Effects of Cannabidiol on Stress and Nicotine Withdrawal

Launched by JOHNS HOPKINS UNIVERSITY · May 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how cannabidiol (CBD), a compound found in cannabis, affects stress and withdrawal symptoms in people who use nicotine, such as those who smoke cigarettes. The study aims to understand how CBD may help reduce stress and manage cravings during nicotine withdrawal, while also examining if there are any differences based on gender. Participants will be given CBD and asked to experience stress while researchers measure their responses. Some participants may need to stop smoking for 24 hours before each session to see how their bodies react.

To join the study, you need to be a healthy adult between 21 and 70 years old who has been smoking more than five cigarettes a day for at least two years. You should not be planning to quit smoking in the next month, and you should not have any serious health issues that could interfere with the study. Participants will be monitored throughout the study, and women who can become pregnant will need to use effective contraception. The study is not currently recruiting participants, but it aims to gather important information about CBD and its potential benefits for those dealing with nicotine dependence.

Gender

ALL

Eligibility criteria

• 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 \> 8 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.