Trial · NCT05206370
A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers
NCT05206370, Phase 3, Completed, Achieve Life Sciences; results first posted 2026-01-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers. Trials, record NCT05206370. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05206370
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Second Study of Cytisinicline for Smoking Cessation in Adult Smokers
- NCT number
- NCT05206370
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 792 participants, actual
- Lead sponsor
- Achieve Life Sciences
- Conditions
- Smoking Cessation
- Interventions
- Cytisinicline, Placebo, Behavioral support
- First posted
- 2022-01-25
- Last updated
- 2026-01-14
- Results first posted
- 2026-01-14
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6 | Weeks 3 to 6 | Smoking abstinence as verified by weekly expired carbon monoxide (CO) measurements ≤ 10 parts per million (ppm). |
| Primary | Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12 | Weeks 9 to 12 | Smoking abstinence as verified by weekly expired CO measurements ≤ 10 ppm. |
| Secondary | Percentage of Participants With Continuous Smoking Abstinence From Week 3 to Week 24 | Week 3 to Week 24 | Smoking abstinence as verified by expired CO measurements ≤ 10 ppm. Measurements were weekly from Week 3 to Week 12 and monthly from Week 12 to Week 24. |
| Secondary | Percentage of Participants With Continuous Smoking Abstinence From Week 9 to Week 24 | Week 9 to Week 24 | Smoking abstinence as verified by expired CO measurements ≤ 10 ppm. Measurements were weekly from Week 9 to Week 12 and monthly from Week 12 to Week 24. |
| Secondary | Percentage of Participants Taking Cytisinicline Who Are Relapse-Free at Week 24 | Week 24 | Relapse is defined as participant reported resuming smoking or an expired CO measure ≥ 10 ppm. Relapse is defined as a participant having met one of the following: not being abstinent from Weeks 3 to 6; not being abstinent at the Week 12 visit; not being abstinent or not self-reporting abstinence during the Week 16 to Week 24 follow-up period. (During the follow-up period \[Weeks 16 to 24\], up to a total of 5 cigarettes could have been smoked.) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6 | Weeks 3 to 6 | All Randomized Set: all randomized participants. Placebo and 6-week treatment arms only. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12 | Weeks 9 to 12 | All Randomized Set: all randomized participants, Placebo and 12-week treatment arms only. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Smoking Abstinence From Week 3 to Week 24 | Week 3 to Week 24 | All Randomized Set: all randomized participants, Placebo and 6-week treatment arms only. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Continuous Smoking Abstinence From Week 9 to Week 24 | Week 9 to Week 24 | All Randomized Set: all randomized participants, Placebo and 12-week treatment arms only. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Taking Cytisinicline Who Are Relapse-Free at Week 24 | Week 24 | All Randomized Set: All randomized participants. Participants in the cytisinicline arms. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6 | Placebo + Behavioral Support | 6.0 | percentage of participants | ||
| Percentage of Participants With Smoking Abstinence From Weeks 3 to Week 6 | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 14.8 | percentage of participants | ||
| Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12 | Placebo + Behavioral Support | 9.4 | percentage of participants | ||
| Percentage of Participants With Smoking Abstinence From Weeks 9 to Week 12 | 12-Week Cytisinicline + Behavioral Support | 30.3 | percentage of participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 3 to Week 24 | Placebo + Behavioral Support | 1.1 | percentage of participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 3 to Week 24 | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 6.8 | percentage of participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 9 to Week 24 | Placebo + Behavioral Support | 4.2 | percentage of participants | ||
| Percentage of Participants With Continuous Smoking Abstinence From Week 9 to Week 24 | Cytisinicline + Behavioral Support | 20.5 | percentage of participants | ||
| Percentage of Participants Taking Cytisinicline Who Are Relapse-Free at Week 24 | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 8.7 | percentage of participants | ||
| Percentage of Participants Taking Cytisinicline Who Are Relapse-Free at Week 24 | 12-Week Cytisinicline + Behavioral Support | 10.6 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo + Behavioral Support | 265 | |
| Overall Study | STARTED | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 263 | |
| Overall Study | STARTED | 12-Week Cytisinicline + Behavioral Support | 264 | |
| Overall Study | COMPLETED | Placebo + Behavioral Support | 209 | |
| Overall Study | COMPLETED | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 207 | |
| Overall Study | COMPLETED | 12-Week Cytisinicline + Behavioral Support | 212 | |
| Overall Study | NOT COMPLETED | Placebo + Behavioral Support | 56 | |
| Overall Study | NOT COMPLETED | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 56 | |
| Overall Study | NOT COMPLETED | 12-Week Cytisinicline + Behavioral Support | 52 |
Source ClinicalTrials.gov
Adverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo + Behavioral Support | 3 | 262 | |
| other | Constipation | Gastrointestinal disorders | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 7 | 263 | |
| other | Constipation | Gastrointestinal disorders | 12-Week Cytisinicline + Behavioral Support | 6 | 260 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo + Behavioral Support | 12 | 262 | |
| other | Diarrhoea | Gastrointestinal disorders | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 12 | 263 | |
| other | Diarrhoea | Gastrointestinal disorders | 12-Week Cytisinicline + Behavioral Support | 8 | 260 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo + Behavioral Support | 6 | 262 | |
| other | Dry mouth | Gastrointestinal disorders | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 12 | 263 | |
| other | Dry mouth | Gastrointestinal disorders | 12-Week Cytisinicline + Behavioral Support | 6 | 260 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo + Behavioral Support | 2 | 262 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + Behavioral Support | 0 | 262 |
| Total, all-cause mortality | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 1 | 263 |
| Total, all-cause mortality | 12-Week Cytisinicline + Behavioral Support | 3 | 260 |
| Total, other adverse events | Placebo + Behavioral Support | 110 | 262 |
| Total, other adverse events | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 132 | 263 |
| Total, other adverse events | 12-Week Cytisinicline + Behavioral Support | 137 | 260 |
| Total, serious adverse events | Placebo + Behavioral Support | 8 | 262 |
| Total, serious adverse events | 6-Week Cytisinicline + 6-Week Placebo + Behavioral Support | 8 | 263 |
| Total, serious adverse events | 12-Week Cytisinicline + Behavioral Support | 8 | 260 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05206370
GET https://conductscience.org/api/trials/v1/NCT05206370/events?page=2