Effects of cannabidiol on cannabis concentrate users

Cannabidiol and Cannabis Concentrate Users: A Randomized, Placebo Controlled Study

This study is testing if taking CBD can help regular cannabis concentrate users feel less cravings and use less of it over four weeks.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 25 Years to 60 Years
• Sex: All
• Sponsor: University of Colorado, Denver (other)
• Drugs / interventions: pexidartinib, prednisone
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT06575751 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effects of plant-derived cannabidiol (CBD) on individuals who regularly use cannabis concentrates but are not attempting to reduce their use. It is a randomized, placebo-controlled, dose-ranging study involving 120 adult participants who will take either 200 mg or 400 mg of CBD or a placebo daily for four weeks. Participants will engage in sessions at a mobile laboratory where their cannabis use, subjective effects, and cannabinoid levels will be monitored. The study aims to determine if CBD can reduce cannabis concentrate use and cravings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 25-60 who regularly use cannabis concentrates and are not seeking to cut down on their usage.

Not a fit: Patients who have recently used illicit substances or CBD products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic option for individuals struggling with cannabis use disorder.

How similar studies have performed: Other studies have explored CBD's effects on substance use, but this specific approach is novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Age 25-60.
2. Regular use (at least 4 times per week) of cannabis concentrates for the last year.
3. Not currently seeking to cut down or stop cannabis use.
4. At least one episode of 3 consecutive days of cannabis abstinence with no experience of severe withdrawal symptoms (i.e., \>=4 DSM-5 Cannabis Withdrawal symptoms rated as "severe"), in the last 90 days.
5. 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. Use of CBD-containing products other than cannabis concentrates in the past 90 days.
3. 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.
4. Daily nicotine use.
5. Meets DSM-5 diagnostic criteria for a psychotic disorder (e.g., schizophrenia, schizophreniform disorder, schizoaffective disorder), bipolar disorder, or major depression with suicidal ideation, or has a history of treatment for these disorders.
6. Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease, etc.)
7. Current use of any psychotropic (e.g., antidepressants, anxiogenics) or hepatotoxic medications.
8. Currently 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.
9. 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).
10. 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).
11. Current or past hepatocellular disease, as indicated by medical history or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of the normal range at screening.
12. 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.
13. For female participants, currently lactating.
14. For female patients of childbearing potential, not willing to use at least an 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).
15. 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: Joseph P Schacht, PhD — University of Colorado, Denver
• Study coordinator: Joseph P Schacht, PhD

Conditions: Cannabis Use Disorder