Phase 2
Completed N=58
AXS-05 Phase II Trial on Smoking Behavior
Smoking Cessation · Smoking, Cigarette · Nicotine Dependence
Source: ClinicalTrials.gov NCT03471767 ↗
Enrolled (actual)
58
Serious AEs
5.2%
Results posted
Oct 2022
Primary outcomePrimary: Change in Smoking Intensity — -8.49; -6.79 change in cigarettes per day — p=0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Smoking Intensity |
-8.49; -6.79 | 0.05 |
| PRIMARY Percentage of Participants Who Experienced a More Than 50% Reduction in Expired Carbon Monoxide (CO) Levels |
52.0; 30.4 | 0.15 |
| SECONDARY Change in Smoking Behavior |
16; 12 | — |
| SECONDARY Medication Adherence |
97.08; 96.60 | — |
| SECONDARY Medication Tolerance by Self-Reported Side Effects |
7; 5 | — |
| SECONDARY Medication Tolerance by Serious Adverse Events |
0; 0 | — |
| SECONDARY Urinary Levels of Dextromethorphan |
1902.1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Age 18 years or above
- Daily smoker using 10 or more cigarettes per day
- Willing to be smoke-free for 7 days
- Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements.
- Is willing to voluntarily sign and date an informed consent form that is approved by an institutional review board before the conduct of any study procedure.
Key Exclusion Criteria
- Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, bupropion)
- Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco)
- Not pregnant or breastfeeding
- Contraindication to the use of bupropion.
- Additional criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03471767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.