Recruiting at 28 sites Phase 3 Smoking Cessation

Smoking Cessation study: AXS-05 vs Bupropion

Official title Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)

ClinicalTrials.gov ID: NCT07766655

What this study is testing

What is AXS-05 (dextromethorphan-bupropion)?

AXS-05 (dextromethorphan-bupropion) is an investigational medicine, taken by mouth twice daily, being studied as a potential treatment for smoking cessation.

Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The study aims to find out whether AXS-05 is effective and safe for helping adults stop smoking.
Who it's for
Adults who currently smoke and want to quit.
What's involved
Participants will be randomly assigned to receive AXS-05, a placebo, or bupropion and will attend study visits for medication dispensing and safety checks.
  • Phase 3: a large, late-stage study
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

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

You likely can't join if

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

The study team makes the final eligibility decision.

Where it is enrolling

  • Phoenix, Arizona, United States
  • Little Rock, Arkansas, United States
  • Lemon Grove, California, United States
  • Long Beach, California, United States
  • Pomona, California, United States
  • DeLand, Florida, United States
  • Jacksonville, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Columbus, Georgia, United States
  • Stockbridge, Georgia, United States
  • Skokie, Illinois, United States
  • Evansville, Indiana, United States
  • Kansas City, Missouri, United States
  • Brooklyn, New York, United States
  • Rochester, New York, United States
  • Mount Airy, North Carolina, United States
  • Duncansville, Pennsylvania, United States
  • North Charleston, South Carolina, United States
  • Knoxville, Tennessee, United States

+ 7 more site(s).

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Lemon Grove, California, United States; Long Beach, California, United States; Pomona, California, United States; DeLand, Florida, United States and 21 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.