Trial · NCT03471767

AXS-05 Phase II Trial on Smoking Behavior

NCT03471767, Phase 2, Completed, James Davis; results first posted 2022-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. AXS-05 Phase II Trial on Smoking Behavior. Trials, record NCT03471767. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03471767

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: AXS-05 Phase II Trial on Smoking Behavior
NCT number: NCT03471767
Status: Completed
Phases: Phase 2
Enrollment: 58 participants, actual
Lead sponsor: James Davis
Conditions: Smoking Cessation, Smoking, Cigarette, Nicotine Dependence
Interventions: AXS-05, Bupropion SR
First posted: 2018-03-21
Last updated: 2022-12-19
Results first posted: 2022-10-12

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Smoking Intensity	Baseline (V1), 3-Week Follow-Up Visit (V4)	Smoking intensity refers to the number of cigarettes smoked per day.
Primary	Percentage of Participants Who Experienced a More Than 50% Reduction in Expired Carbon Monoxide (CO) Levels	Baseline (V1), 3-Week Follow-Up Visit (V4)	A biochemical marker of smoking intensity.
Secondary	Change in Smoking Behavior	3-Week Follow-Up Visit (V4), 4-Week Follow-Up Visit (V5)	7-day point prevalence smoking abstinence. Measured by composite self-report diaries and biochemically confirmed via expired CO and salivary cotinine.
Secondary	Medication Adherence	Baseline (V1), 3-Week Follow-Up Visit (V4)	Medication adherence is measured by composite self-reported diaries.
Secondary	Medication Tolerance by Self-Reported Side Effects	Baseline (V1), 3-Week Follow-Up Visit (V4)	Number of participants who scored 3 or higher on a 7-point Likert scale ranking severity of side effects (1-2 mild; 3-5 moderate; 6-7 severe).
Secondary	Medication Tolerance by Serious Adverse Events	Baseline (V1), 4-Week Follow-Up Visit (V5)	Measured by FDA reporting guidelines on adverse event or serious adverse event designation.
Secondary	Urinary Levels of Dextromethorphan	3-Week Follow-Up Visit (V4)	Measured via Urinary Dextromethorphan testing.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Smoking Intensity	Baseline (V1), 3-Week Follow-Up Visit (V4)		change in cigarettes per day	MEAN
SECONDARY	Change in Smoking Behavior	3-Week Follow-Up Visit (V4), 4-Week Follow-Up Visit (V5)	Not all participants participated in this abstinence test.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Medication Adherence	Baseline (V1), 3-Week Follow-Up Visit (V4)	Not all participants participated in the full reporting period (dropped out or withdrew).	percentage of adherence	MEAN
SECONDARY	Medication Tolerance by Self-Reported Side Effects	Baseline (V1), 3-Week Follow-Up Visit (V4)		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Medication Tolerance by Serious Adverse Events	Baseline (V1), 4-Week Follow-Up Visit (V5)	There were no study-related serious adverse events.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Urinary Levels of Dextromethorphan	3-Week Follow-Up Visit (V4)	Data not collected on the Bupropion SR group. Some individuals in the AXS-05 group had missing data or withdrew/dropped out early.	ng/mL	MEAN
PRIMARY	Percentage of Participants Who Experienced a More Than 50% Reduction in Expired Carbon Monoxide (CO) Levels	Baseline (V1), 3-Week Follow-Up Visit (V4)		percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group13

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Smoking Intensity	AXS-05	-8.49	Standard Error 0.37	change in cigarettes per day
Change in Smoking Intensity	Bupropion SR	-6.79	Standard Error 0.39	change in cigarettes per day
Change in Smoking Behavior	AXS-05	16		Participants
Change in Smoking Behavior	Bupropion SR	12		Participants
Medication Adherence	AXS-05	97.08	Standard Deviation 5.97	percentage of adherence
Medication Adherence	Bupropion SR	96.60	Standard Deviation 5.27	percentage of adherence
Medication Tolerance by Self-Reported Side Effects	AXS-05	7		Participants
Medication Tolerance by Self-Reported Side Effects	Bupropion SR	5		Participants
Medication Tolerance by Serious Adverse Events	AXS-05	0		Participants
Medication Tolerance by Serious Adverse Events	Bupropion SR	0		Participants

1 to 10 of 13Source ClinicalTrials.gov

See all 13 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AXS-05	31
Overall Study	STARTED	Bupropion SR	27
Overall Study	COMPLETED	AXS-05	25
Overall Study	COMPLETED	Bupropion SR	23
Overall Study	NOT COMPLETED	AXS-05	6
Overall Study	NOT COMPLETED	Bupropion SR	4

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dry Mouth	Gastrointestinal disorders	AXS-05	2	31
other	Dry Mouth	Gastrointestinal disorders	Bupropion SR	3	27
other	Headache	Nervous system disorders	AXS-05	0	31
other	Headache	Nervous system disorders	Bupropion SR	2	27
other	Insomnia/Sleep Disturbance	Psychiatric disorders	AXS-05	2	31
other	Insomnia/Sleep Disturbance	Psychiatric disorders	Bupropion SR	2	27
other	Abnormal/Vivid Dreams	Psychiatric disorders	AXS-05	0	31
other	Abnormal/Vivid Dreams	Psychiatric disorders	Bupropion SR	1	27
serious	Stroke	Nervous system disorders	AXS-05	0	31	0
serious	Stroke	Nervous system disorders	Bupropion SR	1	27	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AXS-05	0	31
Total, all-cause mortality	Bupropion SR	0	27
Total, other adverse events	AXS-05	4	31
Total, other adverse events	Bupropion SR	8	27
Total, serious adverse events	AXS-05	2	31
Total, serious adverse events	Bupropion SR	1	27

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AXS-05 vs Bupropion SR: Medication Tolerance by Self-Reported Side Effects	Trial comparisons
AXS-05 vs Bupropion SR: Medication Tolerance by Serious Adverse Events	Trial comparisons
AXS-05 vs Bupropion SR: Change in Smoking Behavior	Trial comparisons
AXS-05 vs Bupropion SR: deaths from any cause	Trial comparisons
AXS-05 vs Bupropion SR: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03471767

GET https://conductscience.org/api/trials/v1/NCT03471767/registered

API reference For AI assistants