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AXS-05 Phase II Trial on Smoking Behavior

NCT03471767 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2022-12-19

Study results available
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Summary

This research study is designed with the purpose of evaluating a new drug, combination Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.

Conditions

  • Smoking Cessation
  • Smoking, Cigarette
  • Nicotine Dependence

Interventions

DRUG

AXS-05

Dextromethorphan Immediate Release + Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.

DRUG

Bupropion SR

Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.

Sponsors & Collaborators

  • Axsome Therapeutics, Inc.

    collaborator INDUSTRY

  • James Davis

    lead OTHER

Principal Investigators

  • James M Davis, MD · Duke Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-25
Primary Completion
2019-03-31
Completion
2019-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03471767 on ClinicalTrials.gov