Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

Last updated: September 5, 2024
Sponsor: Loma Linda University
Overall Status: Completed

Phase

4

Condition

Tobacco Use Disorder

Substance Abuse

Addictions

Treatment

Cytisine

Nicotine Replacement Therapy (NRT)

Clinical Study ID

NCT04126135
5170400
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 1307
Treatment Group(s): 2
Primary Treatment: Cytisine
Phase: 4
Study Start date:
January 27, 2022
Estimated Completion Date:
April 20, 2024

Study 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.

Connect with a study center

  • Mongolian National University of Medical Sciences

    Ulaanbaatar,
    Mongolia

    Site Not Available

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