23 Participants NeededMy employer runs this trial

Cannabidiol for Cannabis Use

PA
Overseen ByPaul A Nuzzo, M.A.

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?

HM

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

I am male or female.
Body Mass Index from 18.5-32.0 kg/m2
I am between 18 and 55 years old.
See 6 more

Exclusion Criteria

I have a physical dependence on opioids, benzodiazepines, barbiturates, or alcohol needing medical care.
I have a serious medical condition that needs daily medication or ongoing care.
I do not have a major psychiatric disorder that would prevent me from joining the study.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various combinations of active and placebo cannabidiol and marijuana to assess effects on cannabis abuse liability and analgesia

2 weeks
Sessions on Days 1, 7, and 14

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Placebo CBD/Active Inhaled CannabisExperimental Treatment2 Interventions
Group II: CBD (Medium Dose)/Placebo Inhaled CannabisExperimental Treatment2 Interventions
Group III: CBD (Medium Dose)/Active Inhaled CannabisExperimental Treatment2 Interventions
Group IV: CBD (Higher Dose)/Placebo Inhaled CannabisExperimental Treatment2 Interventions
Group V: CBD (Higher Dose)/Active Inhaled CannabisExperimental Treatment2 Interventions
Group VI: Placebo CBD/Placebo Inhaled CannabisPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hannah Harris

Lead Sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

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 ...

Cannabidiol (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.

Expanding 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 ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36251454/

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 ...

CDER 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 ...