Treatment for Cannabis Use Disorder with Cannabidiol

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC) in reducing cannabis use and symptoms of cannabis use disorder (CUD) in adults who regularly use cannabis concentrates. Participants will be randomly assigned to receive either full spectrum CBD, broad spectrum CBD, or a placebo over an 8-week period, with additional psychotherapy treatment for CUD. The study includes telehealth follow-ups and assessments of drug exposure and various psychological and physical health measures. This research aims to address the lack of effective treatments for individuals with high potency cannabis use.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Regular use (at least 4 times per week) of cannabis concentrates for at least the last year.
* Meets DSM5 criteria for at least moderate CUD.
* Currently seeking to cut down or stop cannabis use.

Exclusion Criteria:

* Use of any substance of abuse besides alcohol, nicotine, or cannabis (e.g., cocaine, non-prescription use of opiates, methamphetamine, MDMA, benzodiazepines, or barbiturates) in the past 90 days, as indicated by self-report and urine toxicology screening (Syva Rapid Test) at baseline.
* Use of CBD-dominant products in the past 90 days, as evidenced by self-report of use of a CBD\>THC product or CBD blood levels at baseline of \>= 5 ng/mL
* Alcohol use on 3 or more days per week, and/or \> 3 drinks per drinking day in the past 90 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, or major depression with suicidal ideation, or has a history of treatment for these disorders. Psychiatric disorders will be assessed with the Mini-International Neuropsychiatric Interview (MINI).
* Current cardiovascular or respiratory disease (e.g., coronary artery disease, severe asthma, chronic obstructive pulmonary disease, etc.)
* Current use of psychotropics (e.g., antidepressants, anxiogenics), which may dampen effects of CBD.
* 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).
* Current or past hepatocellular disease, as indicated by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times the upper limit of the normal range at screening or a history of liver disease irrespective of AST and ALT at the time of screening.
* For participants assigned female at birth, pregnancy or trying to become pregnant as indicated by a urine pregnancy test administered at the beginning of each study visit.
* History of seizures
* Current use of potent CYP2C19 or CYP3A4 inducers (e.g., Rifampin, apalutamide, carbamazepine, enzalutamide, ivosidenib9, lumacaftor, ivacaftor, phenytoin, St. John's wort, Fosphenytoin, Mitotane, Phenobarbital, Primidone), or strong CYP3A inhibitors (e.g., clarithromycin, HIV protease inhibitors, and most antifungals), 2C19 inhibitors (e.g., fluoxetine, Lansoprazole, Tricyclic antidepressants (TCAs))
* Allergy to study medications (hemp seed oil, hemp extract, gelatin, glycerin)

Where it's running

• University of Colorado Boulder
  Boulder, Colorado, United States Recruiting

Study contacts

• Study coordinator: Jonathan Lisano, PhD
• Email: Jonathon.Lisano@colorado.edu
• Phone: 303-492-9549

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can tACS modulate motivation and reward signals in cannabis use disorder and depression

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• Sex differences in how cannabis affects people who regularly use it

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  Recruiting Phase 2 Medical University of South Carolina · Charleston, South Carolina · NCT07815691

• Semaglutide for cannabis use disorder: see if a medicine helps reduce use

  This study tests whether weekly injections of semaglutide can help adults with cannabis use disorder reduce their cannabis use compared with placebo.

  Recruiting Phase 2 Psychiatric Centre Rigshospitalet · Frederiksberg · NCT07523633

• Brain imaging to predict teens' response to cannabis treatment

  This project will test whether teens' brain activity during a learning task can predict how well 14–17-year-olds do in a 10-week virtual reward program to reduce cannabis use.

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• Reducing cannabis use to improve daily functioning.

  This program will try an 8-week combination of motivational interviewing, computerized CBT (CBT4CBT), and small financial rewards to help adults with cannabis use disorder cut back on cannabis.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT07218471

• Home-based brain stimulation with guided mindfulness for cannabis use disorder

  This project tests whether daily at-home mild brain stimulation plus guided mindfulness can help adults with cannabis use disorder reduce or stop their cannabis use.

  Recruiting NYU Langone Health · New York, New York · NCT07184983

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.