A Study of Cannabidiol in Young Adult Cannabis Users
A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users
Sponsor study identifier
Secondary identifiers
NIH
interventional
200
1 country
1
Study Start
December 9, 2024
Actual (reported)Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 22, 2024
Actual (reported)August 26, 2024
Actual (reported)December 9, 2024
Actual (reported)June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Difference in blood THC-COOH levels
THC-COOH levels in blood samples collected at baseline, Week 4, and Week 8 of medication ingestion.
8 weeks
Difference in blood THC levels
THC levels in blood samples collected before and after cannabis use at baseline, Week 4, and Week 8 of medication ingestion.
1 hour pre and post THC self-administration at baseline, 4 weeks, and 8 weeks
Difference in cannabis use
Total number of days of cannabis use during the 8-week medication period as reported on daily diaries.
8 Weeks
Adverse effects
8 weeks
Difference in blood CBD levels
8 weeks
bsCBD in a 400 mg dose will be used as described in the study arms.
A medically inert placebo medication will be used as described in the study arms.
Participants in this Arm will take 400 mg of bsCBD daily. Participants will take medication by mouth with food in the morning and evening.
Participants in this Arm will take a medically inert placebo. Participants will take medication by mouth with food in the morning and evening.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Christian J Hopfer, MD
University of Colorado, Denver
First Submitted
August 22, 2024
First Posted
August 26, 2024
Study Start
December 9, 2024
Actual (reported)Sex Differences in Neurobehavioral Response to THC
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 1, 2026
Record last verified: 2026-04
Data will be shared through a NIDA P50 data sharing resource.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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