Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823753
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-04-10
Brief Title:
Cannabidiol to Reduce Anxiety Reactivity
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Endocannabinoid System Engagement to Reduce Anxiety Reactivity With Cannabidiol in Social Anxiety Disorder R61 Project
Status:
COMPLETED
Status Verified Date:
2024-08
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 study seeks to understand how cannabidiol CBD - a non-intoxicating chemical compound obtained from the Cannabis sativa plant - affects biological and stress-related responses that are believed to underlie anxiety disorders This study will evaluate the effects of different doses of CBD on blood plasma levels of anandamide a molecule in the brain that has been shown to help regulate stress responses primary biological signature and anxiety reactivity to a standardized stress task secondary target in an acute 4-day dosing study ie when steady state CBD levels have been reached Approximately 60 subjects with social anxiety disorder SAD ages 18-70 will participate in this study They will be assigned by chance to receive one of two doses of CBD 150 mg BID or 450 mg BID administered in two divided doses daily or placebo which resembles the study drug but has no active ingredients BID for 3 days and on the morning of day 4 Knowledge gained from this study will help determine the therapeutic potential of CBD for anxiety
Detailed Description:
Background and aims
The proposed two-phase milestone driven project seeks to understand how cannabidiol CBD effects biological and stress-related responses that are believed to underlie anxiety disorders This knowledge will help advance the therapeutic potential of CBD for anxiety The R61 phase project will evaluate the dose-dependent effects of CBD on blood plasma levels of anandamide a molecule in the brain that has been shown to help regulate stress responses primary biological signature and anxiety reactivity to a standardized stress task secondary target in an acute 4-day dosing study ie when steady state CBD levels have been reached Aim 1 will test the hypothesis that CBD increases anandamide levels and decreases anxiety reactivity compared to placebo Aim 2 will determine which dose 150 mg BID or 450 mg BID of CBD produces a greater effect on anandamide and anxiety reactivity To achieve these aims 60 participants meeting diagnostic criteria for social anxiety disorder SAD will be randomized 111 to one of two doses of CBD 300 mgday or 900 mgday or placebo They will complete standardized paradigms assessing anxiety reactivity and blood draws for determination of CBD and anandamide levels at baseline and day 4
Research design and procedures
This phase II clinical trial will randomize 60 subjects using a double-blind parallel group design 111 to CBD 300 mgday or 900 mgday or placebo Randomization will be stratified by sex assigned at birth Study personnel and subjects will be blinded throughout Only the study biostatistician and pharmacist will be unblinded
Session 1 intake session will involve explanation of study procedures informed written consent a clinical evaluation a series of questionnaires medical exam and history including current treatments and urine and blood test This session will determine eligibility to take part in the study
Session 2 baseline assessment session will include vital signs urine test blood draw to assess plasma CBD and endocannabinoid metabolites state mood assessments computerized tasks assessing responses to emotional faces and reactivity to a standardized stress task At the end of this session subjects will receive their CBDplacebo dispensation kit and instructions for taking CBDplacebo from the study physician The CBD product to be used in this study is Epidiolex Jazz PharmaceuticalsGreenwich a plant-derived highly purified CBD oral solution that is FDA approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older Participants will receive CBD or placebo oral solution twice daily evenly split doses at morning and evening meals for three days to achieve steady state following the baseline assessment day 0
Session 3 post-test session will occur on the morning of day 4 time of day matched to baseline 1h Participants will be instructed to take their morning dose with a meal as done in previous days Post-test assessments will be the same as those taken at baseline including blood draw urine test state mood assessments computerized tasks assessing responses to emotional faces and reactivity to a standardized stress task Frequency of adverse and serious adverse events AESAEs and medication adherence will be assessed by the study physician At the end of this session subjects will be debriefed and referred for additional care as appropriate
The proposed two-phase milestone driven project seeks to understand how cannabidiol CBD effects biological and stress-related responses that are believed to underlie anxiety disorders This knowledge will help advance the therapeutic potential of CBD for anxiety The R61 phase project will evaluate the dose-dependent effects of CBD on blood plasma levels of anandamide a molecule in the brain that has been shown to help regulate stress responses primary biological signature and anxiety reactivity to a standardized stress task secondary target in an acute 4-day dosing study ie when steady state CBD levels have been reached Aim 1 will test the hypothesis that CBD increases anandamide levels and decreases anxiety reactivity compared to placebo Aim 2 will determine which dose 150 mg BID or 450 mg BID of CBD produces a greater effect on anandamide and anxiety reactivity To achieve these aims 60 participants meeting diagnostic criteria for social anxiety disorder SAD will be randomized 111 to one of two doses of CBD 300 mgday or 900 mgday or placebo They will complete standardized paradigms assessing anxiety reactivity and blood draws for determination of CBD and anandamide levels at baseline and day 4
Research design and procedures
This phase II clinical trial will randomize 60 subjects using a double-blind parallel group design 111 to CBD 300 mgday or 900 mgday or placebo Randomization will be stratified by sex assigned at birth Study personnel and subjects will be blinded throughout Only the study biostatistician and pharmacist will be unblinded
Session 1 intake session will involve explanation of study procedures informed written consent a clinical evaluation a series of questionnaires medical exam and history including current treatments and urine and blood test This session will determine eligibility to take part in the study
Session 2 baseline assessment session will include vital signs urine test blood draw to assess plasma CBD and endocannabinoid metabolites state mood assessments computerized tasks assessing responses to emotional faces and reactivity to a standardized stress task At the end of this session subjects will receive their CBDplacebo dispensation kit and instructions for taking CBDplacebo from the study physician The CBD product to be used in this study is Epidiolex Jazz PharmaceuticalsGreenwich a plant-derived highly purified CBD oral solution that is FDA approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older Participants will receive CBD or placebo oral solution twice daily evenly split doses at morning and evening meals for three days to achieve steady state following the baseline assessment day 0
Session 3 post-test session will occur on the morning of day 4 time of day matched to baseline 1h Participants will be instructed to take their morning dose with a meal as done in previous days Post-test assessments will be the same as those taken at baseline including blood draw urine test state mood assessments computerized tasks assessing responses to emotional faces and reactivity to a standardized stress task Frequency of adverse and serious adverse events AESAEs and medication adherence will be assessed by the study physician At the end of this session subjects will be debriefed and referred for additional care as appropriate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None