None listed
Conditions
Brief summary
The study examines patient outcomes and experiences in the use of depot buprenorphine formulation (Buvidal) in the treatment of patients with concurrent opioid dependence and chronic pain conditions using a prospective case series. Specifically the study will compare outcomes and experiences of patients before and after transfer from other opioid medications to Buvidal® treatment on the following measures: 1. Patient reported pain outcomes including measures of pain severity and pain interference using the Brief Pain Inventory (primary outcome); 2. Secondary outcomes include patient reported substance use (ATOP), general health and quality of life outcomes (PROMIS-29), adverse events, and patient satisfaction measures (TSQM), and use of other medications for pain management. These outcomes will be examined at baseline (in period before transferring to depot buprenorphine), and at 4 weekly intervals for 12 weeks following the first dose of depot buprenorphine, during which depot treatment will be continued. A prospective case series of patients treated in South East Sydney Local Health District Drug and Alcohol Services and Prince of Wales Hospital Department of Pain Management.
Interventions
The study involves the administration of depot buprenorphine subcutaneous injections to opioid dependent patients with concurrent chronic pain, and monitoring of a range of health outcomes and patient satisfaction measures over a 12 week treatment period following the first dose.
The dose of depot buprenorphine will be individualised, ranging from 8, 16, 24 or 32mg Weekly doses and/or 64, 96, 128 or 160mg Monthly doses. Doses will be titrated according to dose and type of opioid medication fr
The study involves the administration of depot buprenorphine subcutaneous injections to opioid dependent patients with concurrent chronic pain, and monitoring of a range of health outcomes and patient satisfaction measures over a 12 week treatment period following the first dose. The dose of depot buprenorphine will be individualised, ranging from 8, 16, 24 or 32mg Weekly doses and/or 64, 96, 128 or 160mg Monthly doses. Doses will be titrated according to dose and type of opioid medication from which the patient is transferring from. Participants will be transferring from either sublingual buprenorphine, oral methadone or oral opioid anaglesics (e.g. oxycodone, morphine), and the dose of depot buprenorphine will be determined according to NSW Health Clinical Guidelines on the use of depot buprenorphine (2019). Depot buprenorphine doses will be continued for the duration of the study - 12 weeks, with the expectation that participants will be routinely treated with Monthly doses, although Weekly doses may be used in the first 1-4 weeks following transfer from other opioid medications. Participants will be reviewed by Addiction Medicine specialists at a minimum of 4 weekly appointments over the 12 week period. These will routinely be conducted face to face, however may be conducted by telehealth due to travel and/or social isolation restrictions. Participants will receive depot buprenorphine injections by Drug and Alcohol nursing staff at participating sites - namely public sector specialist outpatient alcohol and drug treatment services. All medications are administered at the participating sites, enabling adherence to be monitored.
Sponsors
South East Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients treated in participating services with (a) co-existing chronic pain; defined as persistent or recurring pain lasting longer than 3 months and (b) a history of opiate dependence, and (c) who transfer from an opioid medication (e.g. opioid analgesics, methadone, sublingual buprenorphine) to depot buprenorphine medication using the formulation Buvidal®.
Exclusion criteria
Exclusions include people under the age of 18, those with acute and/or severe health conditions requiring immediate treatment, pregnancy or breastfeeding.
Outcome results
None listed