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A Study of Cytisinicline for Smoking Cessation in Adult Smokers

NCT04576949 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 810

Last updated 2026-01-15

Study results available
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Summary

This placebo-controlled Phase 3 study is being conducted at sites within the United States to evaluate 3 mg cytisinicline 3 times daily (TID) for treatment duration of 42 days/6 weeks and evaluate 3 mg cytisinicline TID for treatment duration of 84 days/12 weeks.

Conditions

  • Smoking Cessation

Interventions

DRUG

Cytisinicline

film-coated oral tablets containing 3 mg cytisinicline

DRUG

Placebo

film-coated oral tablets containing matched placebo

BEHAVIORAL

Behavioral support

Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Nancy Rigotti, MD · Mass General/Harvard Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-13
Primary Completion
2021-12-23
Completion
2021-12-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04576949 on ClinicalTrials.gov