Trials / Completed
CompletedNCT03709823
Trial of Cytisine in Adult Smokers
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisine in Adult Smokers
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 254 (actual)
- Sponsor
- Achieve Life Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cytisine | film coated tablet containing 1.5 mg cytisine in a single tablet |
| DRUG | Placebo Comparator | 1.5 mg cellulose powder to match final weight of the cytisine tablet |
| BEHAVIORAL | Behavioral support | 12 behavioral support sessions by a qualified staff member plus supportive literature and online resources |
Timeline
- Start date
- 2018-11-13
- Primary completion
- 2019-04-23
- Completion
- 2019-04-23
- First posted
- 2018-10-17
- Last updated
- 2020-05-18
- Results posted
- 2020-05-18
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03709823. Inclusion in this directory is not an endorsement.