NCT02401022

The Study of AZD8529 for Smoking Cessation in Female Smokers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.

Detailed description

This is a 19-week, multi-center, randomized, Phase 2 clinical study comparing the efficacy of two different doses of AZD8529 (1.5 and 40 mg) in smoking cessation. Up to 2 weeks will be allowed for the Screening Period, followed by a 1-week, single-blind run-in period. At the end of Study Week 1 (on Study Day 8), medication compliance will be one of the factors used in a predictive enrichment strategy.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	AZD8529	comparison of different dosages of drug

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-11-01
• Completion: 2017-01-01
• First posted: 2015-03-27
• Last updated: 2017-11-29
• Results posted: 2017-11-29

Locations

9 sites across 1 country: United States