Health TrialsbyHealthPanel

Oral Cannabidiol for Tobacco Cessation

ConditionsTobacco UseTobacco SmokingTobacco DependenceTobacco Use DisorderTobacco Use Cessation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Have provided written informed consent

Be between the ages of 18 and 65

Report use of > 10 cigarettes per day for > 1 year with smoking status verified by either a positive breath carbon monoxide test (>8ppm) or urine cotinine test (>200ng/mL) at screening

Report interest in quitting tobacco in the next two months

Disqualifiers

Meet Diagnostic and Statistical Manual-V criteria for substance use disorders except for nicotine or tobacco use disorders

Are currently receiving or interested in immediately receiving behavioral treatment or medication for smoking cessation

Test positive for drugs of abuse (except nicotine) and/or breath alcohol test at study admission

Have a current physical or mental illness judged by the study team to negatively impact participant safety or scientific integrity.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Within-Subjects Dose ConditionsExperimental treatment 3 interventions
Group B: Additional Within-Subjects Dose ConditionsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

biochemically-verified tobacco abstinence as assessed by expired carbon monoxide

Biochemically-verified tobacco abstinence as assessed by expired carbon monoxide part per million during the 4-day practice quit attempt of each drug condition.

Time frame
4 days

Secondary outcomes

1

Smoking Puff Topography

smoking puff topography will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).

Time frame
Change between simulated quit attempt (weeks 2, 4, and 6).
2

Cigarette Purchase Task

Cigarette Purchase Task will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).

Time frame
Change between simulated quit attempt (weeks 2, 4, and 6).
3

Modified Cigarette Evaluation Scale

Modified Cigarette Evaluation Scale will be collected each Monday during simulated quit attempt weeks (2, 4, and 6).

Time frame
Change between simulated quit attempt (weeks 2, 4, and 6).
4

Tobacco Smoking as assessed by self report

Self-reported cigarettes per day

Time frame
Change between simulated quit attempt (weeks 2, 4, and 6).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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