Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575751
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Cannabidiol and Cannabis Concentrate Users
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cannabidiol and Cannabis Concentrate Users A Randomized Placebo Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This study is a randomized placebo-controlled dose-ranging trial of plant-derived cannabidiol CBD among people who regularly use cannabis concentrates but are not trying to stop or cut down on their use The main questions it aims to answer are whether CBD relative to placebo reduces cannabis concentrate use the subjective effects of cannabis or cannabis craving Participants will take CBD 200 mg or 400 mg per day or placebo for 4 weeks and will complete three visits during the study medication period all conducted using a mobile laboratory
Detailed Description:
The overarching aim of this proposal is to combine a naturalistic cannabis administration paradigm with a placebo-controlled dose-ranging randomized controlled trial of plant-derived cannabidiol CBD to evaluate CBD effects on cannabis concentrate use subjective effects and cannabis cue reactivity To achieve this aim 120 adult frequent concentrate users will be recruited to complete a four-week protocol during which they will complete three sessions in a mobile pharmacology laboratory Up to 200 participants may be consentedenrolled to account for screen failures and attrition In two of the sessions participants will use their typical cannabis concentrate on an ad libitum basis Amount of delta-9-tetrahydrocannabinol THC self-administration during these sessions will be quantified by THC blood levels obtained in the mobile lab immediately before and after use Subjective drug effects and exogenous and endogenous cannabinoid biomarkers will also be quantified before and after THC use Immediately after the first mobile lab session participants will be randomly assigned to take either 200 mg or 400 mg of plant-derived broad-spectrum CBD or matched placebo 40 participants per group daily for four weeks Participants will complete a second mobile lab session after two weeks to provide a blood sample that will be analyzed for cannabinoid levels At this session participants will also complete a cannabis cue reactivity paradigm Participants will complete a second mobile lab session after four weeks of study medication ingestion during which blood draws and THC self-administration will be repeated
There are three aims
Aim 1 Test the effect of CBD relative to placebo and to baseline on cannabis use over four weeks and THC self-administration in the mobile laboratory
Hypothesis 1a Both doses of CBD relative to placebo will reduce THC metabolite levels at weeks 2 and 4
Hypothesis 1b Both doses of CBD relative to placebo and to baseline will reduce the amount of THC that participants choose to consume in the mobile laboratory as assessed by pre- vs post-use THC blood levels
Aim 2 Test the effect of CBD relative to placebo and to baseline on subjective drug effects intoxication psychotomimetic symptoms anxiety and negative affect following acute cannabis concentrate use
Hypothesis 2 Both doses of CBD relative to placebo and to baseline will reduce intoxication paranoia anxiety and negative affect following acute use even after controlling for between-group differences in amount of concentrate used
Aim 3 Test the effect of CBD relative to placebo on cannabis cue-elicited craving and evaluate whether this effect mediates CBD effects on cannabis use
Hypothesis 3a Both doses of CBD relative to placebo will reduce cannabis craving
Hypothesis 3b CBDs effect on craving at week 2 will mediate its effect on THC metabolite levels at week 4
For all aims a linear effect of CBD dose is hypothesized with the greatest effects in the 400 mg CBD group Successful achievement of these aims will allow determination of an efficacious dose of CBD that reduces high-THC cannabis use subjective drug effects and craving setting the stage for a subsequent RCT of plant-derived CBD to treat these outcomes in treatment-seeking high-THC cannabis concentrate users
There are three aims
Aim 1 Test the effect of CBD relative to placebo and to baseline on cannabis use over four weeks and THC self-administration in the mobile laboratory
Hypothesis 1a Both doses of CBD relative to placebo will reduce THC metabolite levels at weeks 2 and 4
Hypothesis 1b Both doses of CBD relative to placebo and to baseline will reduce the amount of THC that participants choose to consume in the mobile laboratory as assessed by pre- vs post-use THC blood levels
Aim 2 Test the effect of CBD relative to placebo and to baseline on subjective drug effects intoxication psychotomimetic symptoms anxiety and negative affect following acute cannabis concentrate use
Hypothesis 2 Both doses of CBD relative to placebo and to baseline will reduce intoxication paranoia anxiety and negative affect following acute use even after controlling for between-group differences in amount of concentrate used
Aim 3 Test the effect of CBD relative to placebo on cannabis cue-elicited craving and evaluate whether this effect mediates CBD effects on cannabis use
Hypothesis 3a Both doses of CBD relative to placebo will reduce cannabis craving
Hypothesis 3b CBDs effect on craving at week 2 will mediate its effect on THC metabolite levels at week 4
For all aims a linear effect of CBD dose is hypothesized with the greatest effects in the 400 mg CBD group Successful achievement of these aims will allow determination of an efficacious dose of CBD that reduces high-THC cannabis use subjective drug effects and craving setting the stage for a subsequent RCT of plant-derived CBD to treat these outcomes in treatment-seeking high-THC cannabis concentrate users
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