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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between simulated quit attempt (weeks 2, 4, and 6).
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 65 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
biochemically-verified tobacco abstinence as assessed by expired carbon monoxide
Secondary outcome measures
Cigarette Purchase Task
Modified Cigarette Evaluation Scale
Smoking Puff Topography
+5 more

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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,837,447 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,680 Total Patients Enrolled
Dustin C Lee, PhDPrincipal InvestigatorBehavioral Pharmacology Research Unit, Johns Hopkins Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05445804 — Phase 1
Quitting Smoking Research Study Groups: Additional Within-Subjects Dose Conditions, Within-Subjects Dose Conditions
Quitting Smoking Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05445804 — Phase 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05445804 — Phase 1
Quitting Smoking Patient Testimony for trial: Trial Name: NCT05445804 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this medical trial currently available?

"This trial, which was initially posted on the 1st of November 2022, is currently recruiting according to information from clinicaltrials.gov. The particulars have been revised as recently as 22nd November 2022."

Answered by AI

Does this research encompass those aged eighty and above?

"To be qualified to join this study, patients must fall within the 18-65 year old bracket. There are additional trials available for those below eighteen and above sixty-five years of age, totalling 158 studies in total."

Answered by AI

How many individuals are participating in this investigation?

"Affirmative. Clinicaltrials.gov has documented that this research is actively enrolling patients; the trial was first posted on November 1st 2022 and updated most recently on November 22nd 2022. The study aims to include a total of 50 participants across one medical facility."

Answered by AI

Are there any predetermined qualifications for participating in this research endeavor?

"This medical trial intends to recruit 50 individuals aged 18-65 with a history of tobacco dependence. All applicants must provide written consent, report smoking >10 cigarettes daily for the past year (verified through CO or cotinine tests), exhibit an interest in quitting within two months, be medically cleared by a licensed physician, and utilize effective contraception if applicable."

Answered by AI

Is the FDA sanctioning any extra dosage variations in this study?

"Limited clinical data exists confirming the safety and efficacy of Additional Within-Subjects Dose Conditions, so its risk assessment score is marked as a 1."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
What site did they apply to?
Johns Hopkins Behavioral Pharmacology Research Unit

Why did patients apply to this trial?

I want to quit smoking I smoked for 36 years and can't beat the habit.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Oral Cannabidiol for Tobacco Cessation
2022. "Oral Cannabidiol for Tobacco Cessation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05445804.
All > Cbd > Epidiolex
~12 spots leftby Nov 2024
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