Status:
COMPLETED
Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy
Lead Sponsor:
Loma Linda University
Collaborating Sponsors:
Pfizer
Mongolian National University of Medical Sciences
Conditions:
Nicotine Addiction
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
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 ho...
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2024
Estimated Enrollment :
1307 Patients enrolled
Trial Details
Trial ID
NCT04126135
Start Date
January 27 2022
End Date
April 20 2024
Last Update
September 19 2024
Active Locations (1)
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1
Mongolian National University of Medical Sciences
Ulaanbaatar, Mongolia