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Cannabinoid

Cannabidiol for Quitting Smoking

Phase 1

Recruiting

Led By Dustin C Lee, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between the ages of 18 and 65

Be older than 18 years old

Must not have

Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between simulated quit attempt (weeks 2, 4, and 6).

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trialwill evaluate if cannabidiol, a compound found in cannabis, can help people quit smoking. Results will show if it works and how.

Who is the study for?

Adults aged 18-65 who smoke more than 10 cigarettes a day for over a year, want to quit in the next two months, and are generally healthy can join. They must be willing to try quitting as part of the study and use effective contraception if applicable. People with other substance use disorders, current serious health issues, or on certain medications cannot participate.

What is being tested?

The trial is testing whether oral cannabidiol (CBD), at doses of either 300 mg or 600 mg, helps people stop smoking tobacco compared to a placebo. It aims to see if CBD increases short-term abstinence from tobacco and understand how it might change smoking behavior.

What are the potential side effects?

Cannabidiol is usually well tolerated but can sometimes cause side effects like tiredness, diarrhea, changes in appetite/weight, and some mood changes such as irritability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of serious heart rhythm problems or vasospastic disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between simulated quit attempt (weeks 2, 4, and 6).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between simulated quit attempt (weeks 2, 4, and 6).

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between simulated quit attempt (weeks 2, 4, and 6). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

biochemically-verified tobacco abstinence as assessed by expired carbon monoxide

Secondary study objectives

Cigarette Purchase Task

Modified Cigarette Evaluation Scale

Smoking Puff Topography

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Within-Subjects Dose ConditionsExperimental Treatment3 Interventions

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.

Group II: Additional Within-Subjects Dose ConditionsExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met