Trial Outcomes & Findings for AXS-05 Phase II Trial on Smoking Behavior (NCT NCT03471767)
NCT ID: NCT03471767
Last Updated: 2022-12-19
Results Overview
Smoking intensity refers to the number of cigarettes smoked per day.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
58 participants
Primary outcome timeframe
Baseline (V1), 3-Week Follow-Up Visit (V4)
Results posted on
2022-12-19
Participant Flow
Participant milestones
| Measure |
AXS-05
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 for 4 weeks.
|
Bupropion SR
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 for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
27
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
AXS-05
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 for 4 weeks.
|
Bupropion SR
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 for 4 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
PI Withdrawal
|
1
|
3
|
Baseline Characteristics
AXS-05 Phase II Trial on Smoking Behavior
Baseline characteristics by cohort
| Measure |
AXS-05
n=31 Participants
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 for 4 weeks.
|
Bupropion SR
n=27 Participants
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 for 4 weeks
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
50.03 years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
46.48 years
STANDARD_DEVIATION 11.34 • n=7 Participants
|
48.38 years
STANDARD_DEVIATION 12.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (V1), 3-Week Follow-Up Visit (V4)Smoking intensity refers to the number of cigarettes smoked per day.
Outcome measures
| Measure |
AXS-05
n=31 Participants
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 for 4 weeks.
|
Bupropion SR
n=27 Participants
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 for 4 weeks
|
|---|---|---|
|
Change in Smoking Intensity
|
-8.49 change in cigarettes per day
Standard Error 0.37
|
-6.79 change in cigarettes per day
Standard Error 0.39
|
PRIMARY outcome
Timeframe: Baseline (V1), 3-Week Follow-Up Visit (V4)A biochemical marker of smoking intensity.
Outcome measures
| Measure |
AXS-05
n=31 Participants
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 for 4 weeks.
|
Bupropion SR
n=27 Participants
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 for 4 weeks
|
|---|---|---|
|
Percentage of Participants Who Experienced a More Than 50% Reduction in Expired Carbon Monoxide (CO) Levels
|
52.0 percentage of participants
|
30.4 percentage of participants
|
SECONDARY outcome
Timeframe: 3-Week Follow-Up Visit (V4), 4-Week Follow-Up Visit (V5)Population: Not all participants participated in this abstinence test.
7-day point prevalence smoking abstinence. Measured by composite self-report diaries and biochemically confirmed via expired CO and salivary cotinine.
Outcome measures
| Measure |
AXS-05
n=24 Participants
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 for 4 weeks.
|
Bupropion SR
n=18 Participants
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 for 4 weeks
|
|---|---|---|
|
Change in Smoking Behavior
|
16 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline (V1), 3-Week Follow-Up Visit (V4)Population: Not all participants participated in the full reporting period (dropped out or withdrew).
Medication adherence is measured by composite self-reported diaries.
Outcome measures
| Measure |
AXS-05
n=30 Participants
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 for 4 weeks.
|
Bupropion SR
n=23 Participants
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 for 4 weeks
|
|---|---|---|
|
Medication Adherence
|
97.08 percentage of adherence
Standard Deviation 5.97
|
96.60 percentage of adherence
Standard Deviation 5.27
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
AXS-05
n=31 Participants
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 for 4 weeks.
|
Bupropion SR
n=27 Participants
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 for 4 weeks
|
|---|---|---|
|
Medication Tolerance by Self-Reported Side Effects
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline (V1), 4-Week Follow-Up Visit (V5)Population: There were no study-related serious adverse events.
Measured by FDA reporting guidelines on adverse event or serious adverse event designation.
Outcome measures
| Measure |
AXS-05
n=31 Participants
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 for 4 weeks.
|
Bupropion SR
n=27 Participants
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 for 4 weeks
|
|---|---|---|
|
Medication Tolerance by Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3-Week Follow-Up Visit (V4)Population: Data not collected on the Bupropion SR group. Some individuals in the AXS-05 group had missing data or withdrew/dropped out early.
Measured via Urinary Dextromethorphan testing.
Outcome measures
| Measure |
AXS-05
n=29 Participants
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 for 4 weeks.
|
Bupropion SR
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 for 4 weeks
|
|---|---|---|
|
Urinary Levels of Dextromethorphan
|
1902.1 ng/mL
Standard Deviation 1304.4
|
—
|
Adverse Events
AXS-05
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Bupropion SR
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AXS-05
n=31 participants at risk
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 for 4 weeks.
|
Bupropion SR
n=27 participants at risk
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 for 4 weeks
|
|---|---|---|
|
Nervous system disorders
Stroke
|
0.00%
0/31 • Approximately four weeks
|
3.7%
1/27 • Number of events 1 • Approximately four weeks
|
|
Infections and infestations
Urinary Tract Infection
|
3.2%
1/31 • Number of events 1 • Approximately four weeks
|
0.00%
0/27 • Approximately four weeks
|
|
Injury, poisoning and procedural complications
Broken Jaw
|
3.2%
1/31 • Number of events 1 • Approximately four weeks
|
0.00%
0/27 • Approximately four weeks
|
Other adverse events
| Measure |
AXS-05
n=31 participants at risk
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 for 4 weeks.
|
Bupropion SR
n=27 participants at risk
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 for 4 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Dry Mouth
|
6.5%
2/31 • Approximately four weeks
|
11.1%
3/27 • Approximately four weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • Approximately four weeks
|
7.4%
2/27 • Approximately four weeks
|
|
Psychiatric disorders
Insomnia/Sleep Disturbance
|
6.5%
2/31 • Approximately four weeks
|
7.4%
2/27 • Approximately four weeks
|
|
Psychiatric disorders
Abnormal/Vivid Dreams
|
0.00%
0/31 • Approximately four weeks
|
3.7%
1/27 • Approximately four weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place