RecruitingPhase 1

Effects of Cannabidiol on Stress and Nicotine Withdrawal

United States90 participantsStarted 2025-08-25

Plain-language summary

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.

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 \>= 5 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Negative Affect as assessed by the Subjective State Scale

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Positive Affect as assessed by the Subjective State Scale

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Blood Plasma Cortisol level

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Salivary Cortisol level

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Plasma Concentration of Endocannabinoids

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Heart Rate (beats per minutes)

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Trial details

NCT IDNCT07001930

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-09-01

Contact for this trial

Lauren Brogdon, MHS

410-550-6953 lmorri20@jhmi.edu

View on ClinicalTrials.gov More CBD trials

Plain-language summary

Who can participate

Age range

21 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 \>= 5 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.

Exclusion criteria

What they're measuring

Negative Affect as assessed by the Subjective State Scale

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Positive Affect as assessed by the Subjective State Scale

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Blood Plasma Cortisol level

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Salivary Cortisol level

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Plasma Concentration of Endocannabinoids

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints

Heart Rate (beats per minutes)

Timeframe: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints