- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05431387
A Study of Cytisinicline for Vaping Cessation in Adult Smokers (ORCA-V1)
February 26, 2024 updated by: Achieve Life Sciences
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adults Using Nicotine-containing E-cigarettes
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40509
- Alliance for Multispecialty Research, LLC
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital - Clinical Genetic Research Facility
-
-
New York
-
Rochester, New York, United States, 14609
- Rochester Clinical Research, Inc
-
-
South Carolina
-
North Charleston, South Carolina, United States, 29405
- Costal Carolina Research Center
-
-
Tennessee
-
Knoxville, Tennessee, United States, 37920
- Alliance for Multispecialty Research, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female subjects, age ≥ 18 years.
- Test positive for cotinine using the Alere iScreen® OFD Cotinine Oral Fluid Screening Device (Positive testing at ≥ 30 ng/mL cotinine level).
- 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.
- Willing to initiate study treatment on the day after randomization and set a quit date within 7-14 days of starting treatment.
- Willing to actively participate in the study's vaping cessation behavioral support provided throughout the study.
- Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
- Sign the Informed Consent Form.
Exclusion Criteria:
- 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).
- Expired carbon monoxide (CO) levels ≥ 10 ppm, indicating recent combustible tobacco use.
- More than 1 study participant in same household during the study treatment period.
- Known hypersensitivity to cytisinicline or any of the excipients.
- 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).
- Clinically significant abnormal serum chemistry or hematology values within 28 days of randomization (i.e., requiring treatment or monitoring).
- 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).
- Recent history (within 3 months) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
- Current uncontrolled hypertension (blood pressure ≥ 160/100 mmHg).
- 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.
- Renal impairment defined as a creatinine clearance (CrCl) < 60 mL/min (estimated with the Cockroft-Gault equation).
- Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.0 x the upper limit of normal (ULN).
- 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.)
- Women who are pregnant or breast-feeding.
- 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.
- Participation in a clinical study with an investigational drug in the 4 weeks prior to study randomization.
- 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.
- 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).
- Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo + Behavioral Support
one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks
|
film-coated oral tablets containing matched placebo
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.
|
Experimental: Cytisinicline + Behavioral Support
one cytisinicline tablet PO TID plus behavioral support for 12 weeks
|
film-coated oral tablets containing 3 mg cytisinicline
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants With Vaping Abstinence During Weeks 9 to 12
Time Frame: Week 9-12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants With Vaping Abstinence During Weeks 3 to 6
Time Frame: Weeks 3-6
|
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
|
Proportion of Participants With Vaping Abstinence During Weeks 6 to 9
Time Frame: Weeks 6-9
|
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
|
Number of Participants Who Achieve Vaping Abstinence at Any Time Between Week 2 and Week 12 (Seven-Day Point Prevalence Rates)
Time Frame: Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 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.
|
Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
Changes From Baseline in Quantitative Cotinine Levels from Week 2 to Week 12
Time Frame: Baseline, Weeks 2-12
|
Changes in nicotine vaping using weekly quantitative cotinine levels from Week 2 to Week 12.
|
Baseline, Weeks 2-12
|
Proportion of Participants With Vaping Abstinence During Weeks 9 to 16
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Daniel Cain, Vice-President Clinical Research, Achieve Life Sciences, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 13, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
February 28, 2023
Study Registration Dates
First Submitted
June 20, 2022
First Submitted That Met QC Criteria
June 20, 2022
First Posted (Actual)
June 24, 2022
Study Record Updates
Last Update Posted (Actual)
February 28, 2024
Last Update Submitted That Met QC Criteria
February 26, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- ACH-CYT-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vaping
-
Philip Morris Products S.A.CompletedNicotine | Nicotine Vaping | VapingUnited Kingdom
-
St. Jude Children's Research HospitalRecruitingVaping | Vaping CessationUnited States
-
University of Massachusetts, WorcesterNational Cancer Institute (NCI)Not yet recruiting
-
University of RochesterNational Cancer Institute (NCI)Completed
-
Philip Morris Products S.A.CompletedNicotine | Nicotine Vaping | VapingUnited States
-
UNC Lineberger Comprehensive Cancer CenterNational Institute on Drug Abuse (NIDA); Food and Drug Administration (FDA)Recruiting
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA)Recruiting
-
UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH); Food and...Completed
-
Mayo ClinicWithdrawn
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States