Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nicotine Addiction
• Intervention / Treatment: Drug: Nicotine Replacement Therapy (NRT); Drug: Cytisine

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 700
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pramil N Singh, DrPH; Phone Number: (909) 651-5732; Email: psingh@llu.edu
• Study Contact Backup: Name: Anne Berit Petersen, PhD; Phone Number: 42846 (909) 558-1000; Email: abpetersen@llu.edu

Study Locations

• Mongolia
  • Ulaanbaatar, Mongolia
    • Recruiting
    • Mongolian National University of Medical Sciences
    • Contact: Davaalkham Dambardajaa, MD; Phone Number: 976-11328640; Email: davaalkham@mnums.edu.mn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care Group; Subjects are asked to completely stop smoking on their quit day and use a daily Nicotine Replacement Therapy (NRT) patch for 25 days.	Drug: Nicotine Replacement Therapy (NRT); Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days.
Experimental: Treatment Group; Subjects will start a 25-day course of Cytisine tablets started during the four days before the quit date and are asked to reduce smoking during this time.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Pfizer; Mongolian National University of Medical Sciences
• Investigators: Principal Investigator: Pramil N Singh, DrPH, Loma Linda University Health; Principal Investigator: Davaalkham Dambadarjaa, MD, Mongolian National University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Smoking Cessation, Nicotine Replacement Therapy, Cytisine
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 5170400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes