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

Axsome Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Smoking Cessation

Treatments: Drug: AXS-05 (dextromethorphan-bupropion); Drug: Bupropion; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07766655

AXS-05-SC-301

Details and patient eligibility

About

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.

Full description

Eligible subjects will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 12 weeks, followed by an 18-week follow-up period.

Enrollment: 705 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, aged 18 to 65 (inclusive)

Exclusion criteria

• Unable to comply with study procedures.
• Medically inappropriate for study participation in the opinion of the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

705 participants in 3 patient groups, including a placebo group

AXS-05

Experimental group

Description:

Up to 12 weeks

Treatment:

Drug: AXS-05 (dextromethorphan-bupropion)

Bupropion

Experimental group

Description:

Up to 12 weeks

Treatment:

Drug: Bupropion

Placebo

Placebo Comparator group

Description:

Up to 12 weeks

Treatment:

Drug: Placebo