NCT04126135

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,307 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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: Six 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=654) or usual care (n=653) 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.

Conditions

• Nicotine Addiction

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-01-27
• Primary completion: 2024-03-04
• Completion: 2024-04-20
• First posted: 2019-10-15
• Last updated: 2024-09-19

Locations

1 site across 1 country: Mongolia