A Study to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults (NCT07766655)
A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Clinical Research Site — Little Rock, Arkansas
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Clinical Research Site — Little Rock, Arkansas
- Clinical Research Site — Jacksonville, Florida
- Clinical Research Site — Orlando, Florida
- Clinical Research Site — Stockbridge, Georgia
- Clinical Research Site — Kansas City, Missouri
- Clinical Research Site — Brooklyn, New York
- Clinical Research Site — Knoxville, Tennessee
- Clinical Research Site — Memphis, Tennessee
- Clinical Research Site — Newport News, Virginia
📞 Contact the Study Coordinator
Phone: (212) 332-5061
Email: AXS-05-SC-301@axsome.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Telephone All Nations Breath of Life — Bethlehem, Pennsylvania
- A Randomized Clinical Trial Assessing Smoking Cessation Interventions In Dental Clinic Smokers — New York, New York
- Pharmacist Intervention to Improve Smoking Cessation — Iowa City, Iowa
- Urban and Reservation Implementation of All Nations Breath of Life — Bethlehem, Pennsylvania
- Smoking Cessation Program in the Construction Sector — Miami, Florida
Explore by condition: All Smoking Cessation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.