VapingPhase 2ORCA-V1NCT05431387
A Study of Cytisinicline for Vaping Cessation in Adult Smokers
A Phase 2 study testing cytisinicline and Behavioral support in people with Vaping and E-Cig Use, run by Achieve Life Sciences at 5 sites in United States.
Trial summary
This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the efficacy and safety profile of 3 mg cytisinicline administered TID for 12 weeks for vaping cessation. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 160 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Jul 2022to 28 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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 cytisinicline 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital - Clinical Genetic Research Facility
Boston, Massachusetts, 02114
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37920
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Rochester Clinical Research, Inc
Rochester, New York, 14609
About this study
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
This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the efficacy and safety profile of 3 mg cytisinicline administered TID for 12 weeks for vaping cessation.
- Being tested
- cytisinicline, Placebo, Behavioral support
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytisiniclineDrug
Also called cytisine
film-coated oral tablets containing 3 mg cytisinicline
PlaceboDrug
film-coated oral tablets containing matched placebo
Behavioral supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Behavioral Support | Placebo comparator | one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks Receives: Drug: Placebo; Behavioral: Behavioral support |
| Cytisinicline + Behavioral Support | Experimental | one cytisinicline tablet PO TID plus behavioral support for 12 weeks Receives: Drug: cytisinicline; Behavioral: Behavioral support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Vaping Abstinence From Week 9 to 12
Vaping abstinence verified weekly using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Measured: Weeks 9 to 12
Secondary outcomes (5)
Percentage of Participants With Vaping Abstinence From Week 3 to 6
Vaping abstinence verified weekly using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Measured: Weeks 3 to 6
Percentage of Participants With Vaping Abstinence From Week 6 to 9
Vaping abstinence verified weekly using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping.
Measured: Weeks 6 to 9
Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates)
The 7-day point prevalence abstinence endpoints are binary (success, failure), defined at each of the following visits: Week 2 to Week 12. Vaping abstinence used quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping in the past 7 days.
Measured: 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
Changes in nicotine vaping measured by weekly quantitative cotinine levels from Week 2 to Week 12.
Measured: Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percentage of Participants With Vaping Abstinence From Week 9 to 16
Vaping abstinence used quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping. Measurements were Weekly from Week 9 to 12 and one month for Week 16.
Measured: Weeks 9 to 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start13 Jul 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VapingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Cain, Vice-President Clinical Research, Study director, Achieve Life Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431387
- Sponsor's protocol ID
- ACH-CYT-10
- Acronym
- ORCA-V1
- Status last verified
- Dec 2025
- First submitted
- 20 Jun 2022
- Last updated
- 14 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rigotti NA, Benowitz NL, Prochaska JJ, Cain DF, Ball J, Clarke A, Blumenstein BA, Jacobs C. Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial. JAMA Intern Med. 2024 Aug 1;184(8):922-930. doi: 10.1001/jamainternmed.2024.1313.
PubMed 38709500
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05431387
- Acronym / sponsor ID
- ORCA-V1 / ACH-CYT-10
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 24 Jun 2022 (actual)
- Results
- Posted 14 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This placebo-controlled Phase 2 study is being conducted at sites within the United States to evaluate the efficacy and safety profile of 3 mg cytisinicline administered TID for 12 weeks for vaping cessation.
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 |
|---|---|---|
| Placebo + Behavioral Support | Placebo comparator | Drug: Placebo, Behavioral: Behavioral supportone placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks |
| Cytisinicline + Behavioral Support | Experimental | Drug: cytisinicline, Behavioral: Behavioral supportone cytisinicline tablet PO TID plus behavioral support for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
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: cytisinefilm-coated oral tablets containing 3 mg cytisinicline | Drug | Cytisinicline + Behavioral Support |
| Placebofilm-coated oral tablets containing matched placebo | Drug | Placebo + Behavioral Support |
| Behavioral supportBehavioral 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. | Behavioural | Cytisinicline + Behavioral Support, Placebo + Behavioral Support |
Primary outcome
Percentage of Participants With Vaping Abstinence From Week 9 to 12
Time frame: Weeks 9 to 12
Vaping abstinence verified weekly using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping.
5 secondary outcomes
Percentage of Participants With Vaping Abstinence From Week 3 to 6
Time frame: Weeks 3 to 6
Percentage of Participants With Vaping Abstinence From Week 6 to 9
Time frame: Weeks 6 to 9
Percentage of Participants Who Achieve Vaping Abstinence at Each Visit From Week 2 and Week 12 (Seven-Day Point Prevalence Rates)
Time frame: 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, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Percentage of Participants With Vaping Abstinence From Week 9 to 16
Time frame: Weeks 9 to 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38709500Rigotti NA, Benowitz NL, Prochaska JJ, Cain DF, Ball J, Clarke A, Blumenstein BA, Jacobs C. Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial. JAMA Intern Med. 2024 Aug 1;184(8):922-930. doi: 10.1001/jamainternmed.2024.1313.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Daniel Cain, Vice-President Clinical Research study director
Achieve Life Sciences, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cytisinicline and Behavioral support in people with Vaping and E-Cig Use, run by Achieve Life Sciences at 5 sites in United States.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Vaping Abstinence From Week 9 to 12 (time frame: Weeks 9 to 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431387, which also lists 1 linked publication.
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 14 Jan 2026.