Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05206370 · ClinicalTrials.gov registry record · Phase 3
A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers
A Phase 3 study, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 792
- Enrollment target
NCT05206370: Completed Phase 3 study, sponsored by Achieve Life Sciences.
NCT05206370 is a Phase 3 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 792 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05206370, a Phase 3 study, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 792 participants
- Enrollment target
Study Summary
This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for treatment duration of 84 days/12 weeks.
Primary Outcome
Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤ 10 parts per million (ppm).
Interventions
- DRUG Placebo
- DRUG Cytisinicline
- BEHAVIORAL Behavioral support
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 792 participants |
| Start Date | 2022-01-20 |
| Est. Completion | 2023-03-21 |
| Phase | Phase 3 |
What the finished NCT05206370 record still lists
NCT05206370 is an interventional study that assigns participants to a tested intervention. The registered 792 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05206370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05206370 about?
NCT05206370 is a clinical study titled "A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers". This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline TID for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for treatment duration of 84 days/12 weeks.
What is the current status of trial NCT05206370?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 792 participants. The study started on 2022-01-20. Estimated completion is 2023-03-21.
What interventions are being tested in trial NCT05206370?
The interventions under investigation include: Placebo (DRUG), Cytisinicline (DRUG), Behavioral support (BEHAVIORAL).
Who is sponsoring clinical trial NCT05206370?
This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05206370's enrollment target sits among peer trials
792 429th of 2000 higher than 1,572 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03424005 · 792 participants · Phase 1
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
- NCT05866081 · 792 participants · NA
Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative
- NCT06722352 · 792 participants · NA
Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)
- NCT04967989 · 790 participants · Phase 3
Clarifying the Optimal Application of SLT Therapy Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI