Conditions: Tobacco Use Disorder
Keywords: smoking smoking cessation cigarette
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 214
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: 1.5 mg arm 2: 40mg

Interventions: intervention 1: AZD8529
Intervention descriptions: intervention 1: comparison of different dosages of drug

Protocol document: