Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05985850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-07-26
Brief Title:
Evaluating Tetrahydrocannabinol as an Adjunct to Opioid Agonist Therapy
Sponsor:
BC Centre on Substance Use
Organization:
BC Centre on Substance Use
Study Overview
Official Title:
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 THC-MMT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THC-MMT
Brief Summary:
This pilot study will evaluate the feasibility and safety of using 11 tetrahydrocannabinol THCCannabidiol CBD cannabis oil as an adjunct therapy to methadone-based Opioid Agonist Therapy OAT for individuals with opioid use disorder OUD in a community setting
Detailed Description:
This is a single-site two-phase pilot clinical trial evaluating the safety and feasibility of administering a balanced 11 ratio of THCCBD cannabis oil alongside methadone-based opioid agonist therapy OAT in a community setting
Phase 1 is a 12-week double-blind randomized controlled study involving 24 eligible participants with opioid use disorder OUD who recently initiated or re-initiated methadone-based OAT Participants will be randomly assigned to receive either balanced THCCBD cannabis oil or placebo oil All participants will receive OUD clinical care including OAT management independent of research visits
After the 12-week blinded treatment period Phase 1 eligible participants will be invited to Phase 2 a 12-week open-label treatment extension study with all participants receiving balanced THCCBD cannabis oil Follow-up research visits will occur every two weeks from the start of open-label treatment
Phase 1 is a 12-week double-blind randomized controlled study involving 24 eligible participants with opioid use disorder OUD who recently initiated or re-initiated methadone-based OAT Participants will be randomly assigned to receive either balanced THCCBD cannabis oil or placebo oil All participants will receive OUD clinical care including OAT management independent of research visits
After the 12-week blinded treatment period Phase 1 eligible participants will be invited to Phase 2 a 12-week open-label treatment extension study with all participants receiving balanced THCCBD cannabis oil Follow-up research visits will occur every two weeks from the start of open-label treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None