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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cannabidiol (CBD), a compound from cannabis plants, can help people quit smoking. Researchers aim to determine if taking CBD orally increases the chances of short-term tobacco abstinence and how it might alter smoking habits. Participants will try different doses of CBD to assess its effectiveness compared to a placebo. This study may suit those who smoke more than 10 cigarettes a day, have done so for over a year, and wish to quit within the next two months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that cannabidiol is likely to be safe for humans?

A previous study showed that using a CBD inhaler helped people smoke fewer cigarettes. Research has also shown that CBD might ease nicotine withdrawal symptoms and reduce discomfort caused by nicotine. Regarding safety, another study found that CBD was generally well-tolerated, with only a few side effects like reduced appetite and some weight loss in certain animals.

This trial is in the early testing stages, so researchers are still gathering information on the safety and effectiveness of CBD for smoking cessation. However, CBD is generally considered to have a low risk of addiction, which is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about cannabidiol (CBD) as a treatment for quitting smoking because it offers a unique approach compared to current options like nicotine replacement therapies and medications such as varenicline and bupropion. Unlike these standard treatments, which typically target nicotine receptors or neurotransmitters like dopamine, CBD is believed to interact with the body's endocannabinoid system, potentially reducing withdrawal symptoms and cravings. Additionally, CBD is a natural compound derived from the cannabis plant, which may appeal to those seeking alternative or holistic approaches to quitting smoking. This new mechanism of action and its natural origin make CBD a promising candidate for smoking cessation.

What evidence suggests that cannabidiol might be an effective treatment for quitting smoking?

Research has shown that cannabidiol (CBD) might help people quit smoking. In studies, participants who used CBD smoked nearly 40% fewer cigarettes compared to those who took a placebo, a substance with no active ingredient. CBD also reduced the discomfort of nicotine withdrawal, easing the quitting process. Some studies found that participants smoked significantly fewer cigarettes over a week when using CBD. Overall, CBD appears promising in helping people stop smoking by easing cravings and withdrawal symptoms. ^{1 3 4 5 6}

Who Is on the Research Team?

Dustin C Lee, PhD

Principal Investigator

Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05445804

Study Details | Oral Cannabidiol for Tobacco Cessation The cannabinoid type 1 receptor receptor inverse agonist/antagonist rimonabant has demonstrated efficacy in increasing tobacco abstinence rates in clinical ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030646031300083X

Cannabidiol reduces cigarette consumption in tobacco ... The main finding of this study was a dramatic reduction in the number of cigarettes smoked across a 7 day period in the individuals using the CBD inhaler.

3. withpower.com withpower.com/trial/phase-1-tobacco-use-disorder-7-2022-06e84

Cannabidiol for Quitting Smoking In studies, CBD has been shown to decrease cigarette consumption and reduce the severity of withdrawal symptoms in both humans and animal models.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10958588/

Cannabidiol as a potential cessation therapeutic: Effects on ... We found that CBD attenuated the somatic signs of nicotine withdrawal and prevented nicotine's hyperalgesia-inducing effects.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6099309/

Cannabidiol reverses attentional bias to cigarette cues in a ... CBD reduced the number of cigarettes reportedly smoked by almost 40%, in comparison to placebo, but did not affect craving 28. No neurocognitive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5569602/

An Update on Safety and Side Effects of Cannabidiol The only observed side effects were reduced sucrose preference, reduced food consumption and body weight in the nonoperated animals treated with CBD (50 mg/kg).