AXS-05 Phase II Trial on Smoking Behavior

NCT03471767 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00089413
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Smoking cessation; Nicotine dependence; Bupropion; DXM; Nicotine addiction; Cigarette smoking; Dextromethorphan

Outcome Measures

Primary Outcomes (2)

• Change in Smoking Intensity

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

  Baseline (V1), 3-Week Follow-Up Visit (V4)

• Percentage of Participants Who Experienced a More Than 50% Reduction in Expired Carbon Monoxide (CO) Levels

  A biochemical marker of smoking intensity.

  Baseline (V1), 3-Week Follow-Up Visit (V4)

Secondary Outcomes (5)

• Change in Smoking Behavior

  3-Week Follow-Up Visit (V4), 4-Week Follow-Up Visit (V5)

• Medication Adherence

  Baseline (V1), 3-Week Follow-Up Visit (V4)

• Medication Tolerance by Self-Reported Side Effects

  Baseline (V1), 3-Week Follow-Up Visit (V4)

• Medication Tolerance by Serious Adverse Events

  Baseline (V1), 4-Week Follow-Up Visit (V5)

• Urinary Levels of Dextromethorphan

  3-Week Follow-Up Visit (V4)

Study Arms (2)

AXS-05

EXPERIMENTAL

Participants will receive AXS-05 (Dextromethorphan Immediate Release + Bupropion Sustained Release) for 4 weeks and will be instructed to 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: AXS-05

Bupropion SR

ACTIVE COMPARATOR

Participants will receive Bupropion SR (Bupropion Sustained Release) for 4 weeks and will be instructed to 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

Interventions

AXS-05 DRUG

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.

Also known as: Bupropion/dextromethorphan

AXS-05

Bupropion SR DRUG

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.

Also known as: Wellbutrin SR, Zyban SR

Bupropion SR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• James Davis: lead
• Axsome Therapeutics, Inc.: collaborator

Study Sites (1)

Duke Center for Smoking Cessation

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking; Tobacco Use Disorder

Interventions

Bupropion; Dextromethorphan

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: James Davis, MD
• Organization: Duke University

james.m.davis@duke.edu

919-668-5055

Study Officials

• James M Davis, MD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director, Duke Center for Smoking Cessation

Model Details: Participants are randomized to either take AXS-05 or BUP SR in parallel for the duration of the study.

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 21, 2018
• Study Start: March 25, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: December 19, 2022
• Results First Posted: October 12, 2022

Record last verified: 2022-12

Locations

US (1)