Actively Recruiting
Oral Cannabidiol for Tobacco Cessation to Evaluate Short-Term Tobacco Abstinence and Smoking Behavior
Led by Johns Hopkins University · Updated on 2026-01-07
50
Participants Needed
1
Research Sites
8 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
Researchers are evaluating oral cannabidiol (CBD), a compound found in cannabis plants, as a potential medication to help people stop smoking tobacco. This study focuses on adults who smoke more than 10 cigarettes a day and are interested in quitting. It aims to see if CBD increases short-term tobacco abstinence and to understand how it may affect smoking behavior and withdrawal symptoms. The research is sponsored by Johns Hopkins University and uses a careful method to test CBD's effects. Participants will receive oral doses of CBD twice daily at two different levels, 300 mg and 600 mg, and a matched placebo in a controlled, double-blind, crossover design. Each participant will receive all treatments in a different order to compare the effects within the same person. The study measures include biochemical verification of tobacco abstinence and other assessments related to tobacco withdrawal, craving, mood, and smoking behavior over several weeks. Throughout the study, participants will be monitored through tests such as breath carbon monoxide to confirm smoking abstinence, questionnaires on withdrawal symptoms and mood, and assessments of smoking patterns. The study tracks outcomes during simulated quit attempts at specific weeks and includes safety evaluations. Participation involves multiple visits for dosing and assessments over the study period ending in early 2027.
CONDITIONS
Brief Title
Oral Cannabidiol for Tobacco Cessation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Aged between 18 and 65 years
- Smoke more than 10 cigarettes per day for over 1 year, confirmed by breath carbon monoxide (>8 ppm) or urine cotinine (>200 ng/mL)
- Interested in quitting tobacco within the next two months
- Willing to participate in practice quit attempts during the study
- In good general health based on physical exam, medical history, vital signs, and screening tests
- For women of childbearing potential and men with partners of childbearing potential, willing to use effective contraception during the study and for at least 30 days after last study drug dose
You will not qualify if you...
- Have substance use disorders other than nicotine or tobacco use disorders
- Currently receiving or planning immediate behavioral or medication treatment for smoking cessation
- Test positive for drugs of abuse (except nicotine) or alcohol at study admission
- Have physical or mental illnesses that may affect safety or study integrity
- History or current suicidal behavior or ideation
- Pregnant, planning pregnancy within three months, or breastfeeding
- Use interfering medications, supplements, or vitamins within 14 days before study sessions
- Use prescription medications (except birth control) that may interfere within 14 days before study sessions
- History of significant cardiac arrhythmias or vasospastic disease
- Elevated liver enzymes above specified limits
- Enrolled in another clinical trial or received investigational drugs within 30 days before participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive oral cannabidiol or placebo in a double-blind, crossover design to evaluate short-term tobacco abstinence and smoking behavior.
Visits at weeks 2, 4, and 6 during treatment
Trial Site Locations
Total: 1 location
1
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
D
Dustin C Lee, PhD
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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