RECRUITING

Oral Cannabidiol for Tobacco Cessation

Conditions

Tobacco Use Tobacco Smoking Tobacco Dependence Tobacco Use Disorder Tobacco Use Cessation Tobacco Smoking Cannabidiol CBD

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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

Cannabidiol is a compound found in cannabis plants that is well tolerated, has low abuse liability, and might be an effective medication to promote tobacco cessation. This clinical study will use a validated approach for screening tobacco cessation medications to determine if oral cannabidiol increases short-term tobacco abstinence, and evaluate mechanisms that might explain how cannabidiol alters smoking behavior. Results from this study will provide data on the therapeutic potential of cannabidiol for tobacco cessation.

Official Title

Oral Cannabidiol for Tobacco Cessation

Quick Facts

Study Start:2022-11-01

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05445804

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:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Have provided written informed consent 2. Be between the ages of 18 and 65 3. Report use of \> 10 cigarettes per day for \> 1 year with smoking status verified by either a positive breath carbon monoxide test (\>8ppm) or urine cotinine test (\>200ng/mL) at screening 4. Report interest in quitting tobacco in the next two months 5. Are willing to engage in a series of practice quit attempts as part of the study. 6. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests as determined by a licensed medical professional. 7. 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. Acceptable forms of contraception include: double barrier contraception or a combination of a barrier contraception and a hormonal implant, injectable, combined oral contraceptive, or a male partner who has had a vasectomy; intrauterine device or tubal ligation.	1. Meet Diagnostic and Statistical Manual-V criteria for substance use disorders except for nicotine or tobacco use disorders 2. Are currently receiving or interested in immediately receiving behavioral treatment or medication for smoking cessation 3. Test positive for drugs of abuse (except nicotine) and/or breath alcohol test at study admission 4. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity. 5. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) 6. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding. 7. Use of an over the counter, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the participant 8. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes. 9. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina). 10. Have elevated serum liver transaminase (AST or ALT) above 2 x upper limit of normal, or elevated bilirubin above 1.5 x upper limit of normal. 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. Have provided written informed consent
2. Be between the ages of 18 and 65
3. Report use of \> 10 cigarettes per day for \> 1 year with smoking status verified by either a positive breath carbon monoxide test (\>8ppm) or urine cotinine test (\>200ng/mL) at screening
4. Report interest in quitting tobacco in the next two months
5. Are willing to engage in a series of practice quit attempts as part of the study.
6. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests as determined by a licensed medical professional.
7. 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. Acceptable forms of contraception include: double barrier contraception or a combination of a barrier contraception and a hormonal implant, injectable, combined oral contraceptive, or a male partner who has had a vasectomy; intrauterine device or tubal ligation.

1. Meet Diagnostic and Statistical Manual-V criteria for substance use disorders except for nicotine or tobacco use disorders
2. Are currently receiving or interested in immediately receiving behavioral treatment or medication for smoking cessation
3. Test positive for drugs of abuse (except nicotine) and/or breath alcohol test at study admission
4. Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity.
5. Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
6. Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding.
7. Use of an over the counter, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study results or the safety of the participant
8. Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or sponsor, will interfere with the study result or the safety of the participant. This includes any medication metabolized via CYP2D6, CYP2C9, CYP2B10, or which induce/inhibit CYP3A4 enzymes.
9. Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina).
10. Have elevated serum liver transaminase (AST or ALT) above 2 x upper limit of normal, or elevated bilirubin above 1.5 x upper limit of normal.
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

Dustin C Lee, PhD

CONTACT

410-550-4035

dlee214@jhmi.edu

Principal Investigator

Dustin C Lee, PhD

PRINCIPAL_INVESTIGATOR

Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center

Study Locations (Sites)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Dustin C Lee, PhD, PRINCIPAL_INVESTIGATOR, Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center

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 Date2022-11-01

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

Tobacco
Smoking
Cannabidiol
CBD

Additional Relevant MeSH Terms

Tobacco Use
Tobacco Smoking
Tobacco Dependence
Tobacco Use Disorder
Tobacco Use Cessation