Smoking Cessation Clinical Trial
Official title:
A Randomized, Double-Blind 4-Week Study to Evaluate the Impact of AXS-05 on Smoking Behavior
Verified date | December 2022 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study is designed with the purpose of evaluating a new drug, combination Dextromethorphan-Bupropion (AXS-05), for its effects on smoking behavior.
Status | Completed |
Enrollment | 58 |
Est. completion date | March 31, 2019 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: 1. Age 18 years or above 2. Daily smoker using 10 or more cigarettes per day 3. Willing to be smoke-free for 7 days 4. Is able to provide written informed consent (in English) to participate in the study and able to understand the procedures and study requirements. 5. 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: 1. Current use of a smoking cessation medication (e.g. nicotine replacement, Varenicline, bupropion) 2. Current use of tobacco product other than cigarettes (e.g. e-cigarettes, smokeless tobacco) 3. Not pregnant or breastfeeding 4. Contraindication to the use of bupropion. 5. Additional criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Duke Center for Smoking Cessation | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
James Davis | Axsome Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Smoking Intensity | Smoking intensity refers to the number of cigarettes smoked per day. | Baseline (V1), 3-Week Follow-Up Visit (V4) | |
Primary | 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 | Change in Smoking Behavior | 7-day point prevalence smoking abstinence. Measured by composite self-report diaries and biochemically confirmed via expired CO and salivary cotinine. | 3-Week Follow-Up Visit (V4), 4-Week Follow-Up Visit (V5) | |
Secondary | Medication Adherence | Medication adherence is measured by composite self-reported diaries. | Baseline (V1), 3-Week Follow-Up Visit (V4) | |
Secondary | Medication Tolerance by Self-Reported Side Effects | 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). | Baseline (V1), 3-Week Follow-Up Visit (V4) | |
Secondary | Medication Tolerance by Serious Adverse Events | Measured by FDA reporting guidelines on adverse event or serious adverse event designation. | Baseline (V1), 4-Week Follow-Up Visit (V5) | |
Secondary | Urinary Levels of Dextromethorphan | Measured via Urinary Dextromethorphan testing. | 3-Week Follow-Up Visit (V4) |
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