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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Behavioral Support | Placebo Comparator | one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks |
|
| Cytisinicline + Behavioral Support | Experimental | one cytisinicline tablet PO TID plus behavioral support for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cytisinicline | Drug | film-coated oral tablets containing 3 mg cytisinicline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 9 to 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 3 to 6 |
| Percentage of Participants With Vaping Abstinence From Week 6 to 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Cain, Vice-President Clinical Research | Achieve Life Sciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC | Lexington | Kentucky | 40509 | United States | ||
| Massachusetts General Hospital - Clinical Genetic Research Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38709500 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Behavioral Support | one placebo tablet orally (PO) three times daily (TID) plus behavioral support for 12 weeks |
| FG001 | Cytisinicline + Behavioral Support | one cytisinicline tablet PO TID plus behavioral support for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Behavioral Support | one placebo tablet PO TID plus behavioral support for 12 weeks |
| BG001 | Cytisinicline + Behavioral Support | one cytisinicline tablet PO TID plus behavioral support for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants | Posted | Number | percentage of participants | Weeks 9 to 12 |
|
up to Week 16 ±3 days
Safety Set; all treated participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + Behavioral Support | one placebo tablet PO TID plus behavioral support for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Ball, Vice President, Clinical Operations | Achieve Life Sciences | 425-686-1540 | jball@achievelifesciences.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2022 | Oct 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2023 | Oct 30, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C004712 | cytisine |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Placebo | Drug | film-coated oral tablets containing matched placebo |
|
| Behavioral support | Behavioral | 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. |
|
Vaping abstinence verified weekly using quantitative saliva cotinine levels at < 10 ng/mL for biochemical verification and participants' self-report of no vaping. |
| 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. | 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. | 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. | Weeks 9 to 16 |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37920 | United States |
| Physician Decision |
|
| Lost to Follow-up |
|
| Other, Not Specified |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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. | All randomized participants | Posted | Number | percentage of participants | Weeks 3 to 6 |
|
|
|
|
| Secondary | 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. | All randomized participants | Posted | Number | percentage of participants | Weeks 6 to 9 |
|
|
|
|
| Secondary | 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. | All randomized participants | Posted | Number | percentage of participants | 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 measured by weekly quantitative cotinine levels from Week 2 to Week 12. | All randomized participants with an assessment at given time point | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline, Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
|
|
|
|
| Secondary | 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. | All randomized participants | Posted | Number | percentage of participants | Weeks 9 to 16 |
|
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 26 |
| 53 |
| EG001 | Cytisinicline + Behavioral Support | one cytisinicline tablet PO TID plus behavioral support for 12 weeks | 0 | 106 | 0 | 106 | 42 | 106 |
| Nausea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
|
Principal Investigators are bound by requirements outlined in their individual clinical trial agreements with regard to publication of trial results.
| Difference in proportions |
| 0.09 |
| 2-Sided |
| 95 |
| -0.058 |
| 0.209 |
| Superiority |
| Difference in proportions |
| 0.14 |
| 2-Sided |
| 95 |
| -0.019 |
| 0.263 |
| Superiority |
| Week 4 |
|
| Week 5 |
|
| Week 6 |
|
| Week 7 |
|
| Week 8 |
|
| Week 9 |
|
| Week 10 |
|
| Week 11 |
|
| Week 12 |
|
| Exact computations |
| 0.3038 |
Two-sided, derived from marginal odds ratio. |
| Difference in proportions |
| 0.06 |
| 2-Sided |
| 95 |
| -0.058 |
| 0.144 |
| Superiority |
| Week 3 | Exact computations | 0.1996 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 1.73 | 2-Sided | 95 | 0.817 | 3.800 | Superiority |
| Week 3 | Exact computations | 0.1996 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.11 | 2-Sided | 95 | -0.055 | 0.251 | Superiority |
| Week 4 | Exact computations | 0.0035 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 3.02 | 2-Sided | 95 | 1.458 | 6.414 | Superiority |
| Week 4 | Exact computations | 0.0035 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.25 | 2-Sided | 95 | 0.078 | 0.395 | Superiority |
| Week 5 | Exact computations | 0.1183 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 1.84 | 2-Sided | 95 | 0.905 | 3.809 | Superiority |
| Week 5 | Exact computations | 0.1183 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.14 | 2-Sided | 95 | -0.035 | 0.290 | Superiority |
| Week 6 | Exact computations | 0.0532 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 2.15 | 2-Sided | 95 | 1.035 | 4.585 | Superiority |
| Week 6 | Exact computations | 0.0532 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.17 | 2-Sided | 95 | -0.004 | 0.311 | Superiority |
| Week 7 | Exact computations | 0.0019 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 3.23 | 2-Sided | 95 | 1.539 | 6.989 | Superiority |
| Week 7 | Exact computations | 0.0019 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.26 | 2-Sided | 95 | 0.089 | 0.400 | Superiority |
| Week 8 | Exact computations | 0.0246 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 2.32 | 2-Sided | 95 | 1.119 | 4.944 | Superiority |
| Week 8 | Exact computations | 0.0246 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.18 | 2-Sided | 95 | 0.014 | 0.330 | Superiority |
| Week 9 | Exact computations | 0.0362 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 2.23 | 2-Sided | 95 | 1.076 | 4.762 | Superiority |
| Week 9 | Exact computations | 0.0362 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.18 | 2-Sided | 95 | 0.005 | 0.321 | Superiority |
| Week 10 | Exact computations | 0.1215 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 1.77 | 2-Sided | 95 | 0.871 | 3.668 | Superiority |
| Week 10 | Exact computations | 0.1215 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.13 | 2-Sided | 95 | -0.044 | 0.281 | Superiority |
| Week 11 | Exact computations | 0.1123 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 1.84 | 2-Sided | 95 | 0.882 | 3.935 | Superiority |
| Week 11 | Exact computations | 0.1123 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.13 | 2-Sided | 95 | -0.040 | 0.274 | Superiority |
| Week 12 | Exact computations | 0.0516 | Two-sided, derived from marginal (unadjusted) odds ratio. | Odds Ratio (OR) | 2.12 | 2-Sided | 95 | 1.006 | 4.626 | Superiority |
| Week 12 | Exact computations | 0.0516 | Two-sided, derived from marginal odds ratio. | Difference in proportions | 0.16 | 2-Sided | 95 | -0.011 | 0.298 | Superiority |
| Change at Week 3 |
|
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| Change at Week 4 |
|
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| Change at Week 5 |
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| Change at Week 6 |
|
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| Change at Week 7 |
|
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| Change at Week 8 |
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| Change at Week 9 |
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| Change at Week 10 |
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| Change at Week 11 |
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| Change at Week 12 |
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|
Change at Week 3 |
| Compound symmetry covariance matrix |
| 1.0000 |
A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. |
| LS means difference |
| -72.832 |
| Standard Error of the Mean |
| 32.6388 |
| 2-Sided |
| 95 |
| -195.3491 |
| 49.6842 |
| Superiority |
| Change at Week 4 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -74.090 | Standard Error of the Mean | 32.8018 | 2-Sided | 95 | -197.2184 | 49.0381 | Superiority |
| Change at Week 5 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -83.364 | Standard Error of the Mean | 32.7865 | 2-Sided | 95 | -206.4354 | 39.7066 | Superiority |
| Change at Week 6 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -79.952 | Standard Error of the Mean | 32.9139 | 2-Sided | 95 | -203.5009 | 43.5976 | Superiority |
| Change at Week 7 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -49.309 | Standard Error of the Mean | 33.2714 | 2-Sided | 95 | -174.2006 | 75.5817 | Superiority |
| Change at Week 8 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -78.107 | Standard Error of the Mean | 33.2237 | 2-Sided | 95 | -202.8196 | 46.6046 | Superiority |
| Change at Week 9 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -86.006 | Standard Error of the Mean | 33.5025 | 2-Sided | 95 | -211.7643 | 39.7529 | Superiority |
| Change at Week 10 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -62.680 | Standard Error of the Mean | 33.1510 | 2-Sided | 95 | -187.1187 | 61.7592 | Superiority |
| Change at Week 11 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -63.262 | Standard Error of the Mean | 33.2292 | 2-Sided | 95 | -187.9952 | 61.4704 | Superiority |
| Change at Week 12 | Compound symmetry covariance matrix | 1.0000 | A compound symmetry covariance matrix was used. Bonferroni adjusted p-values are reported. | LS means difference | -57.329 | Standard Error of the Mean | 33.2475 | 2-Sided | 95 | -182.1302 | 67.4727 | Superiority |
| 0.1470 |
Two-sided, derived from marginal odds ratio. |
| Difference in proportions |
| 0.10 |
| 2-Sided |
| 95 |
| -0.044 |
| 0.211 |
| Superiority |