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Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

NCT04126135 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1307

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

  • Nicotine Addiction

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Mongolian National University of Medical Sciences

    collaborator OTHER

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Pramil N Singh, DrPH · Loma Linda University Health

  • Davaalkham Dambadarjaa, MD · Mongolian National University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2024-03-04
Completion
2024-04-20

Countries

  • Mongolia

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04126135 on ClinicalTrials.gov