Cannabidiol for Nicotine Addiction

(CREWS Trial)

Overseen By Dustin C. Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Disqualifiers: Substance use disorder, Illicit drugs, Pregnancy, others

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

Compensation: Varies

Number of Visits: 7

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cannabidiol (CBD) affects stress and nicotine withdrawal in regular cigarette smokers. Participants will take varying doses of CBD and undergo stress tests to assess its impact on stress and withdrawal symptoms. The trial will compare those who continue smoking with those who abstain for a day before each session. Individuals who have smoked more than five cigarettes daily for over two years and do not plan to quit soon may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to experience its effects.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you take a medication that the study team thinks could affect your safety or the study results, you might not be able to participate.

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

Research has shown that cannabidiol (CBD) can ease nicotine withdrawal symptoms and reduce anxiety when people stop smoking. One study found that CBD lessened the severity of nicotine withdrawal and anxiety in individuals who quit using e-cigarettes. Regarding safety, most people tolerate CBD well, with reports indicating few major side effects. Some might experience mild effects like sleepiness or dry mouth, but these are uncommon. Additionally, CBD is used in other treatments and is generally considered safe. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using cannabidiol (CBD) for nicotine addiction because it takes a completely different approach than traditional therapies like nicotine replacement products or prescription medications such as varenicline and bupropion. Unlike these treatments, which focus on replacing or blocking nicotine's effects, CBD targets the endocannabinoid system, which might help reduce cravings and withdrawal symptoms in a new way. Additionally, CBD has a generally favorable safety profile, which could make it an appealing option for those looking for alternatives with fewer side effects.

What evidence suggests that cannabidiol might be an effective treatment for nicotine addiction?

Research has shown that cannabidiol (CBD) might help reduce nicotine addiction. In one study, participants who used a CBD inhaler smoked 40% fewer cigarettes in just one week. Another study found that CBD reduced the frequency of nicotine cravings. CBD also appears to lessen the severity of nicotine withdrawal symptoms. In this trial, participants will be assigned to different treatment arms, receiving varying doses of CBD. These findings suggest that CBD could be a promising option for those trying to quit smoking. ^{1 2 3 4 6}

Who Is on the Research Team?

Dustin C. Lee, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults aged 21-70 who smoke more than 5 cigarettes daily for over 2 years, with a CO level >8 ppm. They must drink less than 14 alcoholic drinks per week and have a normal sleep schedule. Participants willing to use contraception during the study can join, but not those working night shifts or seeking treatment.

Inclusion Criteria

I drink less than 2 alcoholic drinks a day, on average.

I work during the day and sleep at night.

I agree to use effective birth control during and for 30 days after the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 session

1 visit (in-person)

Pre-laboratory Sessions

Participants undergo 3 pre-laboratory phone sessions to prepare for the experimental sessions

3 sessions

3 visits (virtual)

Experimental Laboratory Sessions

Participants receive different doses of CBD and are exposed to stress and nicotine withdrawal challenges

2-3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Cannabidiol

Trial Overview The study tests how CBD (Epidiolex) affects stress and nicotine withdrawal in smokers. It will look at tobacco dependence, withdrawal symptoms, and if there are differences between men and women. Some participants may need to refrain from smoking for 24 hours before sessions.

How Is the Trial Designed?

Group I: Ad Lib (first) Experimental Treatment 1 Intervention

Participants who use tobacco cigarettes and will be randomly assigned to smoking ab lib. Each participant will receive 0, 200, 400 mg of CBD in this arm.

Group II: Abstinence (first) Experimental Treatment 1 Intervention

Participants who use tobacco cigarettes and will be randomly assigned to smoking abstinence for 24 hours before each session. Each participant will receive 0, 200, 400 mg of CBD in this arm.

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+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Citations

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

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. 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. 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 ...

4. 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. (26) ...

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/PMC9945182/

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