Nicotine Addiction
Conditions
Keywords
Smoking Cessation, Nicotine Replacement Therapy, Cytisine
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.
Interventions
DRUGCytisine
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.
DRUGNicotine Replacement Therapy (NRT)
Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days.
Sponsors
Pfizer
Mongolian National University of Medical Sciences
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of abstinence after 25 day course of Cytisine. | One month after quit date | Continuous abstinence is defined as \<5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of abstinence after 25 days of NRT | One month after quit date | Continuous abstinence is defined as \<5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day. |
Countries
Mongolia
Outcome results
None listed