Clinical trial NCT05825924: Effectiveness of Different THR Products in Adult Population
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Smoking Cessation
Keywords: smoking cessation
tobacco harm reduction
E Cigarettes
LMIC
Lead sponsor: Foundation for a Smoke Free World INC
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Point-prevalence abstinence
timeFrame: 12 weeks
Secondary outcomes:
measure: Seven-day point prevalence
timeFrame: 7 days for 12 weeks
measure: Use of tobacco combustible cigarettes
timeFrame: 12 weeks
measure: Perception of the product
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Physical signs and symptoms associated with withdrawal
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: South East Hospital and Research Centre
state: Federal
Study officials:
affiliation: Cyntax Health Projects PVT LTD
name: Madeeha Malik, PhD
role: PRINCIPAL_INVESTIGATOR
References: