A Randomized, Placebo Controlled Study of Cannabidiol in Young Adult Cannabis Users
- Conditions
- Cannabis Use Disorder
- Registration Number
- NCT06569394
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria:<br><br> 1. Ages 18-25<br><br> 2. Must have used cannabis flower or concentrates at least five days per week for the<br> past year.<br><br> 3. Currently not seeking to cut down or stop cannabis use<br><br> 4. At least two symptoms of a DSM-5 cannabis use disorder<br><br>Exclusion Criteria:<br><br> 1. Use of any illicit substance besides alcohol, nicotine, or cannabis (e.g., cocaine,<br> opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 60<br> days, as indicated by self-report and urine toxicology screening at the beginning of<br> each study visit.<br><br> 2. Alcohol use on 3 or more days per week, and/or >3 drinks per drinking day in the<br> past 60 days. Participants must also have a breath alcohol level of 0 at the<br> beginning of each study visit.<br><br> 3. Daily nicotine use.<br><br> 4. Meets DSM-5 diagnostic criteria for a psychotic disorder (e.g., schizophrenia,<br> schizophreniform disorder, schizoaffective disorder), bipolar disorder, major<br> depression with suicidal ideation, or a history of treatment for these disorders.<br><br> 5. Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe<br> asthma, chronic obstructive pulmonary disease)<br><br> 6. Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic<br> medication.<br><br> 7. Current use of anti-epileptic medications (e.g., clobazam, sodium valproate) or<br> medications known to have major interactions with Epidiolex (buprenorphine,<br> leflunomide, levomethadyl acetate, lomitapide, mipomersen, pexidartinib,<br> propoxyphene, sodium oxybate, and/or teriflunomide) or a history of seizures.<br><br> 8. Current use of strong or moderate CYP3A4 inhibitors or inducers (commonly used<br> examples not captured by other exclusion criteria include protease inhibitors,<br> macrolide antibiotics [e.g., erythromycin], azole antifungals [e.g., ketoconazole],<br> verapamil, and grapefruit juice).<br><br> 9. Current use of strong or moderate CYP2C19 inhibitors or inducers (commonly used<br> examples not captured by other exclusion criteria include proton pump inhibitors,<br> prednisone, and norethisterone).<br><br> 10. Current or past hepatocellular disease, as indicated by medical history or alanine<br> aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin greater<br> than two times the upper limit of the normal range at screening.<br><br> 11. For female participants, pregnancy or trying to become pregnant. A positive<br> pregnancy test at the beginning of any study visit will result in exclusion from<br> ongoing study participation.<br><br> 12. For female participants, currently lactating.<br><br> 13. For female patients of childbearing potential, not willing to use at least one<br> approved method of birth control while taking the study medication, unless she is<br> surgically sterile, partner is surgically sterile, or she is postmenopausal (one<br> year).<br><br> 14. Current suicidality risk as indicated during the conduct of the C-SSRS with<br> concurrence after a study physician's or PI evaluation if the response to C-SSRS<br> questions 1 or 2 is yes
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in blood THC-COOH levels;Difference in blood THC levels;Difference in cannabis use
- Secondary Outcome Measures
Name Time Method