Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

Loma Linda University (LLU)

Status and phase: Completed; Phase 4

Conditions: Nicotine Addiction

Treatments: Drug: Cytisine; Drug: Nicotine Replacement Therapy (NRT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04126135

5170400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,307 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,307 participants in 2 patient groups

Usual Care Group

Active Comparator group

Description:

Subjects are asked to completely stop smoking on their quit day and use a daily Nicotine Replacement Therapy (NRT) patch for 25 days.

Treatment:

Drug: Nicotine Replacement Therapy (NRT)

Treatment Group

Experimental group

Description:

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.

Treatment:

Drug: Cytisine