Effectiveness of Varenicline: Testing Individual Differences

Phase 4

Completed

• Conditions: Smoking Addiction
• Interventions: Drug: Varenicline; Drug: Placebo

• Registration Number: NCT01228175
• Lead Sponsor: The Mind Research Network

Brief Summary

The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Primary Completion: 2015-02
• Study Completion: 2016-03
• Results First Submitted: 2016-09-16
• Results First Submitted QC: 2016-09-16
• Results First Posted: 2016-11-04
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• 18 yrs to 55 yrs
• smoker

Exclusion Criteria

• Medical Contraindications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline	Varenicline	Varenicline
Microcrystal Cellulose	Placebo	Microcrystal cellulose placebo

Primary Outcome Measures

Name	Time	Method
Cigarettes Per Smoking Day	up to 36 weeks	The number of cigarettes smoked were assessed only on a "smoking day", i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks.

Trial Locations

Locations (1)

The Mind Research Network; 🇺🇸 Albuquerque, New Mexico, United States