Effects of Cannabidiol on Stress and Nicotine Withdrawal
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: CBD, Stress, Nicotine Dependence, Tobacco Smoking
In brief
The purpose of this study is to examine the effect of doses of cannabidiol (CBD) during exposure to stress and nicotine withdrawal in nicotine users. The main objectives of the study include examining the effect CBD has on stress, tobacco dependence, tobacco withdrawal, and sex differences between these types of stress. Participants will be administered CBD and exposed to stress. Biological and subjective measures will be collected. Participants may be asked to stop use for 24 hours. Researchers will also investigate withdrawal effects between participants who have not smoked nicotine in 24 hours and those who have continued to smoke before each session.
Key facts
- Study ID
- NCT07001930
- Run by
- Johns Hopkins University
- People needed
- 90
- Starts
- 2025-08-25
- Expected to finish
- 2029-09-01
- Last updated by the study team
- 2025-09-02
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Healthy non-treatment seeking adults aged 21-70 (inclusive).
- Use of > 5 cigarettes per day for > 2 years. (Use of other tobacco/nicotine products in addition to cigarettes will be acceptable).
- Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level > 8 ppm.
- Alcohol Use: < 2 drinks/day on average (< 14 drinks/week).
- Sleep schedule: No graveyard or third shift work (i.e., participants must report a normal nighttime sleep schedule).
- 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.
You may not qualify if…
- Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
- Test positive for illicit drugs other than cannabis
- Positive breath alcohol test (>.01 g/210L) at study admission
- Have a current physical or mental illness or takes a medication judged by the study team to negatively impact participant safety or scientific integrity
- Have a resting heart rate >100, systolic blood pressure >160mmHg or <100mmHg, or diastolic blood pressure >100mmHg or <50mmHg at screening.
- 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).
- Are currently pregnant, planning to become pregnant in the next three months, or are currently breastfeeding
- Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina, Raynaud's).
- 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.
- 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 is running
- Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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