Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

Nicotine Addiction Clinical Trial

Official title:

Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy (NRT) in the National Smoking Cessation Program of Mongolia: A Pragmatic Non-Inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04126135
• Other study ID #: 5170400
• Status: Recruiting
• Phase: Phase 3
• Start date: January 27, 2022
• Est. completion date: January 2024

Study information

• Verified date: November 2023
• Source: Loma Linda University
• Contact: Pramil N Singh, DrPH
• Phone: (909) 651-5732
• Email: psingh[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A pragmatic, single blinded, randomized, controlled non-inferiority trial of Cytisine versus Nicotine Replacement Therapy for continuous abstinence is conducted in the government run primary health hospitals in Mongolia.

Description:

Rationale: In Mongolia, smoking cessation assistance in the governmental health sector consists of behavioral counseling and a 3-week regimen of the NRT patch that costs 175 USD. This cost for low income adults limits effectiveness. A 2014 study documented the superiority and lower cost (<20 USD) of Cytisine versus NRT for continuous abstinence. Trial investigators are testing the comparative effectiveness of Cytisine in the "real life setting" of their national health care system and, if proven effective, will include coverage for Cytisine in the national health plan.

Research Question/Objective: To determine whether a 25 day course of Cytisine tablets is at least as effective as 25 days of NRT in helping smokers remain abstinent for at least one month.

Design: A pragmatic, single blinded, randomized, controlled non-inferiority trial.

Setting: Nine governmental primary care centers in Ulaanbaatar, Mongolia, and outskirts.

Participants: Mongolian adult smokers referred to government-run addiction units.

Intervention and procedures: Participants are randomized to 5 weeks of treatment (n=352) or usual care (n=352) and a 6-month follow-up. The treatment consists of a 25-day course of Cytisine tablets and behavioral counseling. Usual care consists of 25 days of NRT and behavioral counseling.

Measurements: The primary outcome is continuous abstinence (< 5 cigarettes smoked since quit date) at 1 month. Secondary outcomes include 7-day point prevalence abstinence rates and adverse events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Seeking smoking cessation treatment

• Ages 18 years or older

• Currently smoking > 5 cigarettes per day

• Willingness to make quit attempt with pharmacotherapy

• Able to provide verbal and written informed consent

• Have telephone access

Exclusion Criteria:

• Pregnancy or currently breastfeeding

• Current users of NRT (patch, gum, lozenge)

• Current users of non_NRT smoking cessation pharmacotherapy

• Enrolled in another smoking cessation program (non-governmental)

• Clinical disorder that contraindicates use of NRT or Cytisine (heart attack, stroke, severe angina within the past 2 weeks, uncontrolled hypertension, phaeochromocytoma, severe mental illness)

Related Conditions & MeSH terms

• Nicotine Addiction
• Tobacco Use Disorder

Intervention

Drug:
• Cytisine
Subjects will take a 25-day course of Cytisine tablets started during the 4 days before the quit date. They will be asked to reduce smoking during this time.
• Nicotine Replacement Therapy (NRT)
Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days.

Locations

Country	Name	City	State
Mongolia	Mongolian National University of Medical Sciences	Ulaanbaatar

Sponsors (3)

Lead Sponsor	Collaborator
Loma Linda University	Mongolian National University of Medical Sciences, Pfizer

Country where clinical trial is conducted

Mongolia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of abstinence after 25 day course of Cytisine.	Continuous abstinence is defined as <5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day.	One month after quit date
Secondary	Length of abstinence after 25 days of NRT	Continuous abstinence is defined as <5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day.	One month after quit date