RECRUITING

Effects of Cannabidiol on Stress and Nicotine Withdrawal

Conditions

CBD Stress Nicotine Dependence Tobacco Smoking Nicotine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pharmacological Effects of Cannabidiol on Responses to Stress and Nicotine Withdrawal

Quick Facts

Study Start:2025-08-25

Study Completion:2029-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07001930

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Lauren Brogdon, MHS

CONTACT

410-550-6953

lmorri20@jhmi.edu

Dustin C. Lee, PhD

CONTACT

410-550-4035

dlee@jhmi.edu

Principal Investigator

Dustin C. Lee, PhD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Dustin C. Lee, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-25

Study Completion Date2029-09-01

Study Record Updates

Study Start Date2025-08-25

Study Completion Date2029-09-01

Terms related to this study

Keywords Provided by Researchers

CBD
Stress
Nicotine
Tobacco Smoking

Additional Relevant MeSH Terms

CBD
Stress
Nicotine Dependence
Tobacco Smoking