BridgeMD
New treatment option for Tobacco Use
Official title Oral Cannabidiol for Tobacco Cessation
ClinicalTrials.gov ID: NCT05445804
What this study is testing
What is 300 mg Cannabidiol?
300 mg Cannabidiol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tobacco use.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Report interest in quitting tobacco in the next two months
- Are willing to engage in a series of practice quit attempts as part of the study.
You likely can't join if
- 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.
- Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia...
- Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding.
See the full eligibility criteria
- 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
- Are willing to engage in a series of practice quit attempts as part of the study.
- Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests as determined by a licensed medical professional.
- For women of children bearing potential and men with female partners of child-bearing potential, must be willing to use an effective form of contraception during the study and for at least 30 days after the last study...
- 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.
- Have a lifetime history of suicidal behavior (i.e. past suicide attempt), or current suicidal behavior or ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Are currently pregnant, planning to become pregnant in the next three months or are currently breastfeeding.
- Use of an over the counter, systemic or topical drug(s), herbal supplement(s), or vitamin(s) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or...
- Use of a prescription medication (with the exception of birth control prescriptions) within 14 days (or 5 half-lives for that specific drug) of experimental sessions; which, in the opinion of the investigator or...
- Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g. Prinzmetal's angina).
- Have elevated serum liver transaminase (AST or ALT) above 2 x upper limit of normal, or elevated bilirubin above 1.5 x upper limit of normal.
- Are currently enrolled in another clinical trial or have received any drug as part of a research study within 30 days of study participation. \-
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.