A Study of Nicotine Freshmint Mouthspray in E-cigarette Users Willing to Quit

Overview

Sponsor-declared trial summary

Key facts

Sponsor

McNeil AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

23 Apr 2024 → 12 Jan 2026

Decision date (initial)

2024-01-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

McNeil AB

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To compare the efficacy of Nicotine Freshmint Mouthspray vs placebo with respect to rates of continuous abstinence from e-cigarettes.

Secondary objectives 5

1. To compare the efficacy of Nicotine Freshmint Mouthspray vs placebo with respect to rates of 7-day point-prevalence abstinence from e-cigarettes.
2. To assess the efficacy of Nicotine Freshmint Mouthspray vs placebo on craving and withdrawal symptoms
3. To document the compliance with the trial products.
4. To document other tobacco / nicotine-containing product status and vaping status throughout the trial.
5. To evaluate the safety of the trial products.

Conditions and MedDRA coding

Vaping cessation in e-cigarette users

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices, Swedish Medical Products Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 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.
2. 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.
3. Have a history of daily nicotine intake from vaping for at least 3 months prior to screening visit
4. Want to become nicotine free with ‘high’ to ‘very high’ motivation based on the screening motivation assessment.
5. 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.
6. Are exclusive e-cigarette users. Please see the protocol for more detaiils.
7. 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.
8. 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.
9. Able to read and understand the local language.
10. 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.

Exclusion criteria 18

1. 1. Use of other forms of tobacco / nicotine-containing product(s) other than e-cigarettes within 7 days before screening.
2. 2. Use of other forms of tobacco / nicotine-containing product(s) other than e-cigarettes between the screening and baseline visits.
3. 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. 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. 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. 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. 7. History of alcohol abuse, within 6 months of screening.
8. 8. History of non-prescription substance abuse (e.g., amphetamines, benzodiazepines, cocaine, THC, opioids), within 6 months of screening.
9. 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.
10. 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. 11. Use of medications other than contraceptives or those prescribed for well-controlled medical conditions.
12. 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. 13. Is hypersensitive, intolerant, or experienced an allergic reaction to the active ingredient(s) or excipients of drug products used in the trial.
14. 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. 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. 16. History of epilepsy or seizures
17. 17. Has pre-planned surgery, procedures, or personal commitments that would interfere with the conduct of the trial.
18. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Continuous self-reported abstinence from e-cigarettes and CO-verified abstinence from conventional cigarettes from the visit at week 2 up to and including the visits at weeks 6, 30, and 52 respectively, with cotinine verification at visits weeks 30 and 52.

Secondary endpoints 7

1. Continuous self-reported abstinence from e-cigarettes from the visit at week 2 up to and including the visits at weeks 4, 8, 12, 16, 20, and 26, respectively, with CO-verification of smoking abstinence at visits weeks 2, 4, 12, and 26.
2. Point-prevalence 7-day abstinence from e-cigarettes at all post-baseline visits with COverification for smoking abstinence at all visits except for visits at weeks 8, 16, and 20 and with cotinine verification at visits weeks 30 and 52.
3. Separate severity ratings of urge-to-vape and urge-to-smoke in the last 24 hours recorded in the CRFs at weeks 2, 4 and 6 visits. Severity ratings of individual and composite withdrawal symptom scores in the last 24 hours recorded in the CRFs at visits weeks 2, 4 and 6.
4. Average daily number of trial product doses recorded in the CRFs at all post-baseline visits up to and including the visit at week 26.
5. E-cigarette consumption recorded in the CRFs at all post-baseline visits.
6. Separate urge-to-vape and urge-to-smoke severity in the last 24 hours recorded daily in a participant electronic diary (eDiary) from baseline up to the week 2 visit. E-cigarette consumption recorded daily in the eDiary from screening up to the week 2 visit.
7. Safety will be monitored and assessed by reviewing the collection, evaluation, and analysis of participant-reported adverse events.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

McNeil AB

Sponsor organisation

McNeil AB

Address

Norrbroplatsen 2

City

Helsingborg

Postcode

254 42

Country

Sweden

Scientific contact point

Organisation

McNeil AB

Contact name

Clinical operations

Public contact point

Organisation

McNeil AB

Contact name

Clinical operations

Third parties 6

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications