Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nicotine Addiction

Intervention / Treatment
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* Drug: Cytisine
* Drug: Nicotine Replacement Therapy (NRT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care Group<br>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)<br>* Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days.<br>|
| Experimental: Treatment Group<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Nicotine Replacement Therapy, Cytisine