Clinical trial NCT05715164: Electronic Cigarettes and Nicotine Pouches for Smoking Cessation
Official title: Electronic Cigarettes and Nicotine Pouches for Smoking Cessation in Pakistan: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Role of Tobacco Harm Reduction in Smoking Cessation
Efficiency and Efficacy of E-cigarettes and Nicotine Pouches
Adverse Effect of E-cigarettes and Nicotine Pouches
Keywords: E-cigarettes
Nicotine Replacement Therapy
Smoking Cessation
Tobacco Control
Tobacco Harm Reduction
Lead sponsor: Alternative Research Initiative
Sponsor class: OTHER
Collaborators: name: Foundation for a Smoke Free World INC
First posted: 2023-02-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The baseline survey will help to evaluate the smoking status, smoking behavior, socio-demographic characteristics, health status, etc. The three-arm study design would randomize 600 participants into three groups. Of the 600 participants, 200 each will receive e-cigarettes, nicotine pouches, and basic care counseling respectively. Four basic care counseling sessions will be held over the course of 48 weeks. Every 12 weeks, a standard care counseling session will be offered, followed by a study visit to track any alterations in the user's physical or mental health as well as any side effects from using nicotine pouches or e-cigarettes. All participants will complete a follow-up survey at 60 weeks. The provision of e-cigarettes and nicotine pouches will be stopped after the first 48 weeks. The remaining 12 weeks will be without the provision of any intervention and the participants must buy these items on their own.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pakistan is one of the most vulnerable low- and middle-income countries with 29 million adult active tobacco users. Smoking cessation services are lacking as the tobacco control initiatives have largely failed to address the smoking endemic. Over the last five years, Pakistan has witnessed the use of innovative tobacco harm reduction such as e-cigarettes, nicotine pouches, and non-nicotine replacement therapies (non-NRTs). However, their use remains limited.

THR products are imported legally as consumer goods and are taxable. The lack of sufficient data for THR and its application is a challenge in gauging their effectiveness in assisting smokers to quit combustible smoking. Evidence-based studies on e-cigarettes and other nicotine products are required to gauge the effectiveness of e-cigarettes and nicotine pouches as smoking cessation aids.

Keeping in view the study objectives, a sample size of 600 participants will be sufficient to assess the effectiveness of e-cigarettes and nicotine pouches for smoking cessation in Pakistan. Of these, 200 participants each will receive e-cigarettes and nicotine pouches along with basic care counseling, while the remaining 200 participants will only receive basic care counseling for 48 weeks. The association of participants' characteristics with smoking and health status will be based on bivariate and multivariate analysis. The simple t-test and variance analysis will assess the differences in intervention indicators between the control and treatment groups. For the inferential analysis, the average treatment impact of the treatments will find using quasi-experimental techniques such as difference in difference (DID) or Propensity Score Matching (PMS).

This study will be evaluated participants at baseline, after their self-decided "quit date,". The follow-up will be a survey every 12 weeks. Results may inform the public, decision-makers, and researchers about the use of e-cigarettes and nicotine pouches helping smokers to quit smoking or switch to less harmful alternatives in the short- and medium-term periods.


Eligibility criteria: Inclusion Criteria:

* Participants who are at least eighteen years old.
* More than 10 combustible cigarettes smoke a day at the time of study enrollment.
* Smoked cigarettes for at least a year.
* Participants are willing to stop combustible smoking.
* Participants who can sign a written consent form.
* There can only be one applicant per household.
* Own a phone that supports text massaging.

Exclusion Criteria:

* Women who are pregnant.
* Childbearing mothers.
* Currently using other nicotine- and non-nicotine-based cessation therapies.
* Expectant ladies who intend to become pregnant during the trial's participation term.
* Experienced chest pain, or another cardiovascular event or procedure (e.g., heart attack, stroke, insertion of stent, bypass surgery).

Primary outcomes:
measure: Number of participants reported adverse events of e-cigarettes or nicotine pouches
timeFrame: 60 Weeks
measure: Change in the number of combustible cigarettes per day
timeFrame: 60 Weeks
measure: Point-prevalence abstinence
timeFrame: 60 Weeks
Secondary outcomes:
measure: 7-day point-prevalence abstinence and harm reduction
timeFrame: 60 Weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Rawalpindi and Islamabad Centre
state: Punjab
Study officials:
References: