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A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

NCT07766655 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2026-08-14

No results posted yet for this study

Summary

This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.

Conditions

  • Smoking Cessation

Interventions

DRUG

AXS-05 (dextromethorphan-bupropion)

AXS-05 tablets, taken twice daily for 12 weeks.

DRUG

Bupropion

Bupropion tablets, taken twice daily for 12 weeks.

DRUG

Placebo

Placebo tablets, taken twice daily for 12 weeks.

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07766655 on ClinicalTrials.gov