Oral Cannabidiol for Tobacco Cessation

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05445804
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 300 mg Cannabidiol — DRUG
    300 mg CBD in Medium Chain Triglyceride oil b.i.d.
  • 600 mg Cannabidiol — DRUG
    600 mg CBD in Medium Chain Triglyceride oil b.i.d.
  • Placebo — DRUG
    Medium Chain Triglyceride oil

Study Details

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.

Key Dates

Start date
Nov 1, 2022
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Feb 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Within-Subjects Dose Conditions
    All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants. Thus, comparisons of the drug conditions on outcome measures will be compared within-subjects (e.g., between drug and placebo) and not between arms.
  • Experimental: Additional Within-Subjects Dose Conditions
    All participants will receive the same drug conditions, but the order in which the participants receive the drug conditions will be counterbalanced across participants. Thus, comparisons of the drug conditions on outcome measures will be compared within-subjects (e.g., between drug and placebo) and not between arms.

Primary Outcome Measure

biochemically-verified tobacco abstinence as assessed by expired carbon monoxide [ Time Frame: 4 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Behavioral Pharmacology Research UnitBaltimoreMaryland21224
Dustin C Lee, PhD
[email protected]
410-550-4035

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