Clinical trial NCT04126135: Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy
Official title: Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy (NRT) in the National Smoking Cessation Program of Mongolia: A Pragmatic Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nicotine Addiction
Keywords: Smoking Cessation, Nicotine Replacement Therapy, Cytisine
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Mongolian National University of Medical Sciences
First posted: 2019-10-15
Enrollment: 1307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Length of abstinence after 25 day course of Cytisine.
timeFrame: One month after quit date
Secondary outcomes:
measure: Length of abstinence after 25 days of NRT
timeFrame: One month after quit date
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Mongolian National University of Medical Sciences
Study officials:
affiliation: Loma Linda University Health
name: Pramil N Singh, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mongolian National University of Medical Sciences
name: Davaalkham Dambadarjaa, MD
role: PRINCIPAL_INVESTIGATOR
References: