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Oral Cannabidiol for Tobacco Cessation

NCT05445804 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-07

No results posted yet for this study

Summary

Cannabidiol is a compound found in cannabis plants that is well tolerated, has low abuse liability, and might be an effective medication to promote tobacco cessation. This clinical study will use a validated approach for screening tobacco cessation medications to determine if oral cannabidiol increases short-term tobacco abstinence, and evaluate mechanisms that might explain how cannabidiol alters smoking behavior. Results from this study will provide data on the therapeutic potential of cannabidiol for tobacco cessation.

Conditions

  • Tobacco Use
  • Tobacco Smoking
  • Tobacco Dependence
  • Tobacco Use Disorder
  • Tobacco Use Cessation

Interventions

DRUG

300 mg Cannabidiol

300 mg CBD in Medium Chain Triglyceride oil b.i.d.

DRUG

600 mg Cannabidiol

600 mg CBD in Medium Chain Triglyceride oil b.i.d.

DRUG

Placebo

Medium Chain Triglyceride oil

Sponsors & Collaborators

Principal Investigators

  • Dustin C Lee, PhD · Behavioral Pharmacology Research Unit, Johns Hopkins Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2026-12-01
Completion
2027-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445804 on ClinicalTrials.gov