Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05431387 · ClinicalTrials.gov registry record · Phase 2
A Study of Cytisinicline for Vaping Cessation in Adult Smokers
A Phase 2 study, sponsored by Achieve Life Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT05431387: Completed Phase 2 study, sponsored by Achieve Life Sciences.
NCT05431387 is a Phase 2 study that has completed, run by Achieve Life Sciences. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05431387, a Phase 2 study, has completed, sponsored by Achieve Life Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the efficacy and safety profile of 3 mg cytisinicline administered TID for 12 weeks for vaping cessation.
Primary Outcome
Vaping abstinence verified weekly using quantitative saliva cotinine levels at \< 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Interventions
- DRUG Placebo
- BEHAVIORAL Behavioral support
- DRUG cytisinicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 2 |
What the finished NCT05431387 record still lists
NCT05431387 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05431387 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05431387 about?
NCT05431387 is a clinical study titled "A Study of Cytisinicline for Vaping Cessation in Adult Smokers". This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the efficacy and safety profile of 3 mg cytisinicline administered TID for 12 weeks for vaping cessation.
What is the current status of trial NCT05431387?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2022-07-13. Estimated completion is 2023-02-28.
What interventions are being tested in trial NCT05431387?
The interventions under investigation include: Placebo (DRUG), Behavioral support (BEHAVIORAL), cytisinicline (DRUG).
Who is sponsoring clinical trial NCT05431387?
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 NCT05431387's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
- NCT00501826 · 160 participants · Phase 2
Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- NCT00932139 · 160 participants · NA
Effect of Electro-Acupuncture on Blood Pressure
- NCT00992901 · 160 participants · Early Phase 1
Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery
- NCT01515527 · 160 participants · Phase 2
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
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