Effectiveness of Different THR Products in Adult Population

NCT05825924 | Unknown Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: W3-030
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a two-arm, parallel randomized controlled trial (RCT) with a treatment period of 12 weeks, and long-term follow-up at 52 weeks which plans to enroll 258 smokers from general adult population. Participants who meet the eligibility criteria and give their informed consent will be randomized (1:1) to one of two treatment arms: (1) E-cigarettes (18mg/ml) with individual counselling (2) Nicotine patches (21mg) with individual counselling. Eligible participants must be at least of legal age allowed for smoking in the country, of either gender, regular smokers (minimum 10 cigarettes/day for at least a year) and interested to stop smoking. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52. Exhaled carbon monoxide assessment will be used at the trial site to quantify biochemically validated smoking abstinence. All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study.

Conditions

Smoking Cessation

Keywords

smoking cessation; tobacco harm reduction; E Cigarettes; LMIC

Outcome Measures

Primary Outcomes (1)

• Point-prevalence abstinence

  Number of participants self-reported abstinence in the past week, with biochemical validation using exhaled CO measurements of ≤ 10 ppm.

  12 weeks

Secondary Outcomes (5)

• Seven-day point prevalence

  7 days for 12 weeks

• Use of tobacco combustible cigarettes

  12 weeks

• Perception of the product

  12 weeks

• Adverse events

  12 weeks

• Physical signs and symptoms associated with withdrawal

  52 weeks

Study Arms (2)

Study Arm A: Electronic Cigarettes (18mg/ml)

ACTIVE COMPARATOR

Participants randomized to study arm A will be provided a free e-cigarette and sufficient nicotine cartridges (18 mg/ml) supply to last till next in person visit. Participants will be instructed to use the device ad libitum one week before their quit day to familiarize themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the e-cigarette exclusively for the next 12 weeks. Smokers often take 10 to 15 puffs over the course of 5 to 8 minutes, repeating this pattern with each cigarette. On the other hand, users of EC may periodically use it throughout the day, and they may or may not take their puffs like those of traditional cigarettes

Device: E-Cigarette

Study Arm B: 21 mg nicotine patches

ACTIVE COMPARATOR

Participants randomized to study arm B will be provided 21 mg nicotine patches supply to last till next in person visit. Participants will use the nicotine patch daily for one week before their quit day to familiarize themselves with its use. On their designated quit day they will stop smoking and use nicotine patches daily for the next 12 weeks. Usually a full-strength patch (15-22 mg of nicotine) daily for four weeks is suggested for use in majority of the smokers, followed by a lower strength patch (5-14 mg of nicotine) for an additional four weeks, depending on their body size and smoking habits

Drug: Nicotine patch

Interventions

E-Cigarette DEVICE

E-cigarettes have been designed to resemble tobacco cigarettes. They include an aerosol generator, sensor, battery and storage area for liquid. They are either disposable or rechargeable. According to a study, e-cigarettes can deliver an average of 1.3 mg (range 0.4 to 2.6 mg) of nicotine from 15 puffs. Average Cmax after e-cigarette use is recorded as 8.4 ng/mL and Tmax achieved between 2 to 5 minutes

Study Arm A: Electronic Cigarettes (18mg/ml)

Nicotine patch DRUG

The nicotine patches are applied on the skin and nicotine is delivered at a steady rate. After administration, the peak blood levels are achieved within 6-10 hours. The levels remain constant, reducing by 25-40% with use of patches once daily. The patch is typically administered every 24 hours for no longer than 12 weeks. The dose of the patches is often determined by daily cigarette consumption and level of addiction.

Also known as: Patch

Study Arm B: 21 mg nicotine patches

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders of legal age allowed for smoking as per country law
• Smoked at least 10 cigarettes a day for the past one year
• Exhaled breath CO (eCO) level \> 10 ppm
• Wish to quit smoking
• Able to conform with all study procedures
• Have a mobile phone
• Expected to be available for follow up will be enrolled as study participants

You may not qualify if:

• Pregnant and breastfeeding women
• Using other smoking cessation medications (including other forms of NRT other than patch, bupropion, clonidine, nortriptyline or varenicline)
• Having any contraindications to products such as cardiovascular history
• Suffering from a major illness with prognosis of less than 1 year

Sponsors & Collaborators

• Foundation for a Smoke Free World INC: lead

Study Sites (1)

South East Hospital and Research Centre

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Smoking Cessation; Vaping

Interventions

Tobacco Use Cessation Devices; Transdermal Patch

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Therapeutics; Equipment and Supplies

Study Officials

• Madeeha Malik, PhD

  Cyntax Health Projects PVT LTD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeeha Malik, PhD

CONTACT

+923325198527; madeehamalik19@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants who are eligible and consent to take part will be randomized (1:1 ratio) to receive products accordingly: A total of 258 participants will be enrolled (129 in each arm) and randomized to Study Arm A: 18 mg nicotine e-cigarettes (ad libitum use) for 12 weeks after the nominated quit date; and Study Arm B: 21 mg nicotine patches (one daily) for 12 weeks after the nominated quit date. The duration of counseling will be at least 30 minutes at site. The duration of counseling through telephone will be at least 10 minutes. Participants will be scheduled for a screening visit and a baseline (BL) visit at the trial site. The participants will be scheduled for eight study visits in total, including five treatment sessions and three follow-up visits, using both face to face interaction at trial site as well as follow up on telephone. Eight study visits are planned at weeks 1, 2, 4, 8, 12, 18, 24, and 52.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 24, 2023
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)