Grant: Project Grant
University of British Columbia
$279,224.00
Evaluating tetrahydrocannabinol as an adjunct to opioid agonist therapy for individuals living with opioid use disorder: A Phase II, placebo-controlled, blinded, pilot study to assess safety and feasibility
EF 2019-20
Résumé
Communities across Canada are grappling with the opioid overdose crisis. Sparked by the contamination of the illicit drug supply with fentanyl, the crisis has claimed more than 14,000 lives since 2015, many of them individuals living with opioid use disorder.
Medications like methadone are the best available treatment for opioid use disorder and have been shown to lower the risk of death from opioid overdose. However, methadone requires daily ingestion and improvements are needed to increase its beneficial impacts and reduce the risk of patients consuming illicit opioids like fentanyl. In preliminary studies, we have observed that people on methadone using cannabis were more likely to stay on methadone and less likely to use fentanyl.
In the current study, we propose to test the safety, tolerability, and feasibility of giving people in treatment for opioid use disorder cannabis alongside daily methadone. The study will recruit 24 people on methadone in Vancouver's Downtown Eastside who are interested in taking cannabis (specifically, a high THC/low CBD oil taken orally) along with daily methadone. During the study, they will get their daily methadone dose and, at random, either a high THC/low CBD oil or an identical oil without active ingredients (i.e., a placebo.) The study will last for 12 weeks and compare safety, tolerability, between people who received cannabis and those who received placebo. At the end of 12 weeks, participants adherent to the study protocol will be offered another 12 weeks on cannabis. There will be no cost for participating in this trial.
This pilot study is an innovative proposal to try and improve treatment for people with opioid use disorder at high risk of overdose. It will not only help patients and care providers better understand cannabis use during methadone treatment, but also advance efforts to address Canada's overdose crisis.
Programme
Project Grant
Bénéficiaire
Emplacement
British Columbia, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database
Tel que publié
Id
420760
Name
Milloy Michael-John S
Region
British Columbia
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Neurosciences, Mental Health and Addiction
Theme2
Clinical
Prcname2
Behavioural Sciences - B: Clinical Behavioural Sciences
Projecttitle
Evaluating tetrahydrocannabinol as an adjunct to opioid agonist therapy for individuals living with opioid use disorder: A Phase II, placebo-controlled, blinded, pilot study to assess safety and feasibility
Programtype2
Operating Grants
Orgnameinp2
University of British Columbia
Cihramount2
$279,224
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Addiction; Cannabinoids; Clinical Trials; Opioid Use Disorder
Abstract
Communities across Canada are grappling with the opioid overdose crisis. Sparked by the contamination of the illicit drug supply with fentanyl, the crisis has claimed more than 14,000 lives since 2015, many of them individuals living with opioid use disorder.
Medications like methadone are the best available treatment for opioid use disorder and have been shown to lower the risk of death from opioid overdose. However, methadone requires daily ingestion and improvements are needed to increase its beneficial impacts and reduce the risk of patients consuming illicit opioids like fentanyl. In preliminary studies, we have observed that people on methadone using cannabis were more likely to stay on methadone and less likely to use fentanyl.
In the current study, we propose to test the safety, tolerability, and feasibility of giving people in treatment for opioid use disorder cannabis alongside daily methadone. The study will recruit 24 people on methadone in Vancouver's Downtown Eastside who are interested in taking cannabis (specifically, a high THC/low CBD oil taken orally) along with daily methadone. During the study, they will get their daily methadone dose and, at random, either a high THC/low CBD oil or an identical oil without active ingredients (i.e., a placebo.) The study will last for 12 weeks and compare safety, tolerability, between people who received cannabis and those who received placebo. At the end of 12 weeks, participants adherent to the study protocol will be offered another 12 weeks on cannabis. There will be no cost for participating in this trial.
This pilot study is an innovative proposal to try and improve treatment for people with opioid use disorder at high risk of overdose. It will not only help patients and care providers better understand cannabis use during methadone treatment, but also advance efforts to address Canada's overdose crisis.
Competitiondate
202003
Approvedterm2
3 yrs 0 mth
Pinamesdelim
Milloy, Michael-John S; Socías, María E
Approvedterm
3 ans 0 mois
Cihrcontribution2
~ $279,224~ $0~