Cannabidiol for Tobacco Addiction

Overseen By Edythe D London, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Los Angeles

Must not be taking: Opioids, Antivirals, CYP3A4 inducers

Disqualifiers: Alcohol dependence, Schizophrenia, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether cannabidiol (CBD) can help people reduce or quit smoking cigarettes. Participants will receive either CBD or a placebo to assess its impact on cigarette use, cravings, and withdrawal symptoms. Individuals who smoke at least five cigarettes a day and are motivated to quit may qualify for the study, provided they are patients at Cri-Help, Inc. in North Hollywood. The trial aims to provide new insights into CBD's potential as a smoking cessation aid. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings on CBD's efficacy.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications that interact with CBD, such as strong inducers of CYP3A4 or CYP2C19, and substrates of UGT1A9, UGT2B7, CYP2B6, CYP2C19. If you are on these medications, you may need to stop them to participate.

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

Research has shown that cannabidiol (CBD) may help people quit smoking. One study found that participants who used a CBD inhaler smoked fewer cigarettes over a week, suggesting that CBD might reduce cigarette use.

Regarding safety, CBD is generally well-tolerated but can cause some side effects. In a study involving 162 people, 79% reported mild unwanted effects, with the most common being sleepiness and fatigue. A smaller number reported more serious issues, such as seizures.

While researchers are testing CBD for new uses like smoking cessation, it is already FDA-approved for treating other conditions. This approval indicates some confidence in its safety, though further research is needed to fully understand its effects on quitting smoking. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for tobacco addiction?

Unlike the standard treatments for tobacco addiction, which often include nicotine replacement therapies or medications like varenicline and bupropion, Cannabidiol (CBD) acts on the body's endocannabinoid system. Researchers are excited about CBD because it offers a new mechanism of action that could help reduce cravings and withdrawal symptoms without the use of nicotine. Additionally, CBD's potential anti-anxiety effects might address some of the psychological challenges associated with quitting tobacco. This makes CBD a promising alternative for those who might not have success with traditional treatments.

What evidence suggests that cannabidiol (CBD) might be an effective treatment for tobacco addiction?

This trial will compare the effects of Cannabidiol (CBD) at a dose of 800 mg with a placebo for tobacco addiction. Research has shown that cannabidiol (CBD) might help people smoke fewer cigarettes. In one study, participants who used a CBD inhaler smoked significantly less in just one week. Another study found that CBD eased quitting by reducing nicotine withdrawal symptoms. While more research is needed, these early results suggest CBD could be a helpful option for those trying to quit smoking. ^{2 4 6 7 8}

Who Is on the Research Team?

Edythe D London, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for individuals seeking to quit smoking and are currently in a substance abuse treatment program. Participants must desire to stop smoking, be willing to take CBD or placebo twice daily, and complete various tests and questionnaires. They cannot use other cannabis products during the study.

Inclusion Criteria

All racial and ethnic groups are included, with anticipated percentages aligning with recent studies

Participants will not be recruited from the general population due to potential confounding effects of cannabis use in the greater Los Angeles area

I am 18-65, smoke cigarettes, and am in treatment at Cri-Help in North Hollywood.

Exclusion Criteria

I have been diagnosed with schizophrenia, bipolar I, or another psychotic disorder, or I've had thoughts of or attempted suicide in the past year.

I am not on medication that affects certain liver enzymes.

Pregnancy and/or lactation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Baseline assessments including blood plasma cotinine assay and self-reports of smoking-related behaviors

1 day

1 visit (in-person)

Treatment

Participants receive CBD or placebo for 56 days with daily and weekly assessments

8 weeks

Daily assessments, weekly in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1 and 3 months

16 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol (CBD)

Trial Overview The study is testing whether cannabidiol (CBD) can help reduce cigarette use. Participants will receive either a placebo or CBD at doses of 400 mg or 800 mg under supervision for 56 days, with follow-up visits at one and three months after treatment ends.

How Is the Trial Designed?

Group I: Cannabidiol (CBD) 800 mg Active Control 1 Intervention

Sixty participants who meet all eligibility criteria will be randomized to receive CBD (ATL5; Ananda Scientific) at a dose of 800 mg.

Group II: Placebo Placebo Group 1 Intervention

Sixty participants who meet all eligibility criteria will be randomized to receive placebo.

Cannabidiol (CBD) is already approved in United States, European Union 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

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

A single oral dose of 750 mg of cannabidiol (CBD) showed significantly increased exposure when taken with a high-fat/calorie meal, with a 3.8-fold increase in overall exposure (AUC0-∞) and a 5.2-fold increase in maximum concentration (Cmax) compared to fasting.

CBD was well-tolerated with no severe adverse events reported, indicating its safety in healthy adults, while its absorption was also enhanced by low-fat meals, whole milk, and alcohol, albeit to a lesser extent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects. Crockett, J., Critchley, D., Tayo, B., et al.[2021]

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]

Cannabidiol (CBD), specifically in its oral formulation Epidiolex, has been shown to have very low abuse potential and is unlikely to cause physical dependence, as demonstrated by studies in rats and nonhuman primates that showed no significant self-administration or withdrawal signs after chronic treatment.

The pharmacokinetic studies confirmed that the doses used in the experiments resulted in therapeutically relevant plasma levels, supporting the safety and efficacy of CBD for treating seizures in severe forms of epilepsy without the risks associated with addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical Assessment of the Abuse Potential of Purified Botanical Cannabidiol: Self-Administration, Drug Discrimination, and Physical Dependence. Gray, RA., Heal, DJ., Maguire, DR., 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]

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]

Cannabidiol (CBD) is a non-psychoactive compound from cannabis that can counteract the psychotropic effects of THC and has gained popularity in various therapeutic products, especially after the FDA approved Epidiolex® for treating severe epilepsy in children.

Despite its therapeutic potential, there is a lack of consistent international regulations governing the marketing and authorization of CBD products, which raises concerns about product safety and efficacy for consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacology and legal status of cannabidiol. Brunetti, P., Lo Faro, AF., Pirani, F., et al.[2021]

Epidiolex, the only FDA-approved CBD-based drug, has been studied for its medicinal benefits and potential side effects across various clinical trials, focusing on both physiological and neurological conditions.

The review highlights that the outcomes of these trials can vary significantly based on the funding source, which may influence the reported efficacy and safety of Epidiolex and other CBD formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects. Pauli, CS., Conroy, M., Vanden Heuvel, BD., et al.[2020]

Cannabidiol (CBD) has shown promise in preclinical and clinical studies for its ability to inhibit the rewarding effects of addictive substances like cocaine, methamphetamine, and opioids, suggesting its potential as a treatment for substance use disorders.

Despite the encouraging evidence supporting CBD's efficacy in reducing drug addiction behaviors, further research is necessary to fully establish its therapeutic role in addiction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cannabidiol and substance use disorder: Dream or reality. Karimi-Haghighi, S., Razavi, Y., Iezzi, D., et al.[2023]

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]

Citations

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Cannabidiol as a potential cessation therapeutic: Effects on ... We found that CBD produced a significant decrease in the number of nicotine rewards earned, and this effect was evidenced across CBD doses and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11986292/

Efficacy of cannabidiol alone or in combination with Δ‐9‐ ... Nabiximols, which contains CBD and THC, demonstrated positive effects on cannabis withdrawal and craving symptoms. Evidence supporting the ...

3. 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0376871625002315

A multi-site study examining the tobacco withdrawal ... Although the evidence is mixed, several studies suggest that cannabis co-use is associated with poorer tobacco cessation outcomes, which is highly concerning ...

5. liebertpub.com liebertpub.com/doi/10.1089/can.2022.0317

Cannabidiol Reduces Nicotine Withdrawal Severity and ... Results: After controlling for participants' positive CBD expectancies, results were consistent with hypotheses, suggesting CBD reduced both ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052834/

Cannabidiol Adverse Effects and Toxicity - PMC Of the 162 patients in the safety and tolerability analysis, 79% reported AEs, 25% somnolence, 11% convulsions, and more than 5% reported somnolence, fatigue, ...

7. library.samhsa.gov library.samhsa.gov/sites/default/files/pep22-06-04-003.pdf

Cannabidiol (CBD) – Potential Harms, Side Effects, and ... Many concerns have been raised about CBD use, particularly with regard to over-the-counter. CBD products, as there are limited data on their safety and ...

8. pubs.acs.org pubs.acs.org/doi/10.1021/acs.chemrestox.2c00259

Inhibition of Nicotine Metabolism by Cannabidiol (CBD) and 7 ... (25) In one study, the number of cigarettes smoked was decreased by as much as 40% over the course of treatment with a CBD inhaler.