BridgeMD
New treatment option for CBD
Official title Effects of Cannabidiol on Stress and Nicotine Withdrawal
ClinicalTrials.gov ID: NCT07001930
What this study is testing
What is Epidiolex?
Epidiolex is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cbd.
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
- The purpose of this study is to examine the effect of doses of cannabidiol (CBD) during exposure to stress and nicotine withdrawal in nicotine users. The main objectives of the study include examining the effect CBD has on stress, tobacco dependence, tobacco withdrawal, and sex differences between these types of stress.
- 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 21 to 70
You may be able to join if
- Healthy non-treatment seeking adults aged 21-70 (inclusive).
- Use of \> 5 cigarettes per day for \> 2 years. (Use of other tobacco/nicotine products in addition to cigarettes will be acceptable).
- Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level \> 8 ppm.
- Alcohol Use: \< 2 drinks/day on average (\< 14 drinks/week).
- Sleep schedule: No graveyard or third shift work (i.e., participants must report a normal nighttime sleep schedule).
You likely can't join if
- Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
- Test positive for illicit drugs other than cannabis
- Positive breath alcohol test (\>.01 g/210L) at study admission
- Have a current physical or mental illness or takes a medication judged by the study team to negatively impact participant safety or scientific...
- Have a resting heart rate \>100, systolic blood pressure \>160mmHg or \ 100mmHg or \<50mmHg at screening.
See the full eligibility criteria
- Healthy non-treatment seeking adults aged 21-70 (inclusive).
- Use of \> 5 cigarettes per day for \> 2 years. (Use of other tobacco/nicotine products in addition to cigarettes will be acceptable).
- Biological confirmation of cigarette use: have an expired carbon monoxide (CO) level \> 8 ppm.
- Alcohol Use: \< 2 drinks/day on average (\< 14 drinks/week).
- Sleep schedule: No graveyard or third shift work (i.e., participants must report a normal nighttime sleep schedule).
- 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...
- Report current intention to reduce or quit cannabis or tobacco use within the next 30 days
- Meet Diagnostic and Statistical Manual (DSM-5) criteria for a substance use disorder other than alcohol, cannabis, or nicotine
- Test positive for illicit drugs other than cannabis
- Positive breath alcohol test (\>.01 g/210L) at study admission
- Have a current physical or mental illness or takes a medication judged by the study team to negatively impact participant safety or scientific integrity
- Have a resting heart rate \>100, systolic blood pressure \>160mmHg or \ 100mmHg or \<50mmHg at screening.
- Have cold intolerance or a medical condition that might be exacerbated by exposure to cold (e.g. Reynaud's, peripheral neuropathy, trigeminal neuralgia, poorly controlled/uncontrolled hypothyroidism).
- Are currently pregnant, planning to become pregnant in the next three months, or are currently breastfeeding
- Have a history of clinically significant cardiac arrhythmias or vasospastic disease (e.g., Prinzmetal's angina, Raynaud's).
- Have a history of and/or current liver disease, or elevated serum liver transaminase (AST or ALT) above 3 x Upper Limit of Normal (ULN), or elevated bilirubin above 2 x ULN at screening.
- 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, 21 years to 70 years. 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.