Status:
RECRUITING
A Study of Cannabidiol in Young Adult Cannabis Users
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Use Disorder
Eligibility:
All Genders
18-25 years
Phase:
PHASE2
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 administ...
Detailed Description
Emerging adults have the highest prevalence of cannabis use and CUD of any age group. Despite high rates of use and CUD, treatment seeking is relatively uncommon among emerging adults. Those who use c...
Eligibility Criteria
Inclusion
- Ages 18-25
- Must have used cannabis flower or concentrates at least five days per week for the past year.
- Currently not seeking to cut down or stop cannabis use
- At least two symptoms of a DSM-5 cannabis use disorder
Exclusion
- 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.
- 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.
- Daily nicotine use.
- 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.
- Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease)
- Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medication.
- 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.
- 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).
- 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).
- 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.
- 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.
- For female participants, currently lactating.
- 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).
- 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"
Key Trial Info
Start Date :
December 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06569394
Start Date
December 9 2024
End Date
June 30 2028
Last Update
February 7 2025
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045