A Study of Cytisinicline for Vaping Cessation in Adult Smokers

Vaping Clinical Trial

— ORCA-V1  

Official title:

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adults Using Nicotine-containing E-cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05431387
• Other study ID #: ACH-CYT-10
• Status: Completed
• Phase: Phase 2
• Start date: July 13, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: February 2024
• Source: Achieve Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the safety profile of 3 mg cytisinicline administered TID for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects, age = 18 years.

2. Test positive for cotinine using the Alere iScreen® OFD Cotinine Oral Fluid Screening Device (Positive testing at = 30 ng/mL cotinine level).

3. Current daily nicotine-containing electronic cigarette usage as recorded in a screening diary for at least 7 consecutive days. Willing to bring the e-cigarette or nicotine device used to the clinical site so that the specific product type, flavor, and nicotine level can be documented.

4. Willing to initiate study treatment on the day after randomization and set a quit date within 7-14 days of starting treatment.

5. Willing to actively participate in the study's vaping cessation behavioral support provided throughout the study.

6. Able to fully understand study requirements, willing to participate, and comply with dosing schedule.

7. Sign the Informed Consent Form.

Exclusion Criteria:

1. Currently smoking, or having smoked within 4 weeks prior to study randomization, any combustible cigarettes, other combustible tobacco products or non-combustible tobacco products (such as heat not burn products) (i.e., dual users).

2. Expired carbon monoxide (CO) levels = 10 ppm, indicating recent combustible tobacco use.

3. More than 1 study participant in same household during the study treatment period.

4. Known hypersensitivity to cytisinicline or any of the excipients.

5. Positive urinary drugs of abuse screen determined within 28 days before the first dose of cytisinicline (Note: tetrahydrocannabinol (THC) is not part of the abuse screen).

6. Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e., requiring treatment or monitoring).

7. Clinically significant abnormalities in 12-lead electrocardiogram determined after minimum of 5 minutes in supine position within 28 days of randomization (i.e., requiring treatment or further assessment).

8. Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.

9. Current uncontrolled hypertension (blood pressure = 160/100 mmHg).

10. Documented diagnosis of schizophrenia or bipolar psychiatric illness; currently psychotic; having suicidal ideation within the last 3 months (corresponding to question 4 or 5 on the Columbia - Suicide Severity Rating Scale [C-SSRS]); or current symptoms of moderate to severe depression (depression score = 11 on the HADS) within the last 3 months.

11. Renal impairment defined as a creatinine clearance (CrCl) < 60 mL/min (estimated with the Cockroft-Gault equation).

12. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 x the upper limit of normal (ULN).

13. Recent history or symptoms (within 4 weeks of randomization) of unstable respiratory disease (e.g., pneumonia, product-use associated lung injury or e-cigarette or vaping use-associated lung injury [EVALI], etc.)

14. Women who are pregnant or breast-feeding.

15. Male or female subjects of childbearing potential who do not agree to use acceptable methods of birth control starting at the time of consent, during the study treatment period, and continuing for one month after ending study treatment.

16. Participation in a clinical study with an investigational drug in the 4 weeks prior to study randomization.

17. Use of other smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy [NRT]) in the 4 weeks prior to study randomization, any previous cytisine use, or planned use of these or other nicotine replacement medications during the study.

18. Any planned use during the study of combustible cigarettes or other nicotine-containing, non-vaping products (e.g., pipe tobacco, cigars, snuff, smokeless tobacco, hookah, ZYN pouches, etc).

19. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.

Related Conditions & MeSH terms

• E-Cig Use
• Vaping

Intervention

Drug:
• cytisinicline
film-coated oral tablets containing 3 mg cytisinicline
• Placebo
film-coated oral tablets containing matched placebo

Behavioral:
• Behavioral support
Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the participant about their attempt to quit vaping. Each session will last approximately 10 minutes.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital - Clinical Genetic Research Facility	Boston	Massachusetts
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Alliance for Multispecialty Research, LLC	Lexington	Kentucky
United States	Costal Carolina Research Center	North Charleston	South Carolina
United States	Rochester Clinical Research, Inc	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Achieve Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Vaping Abstinence During Weeks 9 to 12	Vaping abstinence using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping in the past 7 days.	Week 9-12
Secondary	Proportion of Participants With Vaping Abstinence During Weeks 3 to 6	Vaping abstinence using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping in the past 7 days.	Weeks 3-6
Secondary	Proportion of Participants With Vaping Abstinence During Weeks 6 to 9	Vaping abstinence using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping in the past 7 days.	Weeks 6-9
Secondary	Number of Participants Who Achieve Vaping Abstinence at Any Time Between Week 2 and Week 12 (Seven-Day Point Prevalence Rates)	Vaping abstinence using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping in the past 7 days.	Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary	Changes From Baseline in Quantitative Cotinine Levels from Week 2 to Week 12	Changes in nicotine vaping using weekly quantitative cotinine levels from Week 2 to Week 12.	Baseline, Weeks 2-12
Secondary	Proportion of Participants With Vaping Abstinence During Weeks 9 to 16	Vaping abstinence using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping in the past 7 days.	Weeks 9 to 16