Cannabidiol for Cannabis Use
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how cannabidiol (CBD) affects cannabis, particularly regarding behavior and pain relief. Participants will receive various combinations of active or inactive CBD and cannabis to assess their effects. The trial suits individuals who use cannabis recreationally, are otherwise healthy, are not seeking treatment for drug use, and are comfortable with procedures like drug testing. As an Early Phase 1 trial, this research aims to understand CBD's interaction with cannabis in people, offering participants the opportunity to contribute to groundbreaking insights.
Will I have to stop taking my current medications?
Yes, if you are currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study, you may need to stop taking them. The trial excludes participants who are on such medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cannabidiol (CBD) is usually safe for use. In one study, some participants taking up to 25 mg of CBD per kilogram of body weight daily experienced higher liver enzyme levels, indicating potential liver stress, though this did not occur in all cases. Another report from poison centers mentioned over 400 CBD-related cases in a year, but without detailed results, firm conclusions remain elusive. Mixing CBD with alcohol or other drugs can increase the risk of side effects. While the FDA has approved CBD for specific uses, such as treating certain seizure disorders, its safety for other uses remains uncertain. Consider these points when deciding to join a trial.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they explore the effects of cannabidiol (CBD) and inhaled cannabis in various combinations and doses. Unlike many current treatments for conditions that might benefit from cannabis, which often involve synthetic cannabinoids or isolated compounds, this approach uses active CBD and cannabis directly derived from the plant. This trial investigates how different combinations and doses may impact outcomes, giving us insights into the potential therapeutic effects of natural cannabis components. Additionally, the focus on vaporized administration offers a unique delivery method that might provide rapid onset of effects compared to traditional oral medications.
What evidence suggests that this trial's treatments could be effective for pain relief and behavioral effects?
Research has shown that cannabidiol (CBD) might help lower anxiety and manage addiction for some people. Studies have found that medium doses of CBD (300–400 mg) can reduce anxiety. Higher doses, such as 400 to 600 mg, are also linked to less anxiety and more relaxation. CBD is generally safe for short-term use, and many studies suggest it can help with issues like pain and trouble sleeping. While the evidence is promising, effects can differ from person to person. In this trial, participants will receive varying doses of CBD, either alone or with active or inactive inhaled cannabis, to evaluate its effects further.678910
Who Is on the Research Team?
Hannah M Harris, Ph.D.
Principal Investigator
University of Kentucky
Are You a Good Fit for This Trial?
This trial is for adults aged 18-55 who are generally healthy, use cannabis recreationally (not just medically), and are not currently seeking treatment for drug use. Participants must not have serious medical or psychiatric conditions, recent synthetic cannabis use, or dependence on certain drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various combinations of active and placebo cannabidiol and marijuana to assess effects on cannabis abuse liability and analgesia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cannabidiol
Trial Overview
The study tests how different doses of cannabidiol (CBD) affect the effects of inhaled cannabis compared to placebo versions. It uses a randomized design where participants receive various combinations of CBD and cannabis in an outpatient setting.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day. Inactive/Placebo Cannabidiol: Active cannabidiol will be administered orally. Active Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer.
Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Vaporized Marijuana: Active Marijuana administered through a vaporizer Cannabidiol: Active cannabidiol will be administered orally
Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Active Marijuana: Active Marijuana will be administered through a vaporizer.
Participants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day. Inactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally. Inactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hannah Harris
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Cannabidiol usage, efficacy, and side effects - PMC - NIH
The data on daily CBD dosage showed that the majority of participants (36.5%) reported not knowing their daily dosage. Among those who ...
Dosage, Efficacy and Safety of Cannabidiol Administration in ...
Single oral doses of 400 and 600 mg decreased anxiety and increased mental sedation measured with visual analogue mood scale in two individually randomized ...
A systematic review of cannabidiol dosing in clinical populations
A positive effect of CBD was reported in 66% of studies, covering disorders including schizophrenia, SAD, epilepsy, cannabis dependency and graft‐vs‐host ...
4.
health.harvard.edu
health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-201808242496Cannabidiol (CBD): What we know and what we don't
... it does not cause a high and is not addictive. CBD has been shown to be effective in treating conditions like pain, insomnia, and anxiety.
5.
frontiersin.org
frontiersin.org/research-topics/69854/expanding-the-therapeutic-dose-range-of-cannabinoid-based-therapyundefinedExpanding the therapeutic dose range of cannabinoid- ...
Through this Research Topic, we seek to address key challenges associated with CBD dosing by promoting research into strategies that improve its dose-efficacy ...
Safety Data Sheet
Article number: 90080. · Application of the substance / the mixture. This product is for research use - Not for human or veterinary diagnostic ...
Cannabidiol Safety Data: A Systematic Mapping Study
We have developed the first systematic map of the safety-related information available for CBD in the peer-reviewed literature.
Cannabidiol (CBD) – Potential Harms, Side Effects, and ...
Do not use CBD concurrently with medications, alcohol, or illicit drugs. ○ If you experience adverse events as a result of using CBD products, report them to ...
9.
fda.gov
fda.gov/drugs/regulatory-science-action/cder-investigators-address-safety-cbd-randomized-trialCDER Investigators Address the Safety of CBD in a ...
At labeled doses up to 25 mg/kg/day, an increased risk of liver enzyme elevation was observed., Liver enzyme elevations typically occurred after ...
About CBD | Cannabis and Public Health
Using CBD products is not risk free. The FDA has limited data on CBD safety. Please consider these possible side effects and risks before ...
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