Cannabidiol (CBD) for reducing stress and nicotine withdrawal in daily cigarette smokers.

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 is a double-blind, placebo-controlled, within-subject crossover trial in which each participant receives three acute oral doses of CBD (0 mg, 200 mg, 400 mg) across separate laboratory visits. Ninety adult daily cigarette smokers will complete three 5-hour lab sessions at least 72 hours apart, with biological and subjective measures collected before and after two challenges: an established psychological stress induction and a 24-hour nicotine abstinence challenge. Participants are randomized, stratified by sex and other tobacco-product use, to either continue nicotine ad libitum or abstain for 24 hours before sessions. The protocol includes one in-person medical screening and three pre-lab phone checks; total participation time for completers is about 2–3 weeks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy non-treatment seeking adults aged 21-70 (inclusive).
2. Use of \> 5 cigarettes per day for \> 2 years. (Use of other tobacco/nicotine products in addition to cigarettes will be acceptable).
3. Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level \>= 5 ppm.
4. Alcohol Use: \< 2 drinks/day on average (\< 14 drinks/week).
5. Sleep schedule: No graveyard or third shift work (i.e., participants must report a normal nighttime sleep schedule).
6. 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.

Exclusion Criteria:

1. Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
2. Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
3. Test positive for illicit drugs other than cannabis
4. Positive breath alcohol test (\>.01 g/210L) at study admission
5. Have a current physical or mental illness or takes a medication judged by the study team to negatively impact participant safety or scientific integrity
6. Have a resting heart rate \>100, systolic blood pressure \>160mmHg or \<100mmHg, or diastolic blood pressure \>100mmHg or \<50mmHg at screening.
7. Have cold intolerance or a medical condition that might be exacerbated by exposure to cold (e.g. Reynaud's, peripheral neuropathy, trigeminal neuralgia, poorly controlled/uncontrolled hypothyroidism).
8. Are currently pregnant, planning to become pregnant in the next three months, or are currently breastfeeding
9. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina, Raynaud's).
10. Have a history of and/or current liver disease, or elevated serum liver transaminase (AST or ALT) above 3 x Upper Limit of Normal (ULN), or elevated bilirubin above 2 x ULN at screening.
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.

Where it's running

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

Study contacts

• Principal investigator: Dustin C. Lee, PhD — Johns Hopkins University
• Study coordinator: Lauren Brogdon, MHS
• Email: lmorri20@jhmi.edu
• Phone: 410-550-6953

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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.