Using Cannabidiol to Help People Quit Smoking

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 clinical trial investigates the effectiveness of oral cannabidiol (CBD) as a potential treatment for tobacco cessation. Participants who smoke more than 10 cigarettes a day will receive either 300 mg or 600 mg of CBD, or a placebo, to assess its impact on short-term tobacco abstinence. The study aims to understand how CBD may alter smoking behavior and alleviate withdrawal symptoms. By employing a validated screening approach, the research seeks to provide insights into the therapeutic potential of CBD for individuals struggling with tobacco dependence.

Why it matters

Who can join: the full rules

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.

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Where it's running

• Johns Hopkins Behavioral Pharmacology Research Unit
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Dustin C Lee, PhD — Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center
• Study coordinator: Dustin C Lee, PhD
• Email: dlee214@jhmi.edu
• Phone: 410-550-4035

Similar studies

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

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• Using cannabidiol to help reduce cigarette smoking

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• Abuse potential of five modern oral nicotine products

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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.