Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06218056

Evaluating the Efficacy of Cannabidiol for Reducing Cigarette Use

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

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

C

Center For Medicinal Cannabis Research at UC San Diego Health

Collaborating Sponsor

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 Institute's 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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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)

AI-Screening

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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)

Trial Site Locations

Total: 1 location

1

CRI-Help, Inc.

North Hollywood, California, United States, 91601

Actively Recruiting

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Research Team

E

Edythe D London, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Distinct effects of {delta}9-tetrahydrocannabinol and cannabidiol on neural activation during emotional processing.

Paolo Fusar-Poli, José A Crippa, Sagnik Bhattacharyya...

https://pubmed.ncbi.nlm.nih.gov/19124693

Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy.

James W Wheless, Dennis Dlugos, Ian Miller...

https://pubmed.ncbi.nlm.nih.gov/31049885

The effects of cannabidiol (CBD) on Δ⁹-tetrahydrocannabinol (THC) self-administration in male and female Long-Evans rats.

Alison G P Wakeford, Bradley B Wetzell, Rebecca L Pomfrey...

https://pubmed.ncbi.nlm.nih.gov/28682102