CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 254 enrolled
Drug / intervention
Cytisine +2 moredrug
Likely dose
Cytisine 1.5 mgfrom 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.

Search/NCT03709823
NCT03709823Phase 2Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisine in Adult Smokers

Achieve Life Sciences·interventional·Posted Oct 17, 2018·Updated May 18, 2020

In Brief

A Phase 2 clinical trial evaluating Cytisine, Placebo Comparator, and 1 other intervention for Smoking Cessation. Completed, enrolled 254 participants across 8 sites.

Detailed Summary

This placebo-controlled Phase 2b trial is being conducted at sites within the United States (US) to evaluate the effectiveness cytisine dosage (1.5 mg, 3.0 mg) and administration schedule (commercial titration versus simplified 3 times daily \[TID\] schedule) within a 25-day treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 17, 2018
Enrollment StartNov 13, 2018
Primary CompletionApr 23, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.7 years ago

Interventions

Cytisinedrug

film coated tablet containing 1.5 mg cytisine in a single tablet

Placebo Comparatordrug

1.5 mg cellulose powder to match final weight of the cytisine tablet

Behavioral supportbehavioral

12 behavioral support sessions by a qualified staff member plus supportive literature and online resources