CAM2038 in Adult Outpatients with Opioid Use Disorder
Research type
Research Study
Full title
An Open-Label Multicentre Study Assessing the Long-Term Safety of a Once-Weekly and Once-Monthly, Long-Acting Subcutaneous Injection Depot of Buprenorphine (CAM2038) in Adult Outpatients with Opioid Use Disorder
IRAS ID
188004
Contact name
Sonnie Kim
Contact email
Sponsor organisation
Braeburn Pharmaceuticals
Eudract number
2015-003035-35
Duration of Study in the UK
1 years, 7 months, 4 days
Research summary
Opioids are medications that relieve pain. Properly managed, short-term medical use of opioids rarely cause addiction, however regular or longer term use or abuse (taking the drug in ways other than those prescribed) of opioids can lead to physical dependence. When abused, even a single large dose can cause severe breathing problems and death. Withdrawal symptoms such as muscle and bone pain, insomnia, and cold flushes can all occur if the drug is suddenly reduced or stopped.
Opioid drug dependence is a major health and social issue that requires long-term maintenance treatment to make the patients stop abusing drugs, as well as improving their mental and physical health.
Opioid maintenance treatment, such as sublingual buprenorphine, is currently one of the most effective treatment options, approved by the National Institute for Health and Care Excellence (NICE), for opioid dependent drug users to relieve opioid withdrawal symptoms. However because patients often discontinue treatment prematurely, perhaps due to having to take the drug daily and because the tablets can be easily diverted, there are high rates of relapse to drug use.
Braeburn Pharmaceuticals have developed new buprenorphine weekly and monthly injections which release buprenorphine over an extended period of time. Buprenorphine injections have rapid onset followed by steady long-acting release resulting in more consistent levels in the blood and less likelihood of ‘cravings’. They provide alternative treatment that potentially can increase patient compliance compared to daily sublingual buprenorphine.
This study is being done to look at the safety and tolerability of buprenorphine weekly and monthly injections when received for 12 months in adults with opioid use who are currently taking or seeking sublingual buprenorphine treatment.
This is a multicentre study which will take place across Europe and Asia Pacific. It is anticipated that approximately 160 patients will be enrolled worldwide, 22 of those in the UK.REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/1653
Date of REC Opinion
9 Nov 2015
REC opinion
Further Information Favourable Opinion