Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT

Smoking Cessation Clinical Trial

Official title:

A Randomized Study to Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With Nicotine Replacement Therapy (NRT)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06088862
• Other study ID #: Adaptive
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 27, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Rose Research Center, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine whether a range of products along the reduced-risk continuum can reduce smoke exposure for individuals who fail to quit smoking using current medically approved nicotine replacement therapy (NRT) products. The strategy will be to offer 325 smokers four weeks of NRT of their choice (gum, lozenge, or nicotine patch) and assess them for quit-smoking status at the end of the period. Seven-day point abstinence will be used to determine responder status at the end of the four-week period (CO of <6 ppm at both CO collection points during that seven-day period and self-report of no smoking during that seven-day period). Those who have not quit, and who therefore have a very low chance of later success (a consistent finding in prior studies and to be verified in the proposed study), will be randomly assigned to either receive a potential "rescue" product (nicotine pouch or ENDS (electronic nicotine delivery system), or remain on NRT (control group).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 325
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Has signed the Informed Consent From (ICF) and is able to read and understand the information provided in the ICF.

2. Is 22 to 65 years of age (inclusive) at screening.

3. Smokes an average of at least 10 commercially available cigarettes per day and has done so for the last 12 months.

4. Expired air CO reading of at least 10 ppm as assessed at the screening session.

5. Interested in switching to an electronic cigarette or nicotine pouch.

6. Willing and able to comply with the requirements of the study.

7. Owns a smart phone with text message and data capabilities compatible with necessary surveys.

Exclusion Criteria:

1. Any participant who has a medical or physical condition that, in the opinion of the investigator (or designee), may adversely affect participant safety, the safety of others, or data validity.

2. Planned use of an FDA-approved smoking cessation product during the study, not provided as part of this protocol.

3. Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.

4. Taking psychoactive medications (e.g., antipsychotics, benzodiazepines, or mood stabilizers).

5. Frequent users (monthly) of smokeless tobacco (chewing tobacco, snuff), cigars (not cigarillos), pipes, hookahs or other non-commercially available combustible or heated tobacco products.

6. Use of nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.

7. Pregnant or nursing (by self-report) or positive pregnancy test.

8. Heterosexually active participant of Childbearing Potential (not sterilized by tubal ligation, oophorectomy, hysterectomy, or other surgical methods, or post-menopausal) that do not agree to practice medically appropriate methods of birth control (or remain abstinent) during the course of the trial. Medically acceptable methods of birth control include: successful vasectomy of male partner, vaginal diaphragm with spermicide, intrauterine device, hormonal birth control (oral, injected, or implanted), condom with spermicide, or sponge with spermicide.

9. Participants who were enrolled in a clinical trial within 30 days of screening.

10. Enrollment numbers met (in sub-group or entire study).

Related Conditions & MeSH terms

• Harm Reduction
• Smoking Cessation

Intervention

Drug:
• Nicoderm
21mg nicotine patch daily; maximum usage 9 weeks
• Nicorette 4Mg Chewing Gum
4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks
• Nicorette Lozenge Product
4mg Nicorette mint lozenge; as needed maximum usage 9 weeks

Other:
• BIDI e-cigarette
BIDI e-cigarette (flavors - Classic, Arctic, and Solar); as needed for maximum of 5 weeks
• on!
4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 5 weeks

Locations

Country	Name	City	State
United States	Rose Research Center	Charlotte	North Carolina
United States	Rose Research Center	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Rose Research Center, LLC	Foundation for a Smoke Free World INC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in smoke exposure for NRT non-responders	Change in expired air CO at week 10 compared to baseline	After 10 weeks
Secondary	Smoking abstinence rates for NRT non-responders	Complete smoking abstinence defined by a self-report of no cigarette smoking (not even a puff).	Week 7 - Week 10
Secondary	Smoking abstinence rates for NRT non-responders	Complete smoking abstinence defined by expired air CO<6 ppm.	Week 7 - Week 10