Tobacco UsePhase 1NCT05445804
Oral Cannabidiol for Tobacco Cessation
A Phase 1 study testing 300 mg Cannabidiol and 600 mg Cannabidiol in people with Tobacco Use and Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Tobacco Smoking, Tobacco Dependence
- What is being tested?
- 300 mg Cannabidiol and 600 mg Cannabidiol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
Dustin C Lee, PhD, 410-550-4035, dlee214@jhmi.edu
About this study
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.
Read the detailed description
Although tobacco smoking rates continue to decrease, cigarette smoking remains the leading cause of preventable disease and death in the United States and few tobacco users achieve sustained abstinence, underscoring the need for alternative treatments. The endocannabinoid system can modulate the reinforcing effects of nicotine and may be a target for development of pharmacotherapies for tobacco cessation. The cannabinoid type 1 receptor receptor inverse agonist/antagonist rimonabant has demonstrated efficacy in increasing tobacco abstinence rates in clinical trials, though it was abandoned as a viable medication due to adverse psychiatric side effects. Compounds that have similar pharmacology to rimonabant, but without the adverse psychiatric side effect profile may be efficacious for tobacco cessation. Cannabidiol (CBD) is a naturally occurring constituent of the cannabis plant that has been well tolerated in clinical studies and has low abuse liability. CBD has demonstrated anxiolytic, antipsychotic, and antidepressant effects, and can reduce appetite, suggesting that it may reduce known nicotine withdrawal symptoms associated with relapse. One clinical study provided initial evidence that CBD may be useful to promote tobacco cessation, however, the mechanism by which smoking was reduced is not clear and appropriate dosing remains unknown.
This research will apply a rigorous methodological approach as an early screener for potential pharmacotherapies for tobacco dependence. This approach will utilize systematic dose administration and biochemical verification of smoking abstinence to evaluate CBD as a potential pharmacotherapy for tobacco cessation. A double-blind, within-subject, double-crossover design will be used to compare the effect of twice-daily oral CBD and matched placebo on short-term tobacco abstinence, and explore potential mechanisms underlying the effect of CBD on tobacco withdrawal, negative affect, and reinforcement.
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation
- Being tested
- 300 mg Cannabidiol, 600 mg Cannabidiol, Placebo
- Keywords
- Tobacco, Smoking, Cannabidiol, CBD
- Medical subject headings
- Tobacco Use, Tobacco Smoking, Tobacco Use Disorder, Tobacco Use Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 mg CannabidiolDrug
300 mg CBD in Medium Chain Triglyceride oil b.i.d.
600 mg CannabidiolDrug
600 mg CBD in Medium Chain Triglyceride oil b.i.d.
PlaceboDrug
Medium Chain Triglyceride oil
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 300 mg Cannabidiol; Drug: 600 mg Cannabidiol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 days
Secondary outcomes (8)
Smoking Puff Topography
smoking puff topography will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Measured: Change between simulated quit attempt (weeks 2, 4, and 6).
Cigarette Purchase Task
Cigarette Purchase Task will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Measured: Change between simulated quit attempt (weeks 2, 4, and 6).
Modified Cigarette Evaluation Scale
Modified Cigarette Evaluation Scale will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).
Measured: Change between simulated quit attempt (weeks 2, 4, and 6).
Tobacco Smoking as assessed by self report
Self-reported cigarettes per day
Measured: Change between simulated quit attempt (weeks 2, 4, and 6).
Tobacco Withdrawal as assessed by the Minnesota Nicotine Withdrawal Scale
Minnesota Nicotine Withdrawal Scale Total Score (range 0 - 36) higher scores equate with greater withdrawal
Measured: 2 weeks
Tobacco Withdrawal as assessed by the Questionnaire of Smoking Urges - Brief
Questionnaire of Smoking Urges - Brief - Ten item questionnaire contains two 5-item factor scores - higher scores equate with greater smoking urge
Measured: 2 weeks
Tobacco Withdrawal as assessed by the Positive and Negative Affect Scale
Positive and Negative Affect Scale - composed of 20 items, 10 measuring positive affect and 10 measuring negative affect. Scores range from 1 to 5 corresponding with extent to which the affect was experienced in the specified timeframe.
Measured: 2 weeks
Tobacco Withdrawal as assessed by the Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale - 14 item assessment of anxiety and depression. Each item measured on a 4-point scale. Higher scores equate with greater depression/anxiety.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Nov 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Dustin C Lee, PhD, Principal investigator, Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445804
- Sponsor's protocol ID
- IRB00170600
- Other IDs
- R21DA045744
- Status last verified
- Jan 2026
- First submitted
- 30 Jun 2022
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not currently a plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Cannabidiol for Tobacco Cessation
- ClinicalTrials.gov ID
- NCT05445804
- Acronym / sponsor ID
- IRB00170600
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Dependence, Tobacco Use Disorder, Tobacco Use Cessation
- Keywords
- Tobacco, Smoking, Cannabidiol, CBD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although tobacco smoking rates continue to decrease, cigarette smoking remains the leading cause of preventable disease and death in the United States and few tobacco users achieve sustained abstinence, underscoring the need for alternative treatments. The endocannabinoid system can modulate the reinforcing effects of nicotine and may be a target for development of pharmacotherapies for tobacco cessation. The cannabinoid type 1 receptor receptor inverse agonist/antagonist rimonabant has demonstrated efficacy in increasing tobacco abstinence rates in clinical trials, though it was abandoned as a viable medication due to adverse psychiatric side effects. Compounds that have similar pharmacology to rimonabant, but without the adverse psychiatric side effect profile may be efficacious for tobacco cessation. Cannabidiol (CBD) is a naturally occurring constituent of the cannabis plant that has been well tolerated in clinical studies and has low abuse liability. CBD has demonstrated anxiolytic, antipsychotic, and antidepressant effects, and can reduce appetite, suggesting that it may reduce known nicotine withdrawal symptoms associated with relapse. One clinical study provided initial evidence that CBD may be useful to promote tobacco cessation, however, the mechanism by which smoking was reduced is not clear and appropriate dosing remains unknown.
This research will apply a rigorous methodological approach as an early screener for potential pharmacotherapies for tobacco dependence. This approach will utilize systematic dose administration and biochemical verification of smoking abstinence to evaluate CBD as a potential pharmacotherapy for tobacco cessation. A double-blind, within-subject, double-crossover design will be used to compare the effect of twice-daily oral CBD and matched placebo on short-term tobacco abstinence, and explore potential mechanisms underlying the effect of CBD on tobacco withdrawal, negative affect, and reinforcement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants.
| Arm | Type | Receives |
|---|---|---|
| Within-Subjects Dose Conditions | Experimental | Drug: 300 mg Cannabidiol, Drug: 600 mg Cannabidiol, Drug: PlaceboAll 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. |
| Additional Within-Subjects Dose Conditions | Experimental | Drug: 300 mg Cannabidiol, Drug: 600 mg Cannabidiol, Drug: PlaceboAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 300 mg Cannabidiol300 mg CBD in Medium Chain Triglyceride oil b.i.d. | Drug | Additional Within-Subjects Dose Conditions, Within-Subjects Dose Conditions |
| 600 mg Cannabidiol600 mg CBD in Medium Chain Triglyceride oil b.i.d. | Drug | Additional Within-Subjects Dose Conditions, Within-Subjects Dose Conditions |
| PlaceboMedium Chain Triglyceride oil | Drug | Additional Within-Subjects Dose Conditions, Within-Subjects Dose Conditions |
Primary outcome
biochemically-verified tobacco abstinence as assessed by expired carbon monoxide
Time frame: 4 days
Biochemically-verified tobacco abstinence as assessed by expired carbon monoxide part per million during the 4-day practice quit attempt of each drug condition.
8 secondary outcomes
Smoking Puff Topography
Time frame: Change between simulated quit attempt (weeks 2, 4, and 6).
Cigarette Purchase Task
Time frame: Change between simulated quit attempt (weeks 2, 4, and 6).
Modified Cigarette Evaluation Scale
Time frame: Change between simulated quit attempt (weeks 2, 4, and 6).
Tobacco Smoking as assessed by self report
Time frame: Change between simulated quit attempt (weeks 2, 4, and 6).
Tobacco Withdrawal as assessed by the Minnesota Nicotine Withdrawal Scale
Time frame: 2 weeks
Tobacco Withdrawal as assessed by the Questionnaire of Smoking Urges - Brief
Time frame: 2 weeks
Tobacco Withdrawal as assessed by the Positive and Negative Affect Scale
Time frame: 2 weeks
Tobacco Withdrawal as assessed by the Hospital Anxiety and Depression Scale
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No. There is not currently a plan to make individual participant data available to other researchers.
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dustin C Lee, PhD principal investigator
Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 300 mg Cannabidiol and 600 mg Cannabidiol in people with Tobacco Use and Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dustin C Lee, PhD (410-550-4035, dlee214@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biochemically-verified tobacco abstinence as assessed by expired carbon monoxide (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.