Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

NCT ID: NCT04126135

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2024-04-20

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.

Conditions

Nicotine Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual Care Group

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

Group Type: ACTIVE_COMPARATOR

Nicotine Replacement Therapy (NRT)

Intervention Type: DRUG

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

Treatment Group

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.

Group Type: EXPERIMENTAL

Cytisine

Intervention Type: DRUG

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.

Interventions

Cytisine

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.

Intervention Type: DRUG

Nicotine Replacement Therapy (NRT)

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Mongolian National University of Medical Sciences

OTHER

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Pramil N Singh

Director and Professor, Transdisciplinary Tobacco Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pramil N Singh, DrPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Health

Davaalkham Dambadarjaa, MD

Role: PRINCIPAL_INVESTIGATOR

Mongolian National University of Medical Sciences

Locations

Mongolian National University of Medical Sciences

Ulaanbaatar, , Mongolia

Countries

Mongolia

Other Identifiers

5170400

Identifier Type: -

Identifier Source: org_study_id