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Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes

NCT07392125 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2026-02-06

No results posted yet for this study

Summary

This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only.

A total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms:

* Arm B, 12 weeks cytisinicline + behavior support: N=400 or
* Arm A, 12 weeks of placebo+ behavior support: N=400) The primary objective is to assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support).

Conditions

  • Vaping Cessation

Interventions

DRUG

Cytisinicline

Tablet, 3 times a day (TID), 12 weeks

DRUG

Placebo

Tablet, 3 times a day (TID), 12 weeks

BEHAVIORAL

Behavioral Support

16 behavioral support sessions, starting prior to randomization and through Week 12, 3 additional sessions during the follow-up period.

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Julie Ball · Achieve Life Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-11-15
Completion
2027-09-30
FDA Drug
Yes

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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 NCT07392125 on ClinicalTrials.gov