At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 74 enrolled
Drug / intervention
cytisine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate the Tolerability and Safety of Cytisine in Adult Smokers
In Brief
A Phase 1 clinical trial evaluating cytisine and placebo for Smoking Cessation. Completed, enrolled 74 participants across 1 site.
Detailed Summary
The objectives of this study are: 1. To assess the tolerability and safety of cytisine as a single oral dose. 2. To define the Cmax levels associated to the occurrence of dose-limiting adverse events.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesPortugal
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 2019
Enrollment StartFeb 2019
Primary CompletionSep 2019
TodayJul 2026
First PostedFeb 20, 2019
Enrollment StartFeb 28, 2019
Primary CompletionSep 12, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.4 years ago
Interventions
cytisinedrug
cytisine film-coated oral tablet
placebodrug
matching placebo oral tablet