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Trial of Cytisine in Adult Smokers

NCT03709823 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2020-05-18

Study results available
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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

  • Smoking Cessation

Interventions

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

Sponsors & Collaborators

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Mitchell Nides, PhD · Los Angeles Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2019-04-23
Completion
2019-04-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709823 on ClinicalTrials.gov