NCT05445804 Oral Cannabidiol for Tobacco Cessation
| NCT ID | NCT05445804 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Tobacco Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2022-11-01 with a primary completion date of 2026-12-01.
⚠ 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
Cannabidiol is a compound found in cannabis plants that is well tolerated, has low abuse liability, and might be an effective medication to promote tobacco cessation. This clinical study will use a validated approach for screening tobacco cessation medications to determine if oral cannabidiol increases short-term tobacco abstinence, and evaluate mechanisms that might explain how cannabidiol alters smoking behavior. Results from this study will provide data on the therapeutic potential of cannabidiol for tobacco cessation.
Eligibility Criteria
Inclusion Criteria: 1. Have provided written informed consent 2. Be between the ages of 18 and 65 3. Report use of \> 10 cigarettes per day for \> 1 year with smoking status verified by either a positive breath carbon monoxide test (\>8ppm) or urine cotinine test (\>200ng/mL) at screening 4. Report interest in quitting tobacco in the next two months 5. Are willing to engage in a series of practice quit attempts as part of the study. 6. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests as determined by a licensed medical professional. 7. For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last study drug administration. Acceptable forms of contraception include: double barrier contraception or a combination of a barrier contraception and a hormonal implant, injectable, combined oral contraceptive, or a male partner who has had a vasectomy; intrauterine device or tubal ligation. Exclusion Criteria: 1. Meet Diagnostic and Statistical Manual-V criteria for substance use disorders except for nicotine or tobacco use disorders 2. Are currently receiving or interested in immediately receiving behavioral treatment or medication for smoking cessation 3. Test positive for drugs of abuse (except nicotine) and/or breath alcohol test at study admission 4. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity. 5. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) 6. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding. 7. Use of an over the counter, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the participant 8. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes. 9. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina). 10. Have elevated serum liver transaminase (AST or ALT) above 2 x upper limit of normal, or elevated bilirubin above 1.5 x upper limit of normal. 11. Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation. \-
Contact & Investigator
Dustin C Lee, PhD
PRINCIPAL INVESTIGATOR
Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center
Frequently Asked Questions
Who can join the NCT05445804 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Tobacco Use. 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 NCT05445804 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05445804 currently recruiting?
Yes, NCT05445804 is actively recruiting participants. Contact the research team at dlee214@jhmi.edu for enrollment information.
Where is the NCT05445804 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT05445804 clinical trial?
NCT05445804 is sponsored by Johns Hopkins University. The principal investigator is Dustin C Lee, PhD at Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center. The trial plans to enroll 50 participants.