Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000385448
Ethics application status
Approved
Date submitted
29/03/2025
Date registered
30/04/2025
Date last updated
30/04/2025
Date data sharing statement initially provided
30/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to assess direct transfer from methadone to CAM2038 (buprenorphine) in patients with opioid dependence
Scientific title
A Phase 2, Open-Label Trial Assessing the Feasibility of Direct Transfer from Methadone to CAM2038 (Buprenorphine) in Patients with Opioid Dependence
Secondary ID [1] 312884 0
HS-24-778
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid dependence 335058 0
Condition category
Condition code
Mental Health 331567 331567 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Methadone: During the screening period, participants will take their previously prescribed methadone dose (>30 to 100 mg/day). On Day -3 (start of the run-in period), participants will be switched to IMP methadone (oral liquid) at the same daily dose level as the previously prescribed methadone. Starting on Day 4, the methadone dose will be tapered to reach a dose of less than or equal to 30 mg by Day 7 (the last methadone dose). Administration of IMP methadone on Day -3 to Day -1 and on Day 3 to Day 7 will take place at an outpatient clinic. On Day 1 and Day 2, administration of IMP methadone will take place at an inpatient trial facility.
Buprenorphine: CAM2038 will be administered as subcutaneous injections in the buttock, thigh, abdomen, and/or upper arm. CAM2038 will be administered by a designated healthcare professional. Injections will be given on Day 1 (8 mg), Day 4 (8 mg), Day 8 (16 mg), and Day 15 (16, 24 or 32 mg, depending on the total dose of CAM2038 given the previous week). Supplemental doses of 8 mg CAM2038 may be given if needed on Day 9 to Day 14 (1 dose, or 2 doses at least 1 day apart) and Day 16 to Day 21 (1 dose). Supplemental doses will be given at the Investigator’s discretion. Reasons for administration of supplemental doses of CAM2038 will be recorded. Administration of CAM2038 on Day 1 will take place at an inpatient trial facility. All other CAM2038 administrations (including supplemental doses) will take place at an outpatient clinic.
All administration of IMP methadone and CAM2038 will be supervised. Adherence to the intervention is, hence, ensured.
Intervention code [1] 329439 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339306 0
Proportion of participants receiving the third CAM2038 dose on Day 8.
Timepoint [1] 339306 0
At the conclusion of the trial
Secondary outcome [1] 439592 0
Change from baseline over time in COWS scores
Timepoint [1] 439592 0
From baseline until End of Treatment (EOT)/Day 22
Secondary outcome [2] 439596 0
Time to POW
Timepoint [2] 439596 0
Within 30 hours after the first CAM2038 dose
Secondary outcome [3] 439597 0
Occurrence of adverse events (AEs)
Timepoint [3] 439597 0
From the first dose of IMP on Day -3 to the Day 22 visit (i.e., treatment-emergent AEs)
Secondary outcome [4] 439593 0
Change from baseline over time in Objective Opiate Withdrawal Scale (OOWS) scores
Timepoint [4] 439593 0
From baseline until EOT/Day 22
Secondary outcome [5] 439415 0
Proportion of participants experiencing precipitated opioid withdrawal (POW), where POW is defined as an increase from baseline in Clinical Opiate Withdrawal Scale (COWS) scores of greater than or equal to 6 points and a total COWS score greater than or equal to 13
Timepoint [5] 439415 0
Individual participants will be assessed within 30 hours after the first CAM2038 dose. The proportion of participants experiencing POW will be assessed at the conclusion of the trial.
Secondary outcome [6] 439594 0
Change from baseline over time in Short Opioid Withdrawal Scale-Gossop (SOWS-Gossop) scores
Timepoint [6] 439594 0
From baseline until EOT/Day 22
Secondary outcome [7] 439595 0
Change from baseline over time in the 3-item craving scale scores
Timepoint [7] 439595 0
From baseline until EOT/Day 22

Eligibility
Key inclusion criteria
-Received opioid agonist therapy treatment with methadone for opioid dependence at a stable prescribed dose of >30 to 100 mg/day for at least 4 weeks before screening. The dose may vary +/-10% but the prescribed dose must not be below 31 mg/day or above 100 mg/day.
-COWS score less than or equal to 12 within 24 hours after the latest methadone dose at screening.
-Body mass index <30.0 kg/m^2.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Having moderate or severe psychological distress, i.e., a score of greater than or equal to 25 on the Kessler Psychological Distress Scale (K10) at screening.
-Use of opioids or illegal or illicit drugs more frequently than once weekly during the 4 weeks before screening.
-Other substance use disorders (excluding nicotine and caffeine), as determined by the Investigator.
-Veins unsuitable for venipuncture or cannulation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 317325 0
Commercial sector/Industry
Name [1] 317325 0
Camurus Pty Ltd
Country [1] 317325 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Camurus Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319654 0
None
Name [1] 319654 0
None
Address [1] 319654 0
Country [1] 319654 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316055 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 316055 0
Ethics committee country [1] 316055 0
Australia
Date submitted for ethics approval [1] 316055 0
06/08/2024
Approval date [1] 316055 0
19/02/2025
Ethics approval number [1] 316055 0
2024/ETH01586

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136634 0
Prof Nicholas Lintzeris
Address 136634 0
Drug & Alcohol Services, South East Sydney Local Health District, NSW Health, The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010, Sydney
Country 136634 0
Australia
Phone 136634 0
+61 419 261 675
Fax 136634 0
Email 136634 0
[email protected]
Contact person for public queries
Name 136635 0
Prof Nicholas Lintzeris
Address 136635 0
Drug & Alcohol Services, South East Sydney Local Health District, NSW Health, The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010, Sydney
Country 136635 0
Australia
Phone 136635 0
+61 419 261 675
Fax 136635 0
Email 136635 0
[email protected]
Contact person for scientific queries
Name 136636 0
Prof Nicholas Lintzeris
Address 136636 0
Drug & Alcohol Services, South East Sydney Local Health District, NSW Health, The Langton Centre, 591 South Dowling Street, Surry Hills, NSW 2010, Sydney
Country 136636 0
Australia
Phone 136636 0
+61 419 261 675
Fax 136636 0
Email 136636 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To preserve patient confidentiality



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.