Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02759185
Status:
COMPLETED
Last Update Posted:
2023-07-12
First Post:
2016-04-29
Brief Title:
Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With PTSD
Sponsor:
Multidisciplinary Association for Psychedelic Studies
Organization:
Multidisciplinary Association for Psychedelic Studies
Study Overview
Official Title:
Placebo-Controlled Triple-Blind Randomized Crossover Pilot Study of the Safety and Efficacy of Four Different Potencies of Smoked Marijuana in 76 Veterans With Chronic Treatment-Resistant Posttraumatic Stress Disorder PTSD
Status:
COMPLETED
Status Verified Date:
2023-07
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:
None
Brief Summary:
This pilot study gathered preliminary evidence of the safety and efficacy of four potencies of smoked cannabis to manage chronic treatment-resistant PTSD among veterans 1 High THC Low CBD High THC 2 Low THCHigh CBD High CBD 3 High THC High CBD THCCBD and 4 Low THCLow CBD placebo The study will produce preliminary evidence to help elucidate the potential effects of THC CBD or a combination of both constituents to reduce PTSD symptoms Smoked cannabis will be tested in two stages of three weeks each Stage 1 and Stage 2 with a two-week cessation period after each stage verified by bloodurine cannabinoid analysis The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1
Detailed Description:
PTSD is a serious worldwide public health problem resulting from traumatic experiences such as sexual assault war or abuse PTSD is associated with high rates of psychiatric and medical co-morbidity disability suffering and suicide Despite available treatments for PTSD many individuals continue to experience marked PTSD symptoms following treatment In response to overwhelming demand for new treatments several US states have passed laws allowing the medical use of cannabis by individuals with PTSD
Emerging observational and early clinical evidence suggest that cannabis may have the potential to reduce or ameliorate a number of symptoms experienced by those with PTSD including sleep difficulty and anxiety Indeed some evidence has suggested that delta-9-tetrahydrocannabinol THC may serve to reduce nightmares among those with PTSD while other studies have shown anxiolytic effects of cannabidiol CBD However there have been no randomized controlled trials of cannabis in any form for PTSD
The present triple-blind randomized placebo-controlled crossover trial aims to examine the safety and efficacy of four types of cannabis ie high THC low CBD high CBD low THC equal ratio THCCBD and placebo among 76 military veterans with chronic treatment-resistant PTSD of at least six months duration The study will produce preliminary evidence to help elucidate the contribution of THC CBD or a combination of both constituents to potential attenuation of PTSD symptoms
Smoked cannabis was tested in two stages lasting three weeks each Stage 1 and Stage 2 with a two-week cessation after each stage verified by bloodurine cannabinoid analysis The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total scores during Stage 1
Study participants received one of four different types of cannabis during Stage 1 with crossover and re-randomization less the placebo cannabis at Stage 2 The four potencies of cannabis were High THC Low CBD High THC Low THCHigh CBD High CBD High THCHigh CBD THCCBD and Low THCLow CBD placebo High is defined as marijuana containing a target of 7-15 concentration by weight of the respective cannabinoid and Low is defined as 2 concentration by weight Prior to each stage participants completed two introductory sessions where they were trained on cannabis self-administration During each stage participants were provided 18 grams of cannabis daily to smoke ad libitum Each stage was followed by a two-week cessation period
The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1
Emerging observational and early clinical evidence suggest that cannabis may have the potential to reduce or ameliorate a number of symptoms experienced by those with PTSD including sleep difficulty and anxiety Indeed some evidence has suggested that delta-9-tetrahydrocannabinol THC may serve to reduce nightmares among those with PTSD while other studies have shown anxiolytic effects of cannabidiol CBD However there have been no randomized controlled trials of cannabis in any form for PTSD
The present triple-blind randomized placebo-controlled crossover trial aims to examine the safety and efficacy of four types of cannabis ie high THC low CBD high CBD low THC equal ratio THCCBD and placebo among 76 military veterans with chronic treatment-resistant PTSD of at least six months duration The study will produce preliminary evidence to help elucidate the contribution of THC CBD or a combination of both constituents to potential attenuation of PTSD symptoms
Smoked cannabis was tested in two stages lasting three weeks each Stage 1 and Stage 2 with a two-week cessation after each stage verified by bloodurine cannabinoid analysis The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total scores during Stage 1
Study participants received one of four different types of cannabis during Stage 1 with crossover and re-randomization less the placebo cannabis at Stage 2 The four potencies of cannabis were High THC Low CBD High THC Low THCHigh CBD High CBD High THCHigh CBD THCCBD and Low THCLow CBD placebo High is defined as marijuana containing a target of 7-15 concentration by weight of the respective cannabinoid and Low is defined as 2 concentration by weight Prior to each stage participants completed two introductory sessions where they were trained on cannabis self-administration During each stage participants were provided 18 grams of cannabis daily to smoke ad libitum Each stage was followed by a two-week cessation period
The primary objective was to compare three active concentrations of smoked cannabis and placebo on PTSD symptom severity measured by CAPS-5 total severity scores during Stage 1
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