Cannabidiol for Quitting Smoking

Overseen By Dustin C Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Smoking cessation drugs

Disqualifiers: Substance use disorders, Suicidal behavior, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking any over-the-counter drugs, herbal supplements, vitamins, or prescription medications (except birth control) at least 14 days before the study sessions, as they might interfere with the study results or your safety.

What data supports the effectiveness of the drug Cannabidiol (CBD) for quitting smoking?

Research suggests that CBD may help reduce nicotine withdrawal symptoms and anxiety, making it easier to quit smoking. In studies, CBD has been shown to decrease cigarette consumption and reduce the severity of withdrawal symptoms in both humans and animal models. ^{1 2 3 4 5}

Is cannabidiol (CBD) safe for human use?

CBD is generally considered safe for human use, but it can cause side effects like liver issues, sedation, and diarrhea, especially when interacting with other medications. It's important to monitor for these effects and consult with a healthcare provider, particularly if using other drugs. ^{6 7 8 9 10}

How does the drug Cannabidiol (CBD) help people quit smoking?

Cannabidiol (CBD) is unique in helping people quit smoking by reducing withdrawal symptoms and anxiety, which are common challenges during nicotine abstinence. Unlike traditional nicotine replacement therapies, CBD works by modulating the endocannabinoid system, potentially reducing cravings and cigarette consumption. ^{1 2 3 4 11}

What is the purpose of this trial?

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.

Research Team

Dustin C Lee, PhD

Principal Investigator

Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center

Eligibility Criteria

Adults aged 18-65 who smoke more than 10 cigarettes a day for over a year, want to quit in the next two months, and are generally healthy can join. They must be willing to try quitting as part of the study and use effective contraception if applicable. People with other substance use disorders, current serious health issues, or on certain medications cannot participate.

Inclusion Criteria

I want to quit smoking within the next two months.

Have provided written informed consent

I am willing to use effective birth control during and after the study.

Exclusion Criteria

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

I have a history of serious heart rhythm problems or vasospastic disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive twice-daily oral CBD and matched placebo in a double-blind, within-subject, double-crossover design to evaluate short-term tobacco abstinence

6 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cannabidiol

Trial Overview The trial is testing whether oral cannabidiol (CBD), at doses of either 300 mg or 600 mg, helps people stop smoking tobacco compared to a placebo. It aims to see if CBD increases short-term abstinence from tobacco and understand how it might change smoking behavior.

Participant Groups

Group I: Within-Subjects Dose Conditions Experimental Treatment 3 Interventions

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.

Group II: Additional Within-Subjects Dose Conditions Experimental Treatment 3 Interventions

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.

Cannabidiol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in European Union as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome
• Seizures associated with tuberous sclerosis complex

Approved in Canada as Epidiolex for:

• Seizures associated with Lennox-Gastaut syndrome
• Seizures associated with Dravet syndrome

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study with male and female Wistar rats, chronic treatment with cannabidiol (CBD) significantly reduced withdrawal symptoms from nicotine, including somatic signs and hyperalgesia, suggesting its potential as a therapeutic option for nicotine dependence.

The study found no dose-response relationship for CBD, indicating a possible ceiling effect, which means lower doses might also be effective in alleviating withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol reduces withdrawal symptoms in nicotine-dependent rats. Smith, LC., Tieu, L., Suhandynata, RT., et al.[2022]

In a pilot study involving 24 smokers, those using cannabidiol (CBD) inhalers reduced their cigarette consumption by approximately 40% over one week, while the placebo group showed no change.

The positive effects of CBD on reducing smoking urges appeared to persist even after the treatment period, suggesting its potential as a therapeutic option for nicotine addiction that deserves further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol reduces cigarette consumption in tobacco smokers: preliminary findings. Morgan, CJ., Das, RK., Joye, A., et al.[2022]

A review of 207 studies identified only 3 randomized clinical trials (RCTs) specifically focused on using cannabidiol (CBD) for cannabis use disorder, highlighting a significant gap in research for CBD's efficacy in treating substance use disorders.

Ongoing trials are enhancing outcome measures by incorporating peripheral biomarkers from the endocannabinoid system, which may help predict how well individuals respond to CBD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers. Morel, A., Lebard, P., Dereux, A., et al.[2021]

In a study involving 20 daily nicotine-containing e-cigarette users, oral administration of 320 mg of CBD significantly reduced self-reported nicotine withdrawal symptoms and anxiety after a 4-hour abstinence period.

These promising results suggest that CBD could be a helpful aid for individuals trying to quit e-cigarettes, indicating further research on its effectiveness in cessation efforts is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Reduces Nicotine Withdrawal Severity and State Anxiety During an Acute E-cigarette Abstinence Period: A Novel, Open-Label Study. Gournay, LR., Petry, J., Bilsky, S., et al.[2023]

In a study involving 30 dependent cigarette smokers, a single 800 mg dose of cannabidiol (CBD) significantly reduced the attentional bias and pleasantness ratings towards cigarette-related cues after overnight abstinence, compared to a placebo.

CBD did not affect craving or withdrawal symptoms, indicating it may help reduce the appeal of smoking cues without causing side effects, making it a potential aid for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol reverses attentional bias to cigarette cues in a human experimental model of tobacco withdrawal. Hindocha, C., Freeman, TP., Grabski, M., et al.[2021]

Nearly 50% of CBD users experienced adverse drug events (ADEs), with common issues including elevated liver enzymes, sedation, and sleep disturbances, indicating a significant safety concern.

CBD has a high potential for drug-drug interactions (DDIs) due to its effects on drug metabolism, particularly with enzymes like CYP3A4 and CYP2C19, suggesting that careful monitoring and dose adjustments may be necessary for patients on multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. Brown, JD., Winterstein, AG.[2020]

A systematic review of 4186 studies on cannabidiol (CBD) revealed that most research focuses on neurological outcomes, with significant adverse events reported in this area, highlighting the need for careful assessment of CBD's safety.

There is a notable gap in research regarding the reproductive and developmental toxicity of CBD, suggesting that future studies should prioritize these areas to establish safe intake levels for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. Henderson, RG., Franke, KS., Payne, LE., et al.[2023]

In a study involving 20 patients with cannabis use disorder, 30% of participants reduced their daily cannabis consumption by at least 50% after 12 weeks of using inhaled CBD, indicating potential efficacy in treating this condition.

The study suggests that inhalation of CBD allows users to adjust their dosage based on withdrawal symptoms and cravings, highlighting a flexible and user-friendly method of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of Inhaled Cannabidiol in Cannabis Use Disorder: The Pilot Study Cannavap. Cleirec, G., Desmier, E., Lacatus, C., et al.[2022]

A systematic review of 12 clinical trials involving 803 participants found that cannabidiol (CBD) is associated with a higher likelihood of withdrawal due to adverse effects compared to placebo, particularly in studies related to childhood epilepsy.

While CBD generally appears well tolerated, significant adverse effects such as abnormal liver function tests and sedation were noted, especially in combination with other medications, highlighting the need for careful monitoring of drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. Chesney, E., Oliver, D., Green, A., et al.[2021]

Serious suspected adverse reactions (SARs) to unlicensed cannabidiol (CBD) products were found to be 18.9% of all adverse events, with a higher frequency in men and adults, indicating a need for careful monitoring of its use.

The most common adverse effects associated with unlicensed CBD included mental disorders, hepatic disorders, and worsening of pre-existing epilepsy, particularly in patients also taking antiepileptic medications like clobazam and valproic acid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. Calapai, F., Esposito, E., Ammendolia, I., et al.[2023]

In a study involving 78 adults with moderate to severe cocaine use disorder, daily administration of 800 mg of cannabidiol (CBD) did not significantly reduce drug-cue-induced cravings compared to a placebo.

The study also found no difference in the time to relapse between participants taking CBD and those on placebo, indicating that CBD may not be an effective treatment for preventing relapse in cocaine use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. Mongeau-Pérusse, V., Brissette, S., Bruneau, J., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Cannabidiol reduces withdrawal symptoms in nicotine-dependent rats. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Cannabidiol reduces cigarette consumption in tobacco smokers: preliminary findings. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Trials of Cannabidiol for Substance Use Disorders: Outcome Measures, Surrogate Endpoints, and Biomarkers. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol Reduces Nicotine Withdrawal Severity and State Anxiety During an Acute E-cigarette Abstinence Period: A Novel, Open-Label Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Cannabidiol reverses attentional bias to cigarette cues in a human experimental model of tobacco withdrawal. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Potential Adverse Drug Events and Drug-Drug Interactions with Medical and Consumer Cannabidiol (CBD) Use. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Cannabidiol Safety Data: A Systematic Mapping Study. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Efficiency of Inhaled Cannabidiol in Cannabis Use Disorder: The Pilot Study Cannavap. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of unlicensed cannabidiol in European countries. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Cannabidiol as a treatment for craving and relapse in individuals with cocaine use disorder: a randomized placebo-controlled trial. [2021]