AXS-05 Phase II Trial on Smoking Behavior

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

This study aims to investigate the potential efficacy of a combination of two FDA-approved agents, sustained release (SR) Bupropion (BUP) and immediate release (IR) Dextromethorphan (DXM), for the purpose of smoking cessation treatment. DXM, a widely used over-the-counter cough suppressant, is a nicotine receptor antagonist. In fact, studies by Duke's Center for Smoking Cessation (CSC) have shown that administration of DXM leads to a decrease in self-administration of nicotine in nicotine-dependent rats. DXM, however, has not been studied in humans. DXM, when taken alone, is not expected to be useful for treating nicotine dependence in humans given DXM rapidly metabolizes in humans via CYP2D6. As a result, therapeutic concentrations needed to bind to nicotine receptors are not obtained. Therapeutic concentrations of DXM are required, therefore, to allow DXM to bind to nicotine receptors and act as a nicotine antagonist. In order to attain therapeutic concentrations of DXM a metabolism inhibitor must be introduced. BUP is a well-known FDA approved smoking cessation medication that has been shown to inhibit the metabolism of DXM. When BUP is co-administered with DXM to healthy volunteers, a significant increase in DXM plasma levels is observed.

Currently, Axsome Therapeutics Inc. (Axsome) is developing and testing an oral fixed-dose combination of 45 mg IR DXM with 105 mg SR BUP to achieve therapeutic concentrations of DXM. This investigational drug has been named AXS-05. Axsome has found AXS-05 to be generally safe and well-tolerated in three Phase 1 studies. The adverse event profile of AXS-05 was similar to that of BUP alone.

Given the distinct mechanisms by which BUP and DXM interact, it is hoped that combining DXM and BUP will prove more efficacious than either drug administered alone for the purpose of tobacco use treatment in humans. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03450941
Study type	Interventional
Source	Duke University
Contact	Jillian EH Dirkes, MSW, LCSW
Phone	919-668-5055
Email	jillian.dirkes@duke.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	March 15, 2018
Completion date	January 21, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03999411` - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients	Phase 4
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Completed	`NCT04617444` - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function	N/A
Completed	`NCT02796391` - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes	Phase 2
Completed	`NCT03397511` - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City	N/A
Not yet recruiting	`NCT05188287` - A Culturally Tailored Smartphone Application for African American Smokers	N/A
Recruiting	`NCT05264428` - The Effect of Honey on Lessening the Withdrawal Symptoms	N/A
Recruiting	`NCT05846841` - Personalized Tobacco Treatment in Primary Care (MOTIVATE)	N/A
Completed	`NCT04133064` - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study	N/A
Completed	`NCT03187730` - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants	Phase 4
Completed	`NCT03474783` - To Explore the Factors Affecting the Effectiveness of Smoking Cessation	N/A
Completed	`NCT04635358` - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center	N/A
Terminated	`NCT03670264` - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation	N/A
Not yet recruiting	`NCT06307496` - VIDeOS for Smoking Cessation	N/A
Completed	`NCT02997657` - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial	N/A
Completed	`NCT03206619` - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed	`NCT02905656` - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit	N/A
Completed	`NCT02562521` - A Smoking Cessation Intervention for Yale Dining Employees	Phase 4
Completed	`NCT02239770` - Pharmacokinetics of Nicotine Film in Smokers	N/A
Recruiting	`NCT02422914` - Benefits of Tobacco Free Cigarette	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.