NCT06569394 A Study of Cannabidiol in Young Adult Cannabis Users
| NCT ID | NCT06569394 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Colorado, Denver |
| Condition | Cannabis Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-12-09 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2024-12-09 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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"
Contact & Investigator
Christian J Hopfer, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06569394 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 25 Years, studying Cannabis Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06569394 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06569394 currently recruiting?
Yes, NCT06569394 is actively recruiting participants. Contact the research team at christian.hopfer@cuanschutz.edu for enrollment information.
Where is the NCT06569394 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06569394 clinical trial?
NCT06569394 is sponsored by University of Colorado, Denver. The principal investigator is Christian J Hopfer, MD at University of Colorado, Denver. The trial plans to enroll 200 participants.