None listed
Conditions
Brief summary
This study is looking at a new experimental approach for transferring patients from methadone to CAM2038. The purpose of the study is to test if patients with opioid dependence who are treated with a methadone dose of above 30 mg per day to 100 mg per day can be transferred to CAM2038 without reducing the dose of methadone before they start CAM2038. After starting CAM2038 treatment, the methadone dose is then reduced over several days. The main outcome of the study is to see how many participants that proceed to the standard treatment dosing with CAM2038 after one week of treatment with both CAM2038 and methadone. The study hypothesis is that patients can start treatment with CAM2038 without having to reduce their methadone dose below 30 mg before the first dose of CAM2038.
Interventions
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 t
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.
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. The methadone dose on Day 1 can be given either as the full dose in the morning, or as half of the dose in the morning and the other half 6 to 12 hours later, as per the Investigator’s decision. Starting
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. The methadone dose on Day 1 can be given either as the full dose in the morning, or as half of the dose in the morning and the other half 6 to 12 hours later, as per the Investigator’s decision. 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 individual participant's needs). 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 or more doses, at least 1 day apart, up to a maximum total dose of 40 mg CAM2038 during the 7-day period). 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.
Sponsors
Camurus Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed