Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT05445804

Oral Cannabidiol for Tobacco Cessation

Led by Johns Hopkins University · Updated on 2026-01-07

50

Participants Needed

1

Research Sites

221 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Oral Cannabidiol for Tobacco Cessation

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Have provided written informed consent
  • Be between the ages of 18 and 65
  • Report use of more than 10 cigarettes per day for over 1 year with smoking status verified by 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 physical exam, medical history, vital signs, and screening urine and blood tests
  • For women of childbearing potential and men with female partners of childbearing potential, be willing to use effective contraception during the study and for at least 30 days after last study drug dose
Not Eligible

You will not qualify if you...

  • Meet criteria for substance use disorders other than nicotine or tobacco use disorders
  • Currently receiving or interested in immediate behavioral treatment or medication for smoking cessation
  • Test positive for drugs of abuse (except nicotine) or breath alcohol at study admission
  • Have a current physical or mental illness that may affect safety or study integrity
  • Have a history of suicidal behavior or current suicidal ideation
  • Are currently pregnant, planning pregnancy in next three months, or breastfeeding
  • Use over-the-counter, systemic or topical drugs, herbal supplements, or vitamins within 14 days before sessions that may interfere with study results or safety
  • Use prescription medications (except birth control) within 14 days before sessions that may interfere with study or safety, including certain enzyme-metabolized drugs
  • Have history of significant cardiac arrhythmias or vasospastic disease
  • Have elevated liver enzymes (AST or ALT) above 2 times normal or bilirubin above 1.5 times normal
  • Currently enrolled in another clinical trial or received any research drug within 30 days of participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States, 21224

Actively Recruiting

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Research Team

D

Dustin C Lee, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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