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Completed Phase 3 Interventional

Safety Study of Cytisinicline in Adult Combustible and/or E-cigarette Smokers

ClinicalTrials.gov ID: NCT06435221

Public ClinicalTrials.gov record NCT06435221. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 25, 2026, 12:38 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Open-Label Study Assessing Long-Term Exposure With Cytisinicline 3 mg TID

Study identification

NCT ID
NCT06435221
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Achieve Life Sciences
Industry
Enrollment
479 participants

Conditions and interventions

Interventions

  • Cytisinicline Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 27, 2024
Primary completion
Sep 28, 2025
Completion
Oct 5, 2025
Last update posted
Nov 25, 2025

2024 – 2025

United States locations

U.S. sites
29
U.S. states
23
U.S. cities
29
Facility City State ZIP Site status
Alliance for Multispecialty Research, LLC Mobile Alabama 36608
Alliance for Multispecialty Research, LLC Tempe Arizona 85281
Little Rock Allergy & Asthma Clinical Research Center Little Rock Arkansas 72205
Alliance for Multispecialty Research, LLC Coral Gables Florida 33134
Accel Research Sites Network - DeLand Clinical Research Unit DeLand Florida 32720
Alliance for Multispecialty Research, LLC Fort Myers Florida 33912
Jacksonville Center for Clinical Research Jacksonville Florida 32216
Precision Clinical Research Sunrise Florida 33351
Clinical Research Atlanta Stockbridge Georgia 30281
Alliance for Multispecialty Research, LLC Oak Brook Illinois 60523
MediSphere Medical Research Center, LLC Evansville Indiana 47714
Alliance for Multispecialty Research, LLC Wichita Kansas 67207
Alliance for Multispecialty Research, LLC Lexington Kentucky 40509
Alliance for Multispecialty Research, LLC New Orleans Louisiana 70119
Massachusetts General Hospital - Clinical Genetic Facility Boston Massachusetts 02114
Insight Research Institute Flint Michigan 48507
Alliance for Multispecialty Research, LLC Kansas City Missouri 64114
Alliance for Multispecialty Research, LLC Las Vegas Nevada 89119
Global Medical Institutes LLC; Princeton Medical Institute Princeton New Jersey 08540
Rochester Clinical Research, LLC Rochester New York 14609
Centricity Research Columbus Ohio Multispecialty Columbus Ohio 43213
Alliance for Multispecialty Research, LLC Norman Oklahoma 73069
Altoona Center for Clinical Research Duncansville Pennsylvania 16635
Coastal Carolina Research Center North Charleston South Carolina 29405
Alliance for Multispecialty Research, LLC Knoxville Tennessee 37909
Clinical Research Associates, Inc. Nashville Tennessee 37203
Clinical Trials of Texas, LLC San Antonio Texas 78229
Health Research of Hampton Roads, Inc. Newport News Virginia 23606
Alliance for Multispecialty Research, LLC Norfolk Virginia 23502

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06435221, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 25, 2025 · Synced Jun 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06435221 live on ClinicalTrials.gov.

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