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NCT03471767 · ClinicalTrials.gov registry record · Phase 2

AXS-05 Phase II Trial on Smoking Behavior

A Phase 2 study of Smoking Cessation and Nicotine Dependence, sponsored by James Davis.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target
1
Study location

NCT03471767: Completed Phase 2 study of Smoking Cessation and Nicotine Dependence, sponsored by James Davis.

NCT03471767 is a Phase 2 study of Smoking Cessation and Nicotine Dependence that has completed, run by James Davis. The registered enrollment target is 58 participants, below the 474-participant average among 188 other Smoking Cessation trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03471767, a Phase 2 study of Smoking Cessation and Nicotine Dependence, has completed, sponsored by James Davis.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Smoking intensity refers to the number of cigarettes smoked per day.

Interventions

  • DRUG AXS-05
  • DRUG Bupropion SR

Study Locations (1)

North Carolina

  • Duke Center for Smoking Cessation - Durham

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2018-03-25
Est. Completion 2019-03-31
Phase Phase 2
James Davis

1 total trials

What the finished NCT03471767 record still lists

NCT03471767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 474-participant average among 188 other Smoking Cessation trials with a reported enrollment target (88% lower).

The record links to 3 conditions, with Smoking Cessation appearing as the primary indexed condition, and to 2 interventions - of which AXS-05 is the first listed.

NCT03471767 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT03471767 about?

NCT03471767 is a clinical study titled "AXS-05 Phase II Trial on Smoking Behavior". This research study is designed with the purpose of evaluating a new drug, combination Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.

What is the current status of trial NCT03471767?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2018-03-25. Estimated completion is 2019-03-31.

What conditions does trial NCT03471767 study?

This clinical trial studies the following conditions: Smoking Cessation, Nicotine Dependence, Smoking, Cigarette.

What interventions are being tested in trial NCT03471767?

The interventions under investigation include: AXS-05 (DRUG), Bupropion SR (DRUG).

Who is sponsoring clinical trial NCT03471767?

This trial is sponsored by James Davis, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03471767 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Smoking Cessation

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03471767's enrollment target sits among peer trials

58 139th of 188 higher than 50 of 188 other Smoking Cessation trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Smoking Cessation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03471767, the US trial registry maintained by the National Library of Medicine. NCT03471767 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.