Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

NCT04126135 | Completed Phase 4 DMC

• 1 other identifier: 5170400
• Study Type: interventional
• Target: 1,307
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Addiction

Keywords

Smoking Cessation, Nicotine Replacement Therapy, Cytisine

Outcome Measures

Primary Outcomes (1)

• Length of abstinence after 25 day course of Cytisine.

  Continuous abstinence is defined as \<5 cigarettes smoked since quit date. Subjects will complete survey to determine number of cigarettes smoked since quit day.

  One month after quit date

Secondary Outcomes (1)

• Length of abstinence after 25 days of NRT

  One month after quit date

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

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

Drug: Nicotine Replacement Therapy (NRT)

Treatment Group

EXPERIMENTAL

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.

Drug: Cytisine

Interventions

Cytisine 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.

Treatment Group

Nicotine Replacement Therapy (NRT) DRUG

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

Usual Care Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Loma Linda University: lead
• Pfizer: collaborator
• Mongolian National University of Medical Sciences: collaborator

Study Sites (1)

Mongolian National University of Medical Sciences

Ulaanbaatar, Mongolia

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

cytisine; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Pramil N Singh, DrPH

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

• Davaalkham Dambadarjaa, MD

  Mongolian National University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Transdisciplinary Tobacco Research Program

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: January 27, 2022
• Primary Completion: March 4, 2024
• Study Completion: April 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)