What is cannabidiol (CBD) studying for reducing cigarette use?

This trial is studying whether cannabidiol (CBD) can help reduce cigarette smoking in people with Tobacco Use Disorder who want to quit. Researchers are measuring the effects of CBD on nicotine intake and related symptoms. The study is led by the University of California, Los Angeles, aiming to find new treatments to support smoking cessation.

Who may be eligible for this Tobacco Use Disorder clinical trial?

Adults aged 18 to 65 who smoke cigarettes with moderate or higher nicotine dependence and want to quit may be eligible. Both males and females can participate, but people who vape nicotine or have certain medical or psychiatric conditions are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this Tobacco Use Disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should be prepared for any travel costs associated with attending study visits.

Actively Recruiting

Phase 2

Age: 18Years - 65Years

All Genders

ID06218056

Study of Cannabidiol CBD to Help Adults Aged 18-65 Reduce Cigarette Smoking

Led by University of California, Los Angeles · Updated on 2026-04-13

120

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of cannabidiol CBD on reducing cigarette smoking in people with Tobacco Use Disorder who want to quit smoking. The study aims to explore whether CBD can lower nicotine intake and examines related biological markers such as plasma concentrations of CBD and other compounds. This Phase 2 randomized, double-blind, placebo-controlled trial is conducted at a residential substance use treatment center, where cannabis use is prohibited to avoid confounding results. The study addresses the high relapse rates in smoking cessation and the limited research on CBD for this purpose. Participants will be randomly assigned to receive either 800 mg per day of CBD or a placebo for 56 days, taken orally twice daily under supervision. The study includes support via text messages from the National Cancer Institutes Smokefree.gov program to help with quitting. After the treatment period, participants will be followed up at 1 and 3 months. The CBD is given as softgel capsules, and the placebo is designed to match the active capsules in appearance and dosing schedule. During the study, participants will complete several questionnaires about nicotine dependence, withdrawal symptoms, mood, and anxiety at baseline and at various points during treatment and follow-up. Blood, breath, and urine tests will monitor safety, nicotine intake, and CBD levels. Vital signs and clinical labs will be regularly checked to minimize risks. Participants cigarette use and side effects will be recorded daily, and the study includes strict criteria for discontinuation if safety concerns arise. Total study participation may last up to 24 weeks, including follow-up visits.

CONDITIONS

Brief Title

Cannabidiol for Reducing Cigarette Use

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	CBD (800 mg, oral capsules)	Placebo (oral capsules)	Varenicline (standard pharmacotherapy)
What is it?	CBD (cannabidiol) oral capsules, taken at 800 mg daily, are tested as an investigational therapy for reducing cigarette use.	Placebo capsules that match the appearance of the CBD capsules but contain no active ingredient.	Varenicline is a prescription oral medication, approved and guideline-recommended as a pharmacological treatment for smoking cessation.
Role in the trial	Investigational treatment, assigned to participants to evaluate effects on nicotine intake and abstinence.	Comparator arm receiving matched placebo capsules; serves as control for measuring CBD effects.	Not included in this trial; shown for context as the guideline-supported pharmacotherapy typically offered for smoking cessation in similar populations.
Primary use	Being studied for reducing nicotine intake and supporting cigarette abstinence in adults with tobacco dependence.	Serves as a control to compare effects against the investigational CBD treatment.	Used to help adults quit smoking by reducing cravings and withdrawal symptoms as part of standard tobacco dependence therapy.
How is it given?	Participants take four 100 mg CBD capsules orally twice daily (morning and evening) for 8 weeks.	Participants take matched placebo capsules twice daily for 8 weeks to mirror CBD administration.	Varenicline is taken orally, typically as tablets, once or twice daily for up to 12 weeks, with initial dose escalation based on guideline recommendations.
Evidence status	CBD is under study for smoking cessation; preliminary data suggest possible reduction in cigarette consumption, but large-scale efficacy is not established.	Placebo arm serves to establish trial baseline and control for non-specific effects; no evidence for smoking cessation benefit.	Varenicline is proven effective in multiple randomized controlled trials and meta-analyses, demonstrating significant increases in quit rates compared to placebo.
Important limitations	CBD’s effects on smoking cessation are not yet fully established; potential drug-drug interactions, especially via CYP3A4, and exclusion of certain psychiatric or medical populations may limit generalizability.	As a control, placebo does not offer active pharmacological treatment and cannot support clinical benefit for smoking cessation.	Varenicline may cause neuropsychiatric side effects, nausea, or sleep disturbances. Not all individuals tolerate or respond to it, and prescription is contraindicated in some psychiatric or medical conditions.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 65 years
Diagnosed with Tobacco Use Disorder and desire to quit smoking
Smoking at least 5 cigarettes per day or scoring 4 or higher on the Fagerstr�f6m Test for Nicotine Dependence
Recruited from CRI-Help Treatment Center where cannabis use is not allowed
Equal numbers of males and females included
Includes all racial and ethnic groups
Willing to use contraception or abstain if female participant

You will not qualify if you...

Physiological dependence on alcohol or any drug requiring medical detoxification
Currently treated for Opioid Use Disorder with buprenorphine or methadone
Diagnosis of schizophrenia, Bipolar I disorder, psychotic disorder, active suicidal ideation, or suicide attempt within past 12 months
AIDS or current HIV treatment
Clinically significant abnormalities on EKG or major organ system abnormalities
Liver enzyme levels (AST) �3 times upper limit normal or bilirubin �1.5 times upper limit normal
Prothrombin time/INR �3 1.5
Pregnancy or lactation
Abnormal ovarian function based on hormonal tests and ultrasound
Taking medications that strongly interact with CBD metabolism pathways such as CYP3A4 or CYP2C19 inducers or substrates of UGT1A9, UGT2B7, CYP2B6, CYP2C19 enzymes
Use of nicotine vaping products (not allowed at study site)

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 day

Participants complete baseline assessments including blood tests, questionnaires on smoking behavior, withdrawal symptoms, anxiety, depression, and mood state, and create a personalized quit plan.

1 baseline visit (in-person)

Treatment

Duration - 56 days (8 weeks)

Participants receive daily oral doses of cannabidiol (CBD) or placebo for 8 weeks while self-reporting cigarette use and adverse events. Clinical and laboratory assessments are conducted regularly.

Daily self-report questionnaires and weekly in-person visits for assessments

Follow-up

Duration - Up to 3 months post-treatment

Participants undergo follow-up assessments including vital signs, breath carbon monoxide measurement, and behavioral questionnaires at 1 and 3 months after treatment ends.

2 visits (in-person)