcode
2010 - Surry Hills
2050 - Camperdown
2300 - Newcastle
2148 - Blacktown
5069 - Stepney
3121 - Richmond

Phase of TrialPhase 3

Has the study received ethics approval?Further information iconApproved

Trial summary

This is a prospective, randomised, openlabel, activecontrolled, multicenter
trial comparing treatment effects of CAM2038 (BPN depot injection) with BPN standard of care (for example, sublingual [SL] BPN or BPN/naloxone [BPN/NX]) in adult outpatients with opioid dependence.
Opioid dependent patients who are either currently receiving medication assisted treatment (MAT) with SL BPN or BPN/NX, or patients who are actively seeking BPN standard of care treatment but who have not yet begun a treatment regimen, may be eligible for the trial.
Patients will be randomised in a 1:1 ratio to either CAM2038 (involving either weekly or monthly depot injections based upon prescriber and patient choice) or BPN standard of care MAT. Stratification by new to treatment will be applied.
The trial will consist of a Screening Period of up to 4 weeks duration, a Treatment Period of 24 weeks duration, and a Followup Period of 2 weeks duration.
Outcomes relevant to study include the treatments’ perspective impact on patient’s satisfaction of treatment and other patient reported outcomes (PROs), as well as understanding the potential health economic impact and resource utilization with CAM2038 treatment.
Eligibility

Key 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.

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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.
Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Camurus AB
Primary Sponsor Address: Camurus AB Ideon Science Park Sölvegatan 41 SE 223 70 Lund, Sweden
Primary Sponsor Country: Sweden

Trial IDACTRN12618001759280

UTNHS-17-585

Contact person for information and recruitmentMs
Lauren Rogers
PAREXEXL International Suite B, Level 6 15 Talavera Road North Ryde, NSW 2113 Australia
+61 2 8870 3175

Further information iconLauren.Rogers@PAREXEL.com
Australia