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NCT04015414
Varenicline Versus Cytisine for Smoking Cessation in Primary Care Setting
Phase 3 trial testing Varenicline in Smoking Cessation in 352 participants. Completed in 1 November 2022.
15 September 2022
Quick facts
| Lead sponsor | University of Zagreb |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 352 |
| Start date | 14 July 2020 |
| Primary completion | 15 September 2022 |
| Estimated completion | 1 November 2022 |
| Sites | 2 locations across Croatia, Slovenia |
Drugs / interventions tested
- Varenicline (varenicline) — full drug profile →
- Cytisine (cytisine) — full drug profile →
Conditions studied
- Smoking Cessation — all drugs for Smoking Cessation →
Sponsor
University of Zagreb
Who can join
18 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overall goals of this study are to 1) assess awareness of interest in the use of pharmacotherapy for smoking cessation in Croatia and Slovenia, countries in Central Europe with very high smoking prevalence, and 2) investigate whether cytisine is at least as feasible and effective as varenicline in helping smokers to quit in a real-life setting: family medicine practices in Croatia and Slovenia. The investigators propose to survey patients from 40 primary care practices (20 in Croatia and 20 in Slovenia) to assess desire to quit smoking and awareness and interest in pharmacotherapy. Additionally, 380 patients with interest in quitting smoking will be randomly assigned to use varenicline or cytisine to help quit smoking. The investigators hypothesize that cytisine is at least as feasible and effective as varenicline in helping smokers from primary care practices in Croatia and Slovenia to quit smoking.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Nicotine receptor partial agonists for smoking cessation.
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, et al · · 2023 · cited 62× · PMID 37142273 · DOI 10.1002/14651858.cd006103.pub8 -
Nicotine receptor partial agonists for smoking cessation
Livingstone-Banks J, Fanshawe T, Thomas K, Theodoulou A, et al · · 2023
Verify or expand the search:
- PubMed search for NCT04015414
- Europe PMC full search
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- NCT06029907 — Project HOPES: Healthy Options for Pain and Ending Smoking. A Program for Cancer Survivors. · Phase 4 · completed
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Other recruiting trials for Smoking Cessation
Currently open trials in the same condition.
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04015414 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Zagreb
- Last refreshed: 3 November 2022
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