Vaping CessationPhase 3ORCA-V2NCT07392125
Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes
A Phase 3 study testing Cytisinicline and Behavioral Support in people with Vaping Cessation, run by Achieve Life Sciences.
Trial summary
This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only. A total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms: Arm B, 12 weeks cytisinicline + behavior support: N=400 or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaping Cessation
- What is being tested?
- Cytisinicline and Behavioral Support
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, age ≥18 years.
- Test positive for cotinine using a point-of-care Oral Fluid Screening Device (OFD) with positive detection at ≥30 ng/mL cotinine.
- 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.
- Failed at least one previous attempt to stop vaping with or without therapeutic support.
- Willing to initiate study treatment on the day after randomization and set a quit date within Day 7 and Day 14.
- 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.
Who cannot join
- Currently smoking or having smoked within 3 months prior to study randomization, any combustible cigarettes, other combustible tobacco products or non-combustible tobacco products such as heat not burn products or nicotine pouches (ie, dual users).
- Currently smoking/vaping cannabis or having smoked or vaped cannabis within 4 weeks (28 days) prior to study randomization or planned use while on study. Other methods of cannabis consumption, eg, edibles, tinctures, capsules, topicals, etc. are allowed.
- Expired Carbon Monoxide (CO) levels ≥6 ppm, indicating recent combustible tobacco or cannabis smoking.
- A score of 0-3 on the Penn State e-Cigarette Dependence Index indicating no dependence.
- More than 1 study subject in same household during the study treatment period.
- Known hypersensitivity to any of the excipients, previous cytisinicline treatment in a prior clinical study, or any previous use of cytisinicline.
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- Positive urinary drugs of abuse screen determined within 28 days before the first dose of study drug. (Note: Although THC is part of the standard drug screen, it is not necessarily exclusionary. Refer to exclusion criteria #2).
- Clinically significant abnormal serum chemistry or hematology values, as determined by the investigator, within 28 days of randomization.
- Clinically significant abnormalities on screening visit 12-lead ECG, as determined by the investigator, after minimum of 5 minutes in supine position within 28 days of randomization.
- Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
- Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
- Currently psychotic or having had a psychotic event in the 3 months prior to the screening visit. If any subject becomes psychotic during the study, they must be removed from treatment and/or additional study visits.
- Currently having suicidal ideation or risk for suicide (YES to either question 3, 4 or 5 OR YES to any suicidal behavior question on the C-SSRS with clear suicidal intent or suicide attempt within the last 10 years).
- Current symptoms of moderate to severe depression (depression score ≥11 using depression questions on the Hospital Anxiety and Depression Scale [HADS] at screening visit).
- Renal impairment defined as a creatinine clearance (CrCl) <60 mL/min at screening visit (estimated with the Cockroft-Gault equation and reported by the central laboratory).
- Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN) at screening visit.
- Recent history or symptoms (within 4 weeks of randomization) of unstable respiratory disease (eg, pneumonia, product-use associated lung injury or EVALI, etc).
- Women who are pregnant or breast-feeding.
- Female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study. Acceptable methods of birth control include:
- True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- Barrier methods:
- diaphragm
- cervical cap
- contraceptive sponge
- intrauterine device (IUD)
- double barrier method (condom with spermicide)
- Hormonal methods:
- Oral contraceptives
- Vaginal ring such as NuvaRing
- Skin patch such as Xulane
- Injection such as Depro-Provera
- Implantable rod such as Nexplanon
- Intrauterine device (IUD)
- Participation in a clinical study with an investigational drug or biologic in the 4 weeks prior to study randomization.
- Use of any smoking cessation medications (bupropion, varenicline, nortriptyline, or any nicotine replacement therapy [NRT]) in the 4 weeks prior to study randomization 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 (eg, 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes
This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only.
A total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms:
- Arm B, 12 weeks cytisinicline + behavior support: N=400 or
- Arm A, 12 weeks of placebo+ behavior support: N=400) The primary objective is to assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support).
- Conditions
- Vaping Cessation
- Being tested
- Cytisinicline, Placebo, Behavioral Support
- Keywords
- vaping cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytisiniclineDrug
Also called cytisine
Tablet, 3 times a day (TID), 12 weeks
PlaceboDrug
Tablet, 3 times a day (TID), 12 weeks
Behavioral SupportBehavioural
16 behavioral support sessions, starting prior to randomization and through Week 12, 3 additional sessions during the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Placebo comparator | 12 weeks of placebo + behavioral support; 400 subjects Receives: Drug: Placebo; Behavioral: Behavioral Support |
| Arm B | Active comparator | 12 weeks cytisinicline + behavioral support; 400 subjects Receives: Drug: Cytisinicline; Behavioral: Behavioral Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Objective
Assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 post-randomization as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support). Successful vaping cessation is defined as weekly vaping abstinence during the last 4 weeks of the 12-week treatment period (Week 9 through Week 12) using quantitative cotinine levels at <10 ng/mL for biochemical verification and subject's self-report of no vaping using a daily electronic diary
Measured: Randomization to Week 24 follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaping CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julie Ball, Study director, Achieve Life Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392125
- Sponsor's protocol ID
- ACH-CYT-12
- Acronym
- ORCA-V2
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline for Vaping Cessation in Adults Using Nicotine-Containing E Cigarettes
- ClinicalTrials.gov ID
- NCT07392125
- Acronym / sponsor ID
- ORCA-V2 / ACH-CYT-12
- Conditions
- Vaping Cessation
- Keywords
- vaping cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a multi-center, double-blind, randomized, placebo-controlled, Phase 3 study conducted in male or female adults who are daily nicotine e-cigarette users only.
A total of approximately 800 subjects will be randomly assigned (1:1) to one of two Arms:
- Arm B, 12 weeks cytisinicline + behavior support: N=400 or
- Arm A, 12 weeks of placebo+ behavior support: N=400) The primary objective is to assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Placebo comparator | Drug: Placebo, Behavioral: Behavioral Support12 weeks of placebo + behavioral support; 400 subjects |
| Arm B | Active comparator | Drug: Cytisinicline, Behavioral: Behavioral Support12 weeks cytisinicline + behavioral support; 400 subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects, age ≥18 years.
- Test positive for cotinine using a point-of-care Oral Fluid Screening Device (OFD) with positive detection at ≥30 ng/mL cotinine.
- 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.
- Failed at least one previous attempt to stop vaping with or without therapeutic support.
- Willing to initiate study treatment on the day after randomization and set a quit date within Day 7 and Day 14.
Key exclusion criteria (37 listed)
- Currently smoking or having smoked within 3 months prior to study randomization, any combustible cigarettes, other combustible tobacco products or non-combustible tobacco products such as heat not burn products or nicotine pouches (ie, dual users).
- Currently smoking/vaping cannabis or having smoked or vaped cannabis within 4 weeks (28 days) prior to study randomization or planned use while on study. Other methods of cannabis consumption, eg, edibles, tinctures, capsules, topicals, etc. are allowed.
- Expired Carbon Monoxide (CO) levels ≥6 ppm, indicating recent combustible tobacco or cannabis smoking.
- A score of 0-3 on the Penn State e-Cigarette Dependence Index indicating no dependence.
- More than 1 study subject in same household during the study treatment period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytisiniclineAlso: cytisineTablet, 3 times a day (TID), 12 weeks | Drug | Arm B |
| PlaceboTablet, 3 times a day (TID), 12 weeks | Drug | Arm A |
| Behavioral Support16 behavioral support sessions, starting prior to randomization and through Week 12, 3 additional sessions during the follow-up period. | Behavioural | Arm A, Arm B |
Primary outcome
Primary Efficacy Objective
Time frame: Randomization to Week 24 follow-up visit
Assess whether subjects randomized to Arm B (3 mg cytisinicline TID for 12 weeks plus behavioral support) have a higher probability of nicotine vaping cessation from Week 9 to Week 12 post-randomization as compared to subjects randomized to Arm A (placebo TID for 12 weeks plus behavioral support). Successful vaping cessation is defined as weekly vaping abstinence during the last 4 weeks of the 12-week treatment period (Week 9 through Week 12) using quantitative cotinine levels at <10 ng/mL for biochemical verification and subject's self-report of no vaping using a daily electronic diary
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Ball study director
Achieve Life Sciences, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cytisinicline and Behavioral Support in people with Vaping Cessation, run by Achieve Life Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Ball; Vice President, Clinical Operations (425-686-1540, jball@achievelifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Objective (time frame: Randomization to Week 24 follow-up visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.