Tobacco Use study: 300 mg Cannabidiol vs 600 mg Cannabidiol
Official title Oral Cannabidiol for Tobacco Cessation
ClinicalTrials.gov ID: NCT05445804
What this study is testing
What is 300 mg Cannabidiol?
This is an investigational oral liquid medicine being studied to help people stop smoking tobacco. It is designed to interact with the body's endocannabinoid system, which helps control how nicotine feels rewarding.
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
- This study is testing whether taking oral CBD can help people stop smoking. It also looks at how CBD might change smoking habits.
- Who it's for
- You may be able to join if you are a smoker who wants to quit and is willing to try a new treatment.
- What's involved
- You will take a CBD pill at home and report your smoking habits. You may also have a few check‑in visits with the study team.
- Time commitment
- The study lasts about a few weeks, with a few visits to the clinic for follow‑ups.
- 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
- 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
- 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 is enrolling
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Baltimore, Maryland, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.