BridgeMD
A Study of Nicotine Freshmint Mouthspray in E-cigarette Users Willing to Quit
EU CTIS ID: 2023-505036-35-00
What this study is testing
To compare the efficacy of Nicotine Freshmint Mouthspray vs placebo with respect to rates of continuous abstinence from e-cigarettes.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has signed and dated the informed consent document before participating in any trialspecific procedures, indicating the participant has been informed of all pertinent aspects of the trial.
- Is able to comprehend the requirements of the trial (based upon clinical site personnel’s assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified within the protocol.
- Is a healthy participant over and including the age of 18 years. Healthy is defined as the absence of clinically relevant abnormalities as judged by the investigator.
- Have a history of daily nicotine intake from vaping for at least 3 months prior to screening visit
- Want to become nicotine free with ‘high’ to ‘very high’ motivation based on the screening motivation assessment.
- Are classified as either moderately or highly dependent on the Penn State Electronic Cigarette Dependence Index (PS-ECDI), which corresponds to a total score of 9 or greater.
You likely can't join if
- 1. Use of other forms of tobacco / nicotine-containing product(s) other than e-cigarettes within 7 days before screening.
- 10. Participants cannot have used marijuana for 28 days prior to screening and/or who have any plans to at any point throughout the trial, including prescription.
- 11. Use of medications other than contraceptives or those prescribed for well-controlled medical conditions.
- 12. Females who are pregnant or breastfeeding, or planning to become pregnant, or males who have partners who are pregnant or are planning to become pregnant.
- 13. Is hypersensitive, intolerant, or experienced an allergic reaction to the active ingredient(s) or excipients of drug products used in the trial.
- 14. Participating in a clinical trial and/or treated with any investigational product within 28 days or 5 half-lives, whichever is longer, before screening.
See the full eligibility criteria
Who can join
- Has signed and dated the informed consent document before participating in any trialspecific procedures, indicating the participant has been informed of all pertinent aspects of the trial.
- Is able to comprehend the requirements of the trial (based upon clinical site personnel’s assessment) and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified within the protocol.
- Is a healthy participant over and including the age of 18 years. Healthy is defined as the absence of clinically relevant abnormalities as judged by the investigator.
- Have a history of daily nicotine intake from vaping for at least 3 months prior to screening visit
- Want to become nicotine free with ‘high’ to ‘very high’ motivation based on the screening motivation assessment.
- Are classified as either moderately or highly dependent on the Penn State Electronic Cigarette Dependence Index (PS-ECDI), which corresponds to a total score of 9 or greater.
- Are exclusive e-cigarette users. Please see the protocol for more detaiils.
- For females: Postmenopausal state (i.e. at least 1 year without menses without an alternative medical condition prior to the first IP administration) or premenopausal /perimenopausal state with an effective means of contraception.
- For males: No pregnant or lactating spouse or partner at screening and willingness to utilize an acceptable form of birth control with spouse or any potential partner during the trial and for 30 days thereafter.
- Able to read and understand the local language.
What rules you out
- 1. Use of other forms of tobacco / nicotine-containing product(s) other than e-cigarettes within 7 days before screening.
- 10. Participants cannot have used marijuana for 28 days prior to screening and/or who have any plans to at any point throughout the trial, including prescription.
- 11. Use of medications other than contraceptives or those prescribed for well-controlled medical conditions.
- 12. Females who are pregnant or breastfeeding, or planning to become pregnant, or males who have partners who are pregnant or are planning to become pregnant.
- 13. Is hypersensitive, intolerant, or experienced an allergic reaction to the active ingredient(s) or excipients of drug products used in the trial.
- 14. Participating in a clinical trial and/or treated with any investigational product within 28 days or 5 half-lives, whichever is longer, before screening.
- 15. Is related to persons involved directly or indirectly with the conduct of this trial (i.e., principal investigator, sub-investigators, trial coordinators, other trial personnel, employees of J&J subsidiaries, contractors of J&J, and the families of each).
- 16. History of epilepsy or seizures
- 17. Has pre-planned surgery, procedures, or personal commitments that would interfere with the conduct of the trial.
- 18. Other clinically significant severe, acute or chronic, medical or psychiatric condition(s) that may increase the risk associated with trial participation or investigational product administration or may interfere with a participants participation and/or the interpretation of trial results, and in the judgment of the medically qualified investigator, would make the participant inappropriate for entry into this trial.
- 2. Use of other forms of tobacco / nicotine-containing product(s) other than e-cigarettes between the screening and baseline visits.
- 3. Use of other smoking cessation medications or aid(s) within 28 days before screening (e.g. NRT, buproprion, varenicline, cytisine, counselling, apps, acupuncture, or hypnosis).
- 4. History of recent or unstable cardiovascular disease, e.g. heart attack or stroke within the last 3 months or unstable or worsening angina pectoris, severe irregular heartbeat, high blood pressure not controlled by medicine, a stomach ulcer, or diabetes not controlled by oral medication only.
- 5. Presence of an oral lesion (suspected malignant lesion and/or erosive lesion) found at the baseline visual mouth inspection, requiring further investigation such as biopsy.
- 6. Presence of oral lesion(s) that, in the opinion of the investigator, cover more than 25% of the mucosal surface of the mouth so that absorption of the IP could be impaired.
- 7. History of alcohol abuse, within 6 months of screening.
- 8. History of non-prescription substance abuse (e.g., amphetamines, benzodiazepines, cocaine, THC, opioids), within 6 months of screening.
- 9. A positive urine drug test at screening with the following exceptions: Participants with a positive urine drug test for an opioid, benzodiazepine, or stimulant prescribed to the participant. The site investigator must independently deem the medication appropriate with no concern for abuse and the participant suitable to be included in the trial. Participants with a positive urine drug test for an opioid who have temporarily taken an over-the-counter medication containing an opioid. The investigator must deem the medication appropriate with no concern for abuse and the participant suitable to be included in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United Kingdom
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 - 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United Kingdom. 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 EU CTIS; the study team decides eligibility.