Oral Cannabidiol for Tobacco Cessation

NCT05445804 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00170600R21DA045744
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Tobacco; Smoking; Cannabidiol; CBD

Outcome Measures

Primary Outcomes (1)

• biochemically-verified tobacco abstinence as assessed by expired carbon monoxide

  Biochemically-verified tobacco abstinence as assessed by expired carbon monoxide part per million during the 4-day practice quit attempt of each drug condition.

  4 days

Secondary Outcomes (8)

• Smoking Puff Topography

  Change between simulated quit attempt (weeks 2, 4, and 6).

• Cigarette Purchase Task

  Change between simulated quit attempt (weeks 2, 4, and 6).

• Modified Cigarette Evaluation Scale

  Change between simulated quit attempt (weeks 2, 4, and 6).

• Tobacco Smoking as assessed by self report

  Change between simulated quit attempt (weeks 2, 4, and 6).

• Tobacco Withdrawal as assessed by the Minnesota Nicotine Withdrawal Scale

  2 weeks

Study Arms (2)

Within-Subjects Dose Conditions

EXPERIMENTAL

All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants. Thus, comparisons of the drug conditions on outcome measures will be compared within-subjects (e.g., between drug and placebo) and not between arms.

Drug: 300 mg Cannabidiol; Drug: 600 mg Cannabidiol; Drug: Placebo

Additional Within-Subjects Dose Conditions

EXPERIMENTAL

All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants. Thus, comparisons of the drug conditions on outcome measures will be compared within-subjects (e.g., between drug and placebo) and not between arms.

Drug: 300 mg Cannabidiol; Drug: 600 mg Cannabidiol; Drug: Placebo

Interventions

300 mg Cannabidiol DRUG

300 mg CBD in Medium Chain Triglyceride oil b.i.d.

Additional Within-Subjects Dose Conditions; Within-Subjects Dose Conditions

600 mg Cannabidiol DRUG

600 mg CBD in Medium Chain Triglyceride oil b.i.d.

Additional Within-Subjects Dose Conditions; Within-Subjects Dose Conditions

Placebo DRUG

Medium Chain Triglyceride oil

Additional Within-Subjects Dose Conditions; Within-Subjects Dose Conditions

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have provided written informed consent
• Be between the ages of 18 and 65
• 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
• Report interest in quitting tobacco in the next two months
• Are willing to engage in a series of practice quit attempts as part of the study.
• 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.
• 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.

You may not qualify if:

• Meet Diagnostic and Statistical Manual-V criteria for substance use disorders except for nicotine or tobacco use disorders
• Are currently receiving or interested in immediately receiving behavioral treatment or medication for smoking cessation
• Test positive for drugs of abuse (except nicotine) and/or breath alcohol test at study admission
• Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity.
• 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)
• Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding.
• 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
• 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.
• Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina).
• 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.
• Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use; Tobacco Smoking; Tobacco Use Disorder; Tobacco Use Cessation; Smoking

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Dustin C Lee, PhD

  Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dustin C Lee, PhD

CONTACT

410-550-4035; dlee214@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants.

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 6, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)