Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544291
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Combined THC and CBD for OUD and Chronic Pain
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combination of THC and CBD as Novel Treatment for Co-Occurring Opioid Use Disorder and Chronic Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this phase 2 study is to investigate the therapeutic potential of orally administered combined delta-9-tetrahydrocannabinol THC and cannabidiol CBD in relieving both pain and cue-induced opioid craving in people with co-occurring opioid use disorder OUD and chronic pain who are undergoing methadone therapy
Detailed Description:
This phase 2 study will utilize a rigorous double-blind placebo-controlled crossover experimental design We will enroll 147 participants with co-occurring OUD and chronic pain who are receiving methadone maintenance treatment and randomize them into three groups n49 Across three test sessions each group will receive single doses of THC 5 mg 10 mg or placebo and CBD 300 mg 600 mg or placebo in a 3x3 design with THC dose as a between-subject parallel-group factor and CBD dose as within-subject crossover factor All three groups will undergo otherwise identical procedures to ensure internal validity
Our central hypothesis posits that combined THC and CBD will be more effective in alleviating pain and cue-induced opioid craving than either drug alone While THCs analgesic effects may benefit those with co-occurring OUD and chronic pain its abuse potential and cognitivepsychomotor deficits require careful dose consideration Combining THC with non-hedonic and neuroprotective CBD could offer a compelling two-pronged approach to alleviate both pain and opioid craving This study will also explore if sex influences the responses to THC and CBD given the growing evidence indicating sex-specific effects of cannabinoids and pain responses If our hypothesis is confirmed selected THCCBD doses may serve as a novel dual-action therapy to alleviate both pain and opioid craving in co-occurring OUD and chronic pain
Our central hypothesis posits that combined THC and CBD will be more effective in alleviating pain and cue-induced opioid craving than either drug alone While THCs analgesic effects may benefit those with co-occurring OUD and chronic pain its abuse potential and cognitivepsychomotor deficits require careful dose consideration Combining THC with non-hedonic and neuroprotective CBD could offer a compelling two-pronged approach to alleviate both pain and opioid craving This study will also explore if sex influences the responses to THC and CBD given the growing evidence indicating sex-specific effects of cannabinoids and pain responses If our hypothesis is confirmed selected THCCBD doses may serve as a novel dual-action therapy to alleviate both pain and opioid craving in co-occurring OUD and chronic pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None