NCT05825924

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

Status unknown Phase 3 Last updated 20 November 2023

What this trial tests

Phase 3 trial testing E-Cigarette in Smoking Cessation in 258 participants. Status unknown.

Timeline

1 June 2024

Primary endpoint
1 March 2025

1 March 2025

Quick facts

Lead sponsor	Foundation for a Smoke Free World INC
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	258
Start date	1 June 2024
Primary completion	1 March 2025
Estimated completion	1 March 2025
Sites	1 location across Pakistan

Drugs / interventions tested

• E-Cigarette — full drug profile →
• Nicotine patch (nicotine-patch) — full drug profile →

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Foundation for a Smoke Free World INC

Who can join

18 and older, any sex, with Smoking Cessation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Point-prevalence abstinence
  Time frame: 12 weeks
  Number of participants self-reported abstinence in the past week, with biochemical validation using exhaled CO measurements of ≤ 10 ppm.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electronic cigarettes for smoking cessation.
   Lindson N, Butler AR, McRobbie H, Bullen C, et al · · 2024 · cited 94× · PMID 38189560 · DOI 10.1002/14651858.cd010216.pub8
2. Electronic cigarettes for smoking cessation.
   Lindson N, Butler AR, McRobbie H, Bullen C, et al · · 2025 · cited 32× · PMID 39878158 · DOI 10.1002/14651858.cd010216.pub9