A Study of Cannabidiol in Young Adult Cannabis Users

Launched by UNIVERSITY OF COLORADO, DENVER · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of cannabidiol (CBD), a compound derived from hemp, on young adults who regularly use cannabis and may have cannabis use disorder. The researchers want to see if taking CBD can help reduce any harmful effects associated with heavy cannabis use. Participants in this study will be young adults aged 18 to 25 who have been using cannabis flower or concentrates at least five days a week for the past year and are not currently looking to cut back on their use. Half of the participants will receive CBD, while the other half will receive a placebo (a non-active substance).

To be eligible, participants must meet certain criteria, such as using cannabis regularly and showing some signs of cannabis use disorder, but they should not be using other illicit drugs or have certain medical conditions. Throughout the study, participants will take part in a mobile lab setting, where their usual cannabis consumption will be observed. This unique approach allows researchers to better understand the real-life effects of cannabis use while also assessing the potential benefits of CBD. If you or someone you know fits the eligibility criteria and is interested in participating, this could be an important opportunity to contribute to research in this area.

Gender

ALL

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"