Oral Cannabidiol for Tobacco Cessation

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Tobacco Use, Tobacco Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation

In brief

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.

Key facts

Study ID

NCT05445804

Run by

Johns Hopkins University

People needed

50

Starts

2022-11-01

Expected to finish

2027-02-01

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have provided written informed consent
• Be between the ages of 18 and 65
• 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
• Report interest in quitting tobacco in the next two months
• Are willing to engage in a series of practice quit attempts as part of the study.
• 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.
• 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.

You may not qualify if…

• Meet Diagnostic and Statistical Manual-V criteria for substance use disorders except for nicotine or tobacco use disorders
• Are currently receiving or interested in immediately receiving behavioral treatment or medication for smoking cessation
• Test positive for drugs of abuse (except nicotine) and/or breath alcohol test at study admission
• Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity.
• 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)
• Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding.
• 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
• 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.
• Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina).
• 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.
• Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

Where it is running

• Johns Hopkins Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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