Effectiveness of Different THR Products in Adult Population

Smoking Cessation Clinical Trial

Official title:

Randomized, Two Arm Parallel, Clinical Trial to Compare Effectiveness of Different Tobacco Harm Reduction Products in General Adult Population in Low Middle Income Countries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05825924
• Other study ID #: W3-030
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: Foundation for a Smoke Free World INC
• Contact: Madeeha Malik, PhD
• Phone: +923325198527
• Email: madeehamalik19[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a two-arm, parallel randomized controlled trial with a 12 weeks treatment duration and long-term 52 weeks follow-up. Outpatient, and walk-in clinics, and advertising will be used to recruit participants from the general population. Individual counselling regarding smoking cessation will be provided to the participants using EC as well as nicotine patches. Participants included 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 (exhaled carbon monoxide levels above ten ppm regarded as indicator of current smoking). All secondary outcomes and self-reported usage of nicotine patches, EC and cigarettes will be monitored throughout the study. Information about self-reported smoking, usage of EC and nicotine patches, use of other smoking cessation therapy and side effects will be gathered at all follow-up calls and visits.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 258
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Device:
• E-Cigarette
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

Drug:
• Nicotine patch
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.

Locations

Country	Name	City	State
Pakistan	South East Hospital and Research Centre	Islamabad	Federal

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for a Smoke Free World INC

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seven-day point prevalence	Number of Participants who self-report having smoked no cigarettes in the past 7 days	7 days for 12 weeks
Secondary	Use of tobacco combustible cigarettes	Number of cigarettes smoked per day assessed using self reported diaries	12 weeks
Secondary	Perception of the product	Participant views on using e-cigarettes or patches as a smoking cessation aid using Modified Cigarette Evaluation Questionnaire. The mCEQ consist of 12 questions for rating using Likert scale which ranges from 1 (not at all) to 7 (extremely). The answers are combined to form five unique subscales each made up of 1-5 items which quantify (1) Satisfaction, (2) Psychological Reward, (3) Enjoyment of Respiratory Tract Sensations, (4) Craving and (5) Aversion. Difference scores can range from -6 to +6 with positive scores indicating higher dose cigarette produce greater intensity of a subjective effect.	12 weeks
Secondary	Adverse events	Adverse events related to e cigarettes and nicotine patches evaluated using Naranjo Adverse Drug Reaction Probability Scale. Total scores range from -4 to +13 with higher scores indicating definite adverse drug reaction; the reaction is considered definite and adverse reaction is present if the score is 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.	12 weeks
Secondary	Physical signs and symptoms associated with withdrawal	Physical sign and symptoms of withdrawal using Fagerstrom test for nicotine dependence. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are computed to yield a total score of 0-10. The higher the total Fagerstrom score, the more intense is the participant's physical dependence on nicotine.	52 weeks