Recruiting
Phase 1

Cannabidiol

Sponsor:

Johns Hopkins University

Code:

NCT07001930

Conditions

CBD

Stress

Nicotine Dependence

Tobacco Smoking

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Epidiolex

Study Details

Brief 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.

Conditions

CBD

Stress

Nicotine Dependence

Tobacco Smoking

Study ID

NCT07001930

Start date

Aug 25, 2025

Status verified date

Aug, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Ad Lib (first)

Participants who use tobacco cigarettes and will be randomly assigned to smoking ab lib. Each participant will receive 0, 200, 400 mg of CBD in this arm.

experimental: Abstinence (first)

Participants who use tobacco cigarettes and will be randomly assigned to smoking abstinence for 24 hours before each session. Each participant will receive 0, 200, 400 mg of CBD in this arm.

Interventions

Epidiolex

Oral cannabidiol

Primary outcome measure

  • Negative Affect as assessed by the Subjective State Scale [ Time Frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints ]
  • Positive Affect as assessed by the Subjective State Scale [ Time Frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints ]
  • Blood Plasma Cortisol level [ Time Frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints ]
  • Salivary Cortisol level [ Time Frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints ]
  • Plasma Concentration of Endocannabinoids [ Time Frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints ]
  • Heart Rate (beats per minutes) [ Time Frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints ]
  • Systolic Blood Pressure (mmHg) [ Time Frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints ]
  • Diastolic Blood Pressure (mmHg) [ Time Frame: 20 minutes, 70 minutes, 120 minutes, 170 minutes, 190 minutes, 200 minutes, 220 minutes timepoints ]

Central Contacts and Locations

Central contacts

Locations

Behavioral Pharmacology Research Unit

Recruiting

Baltimore, Maryland, United States, 21224

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • CBD
  • Stress
  • Nicotine
  • Tobacco Smoking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-10.