Examining the effects of CBD on cannabis use in young adults

A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users

This study is testing if CBD can help young adults who regularly use cannabis feel better and reduce the negative effects of their cannabis use.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 25 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Drugs / interventions: pexidartinib, prednisone
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT06569394 on ClinicalTrials.gov

What this trial studies

This study investigates the harm-reducing effects of hemp-derived cannabidiol (CBD) in young adults who regularly use cannabis but are not seeking treatment. Utilizing a naturalistic cannabis administration approach, participants will be assessed in a mobile lab setting to evaluate the impact of CBD on various harms associated with cannabis use, including mood, cognitive functioning, and self-administration of THC. The study will recruit emerging adults aged 18-25, dividing them into groups based on their primary cannabis product use, and randomly assigning them to receive either CBD or a placebo.

Who should consider this trial

Good fit: Ideal candidates are emerging adults aged 18-25 who use cannabis flower or concentrates at least five days a week and exhibit symptoms of cannabis use disorder.

Not a fit: Patients who are actively seeking to reduce or stop cannabis use or those with significant psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-abstinence-based approach to reducing harms associated with cannabis use in young adults.

How similar studies have performed: While there is ongoing research into CBD's effects on cannabis use, this specific approach utilizing a naturalistic setting is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Ages 18-25
2. Must have used cannabis flower or concentrates at least five days per week for the past year.
3. Currently not seeking to cut down or stop cannabis use
4. At least two symptoms of a DSM-5 cannabis use disorder

Exclusion Criteria:

1. Use of any illicit substance besides alcohol, nicotine, or cannabis (e.g., cocaine, opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 60 days, as indicated by self-report and urine toxicology screening at the beginning of each study visit.
2. Alcohol use on 3 or more days per week, and/or \>3 drinks per drinking day in the past 60 days. Participants must also have a breath alcohol level of 0 at the beginning of each study visit.
3. Daily nicotine use.
4. Meets DSM-5 diagnostic criteria for a psychotic disorder (e.g., schizophrenia, schizophreniform disorder, schizoaffective disorder), bipolar disorder, major depression with suicidal ideation, or a history of treatment for these disorders.
5. Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease)
6. Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medication.
7. Current use of anti-epileptic medications (e.g., clobazam, sodium valproate) or medications known to have major interactions with Epidiolex (buprenorphine, leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib, propoxyphene, sodium oxybate, and/or teriflunomide) or a history of seizures.
8. Current use of strong or moderate CYP3A4 inhibitors or inducers (commonly used examples not captured by other exclusion criteria include protease inhibitors, macrolide antibiotics \[e.g., erythromycin\], azole antifungals \[e.g., ketoconazole\], verapamil, and grapefruit juice).
9. Current use of strong or moderate CYP2C19 inhibitors or inducers (commonly used examples not captured by other exclusion criteria include proton pump inhibitors, prednisone, and norethisterone).
10. Current or past hepatocellular disease, as indicated by medical history or alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin greater than two times the upper limit of the normal range at screening.
11. For female participants, pregnancy or trying to become pregnant. A positive pregnancy test at the beginning of any study visit will result in exclusion from ongoing study participation.
12. For female participants, currently lactating.
13. For female patients of childbearing potential, not willing to use at least one approved method of birth control while taking the study medication, unless she is surgically sterile, partner is surgically sterile, or she is postmenopausal (one year).
14. Current suicidality risk as indicated during the conduct of the C-SSRS with concurrence after a study physician's or PI evaluation if the response to C-SSRS questions 1 or 2 is "yes"

Where this trial is running

Aurora, Colorado

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Christian J Hopfer, MD — University of Colorado, Denver
• Study coordinator: Christian J Hopfer, MD

Conditions Cannabis Use Disorder