Effectiveness of Varenicline: Testing Individual Differences

Smoking Addiction Clinical Trial

— Varenicline  

Official title:

Effectiveness of Varenicline: Testing Individual Differences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01228175
• Other study ID #: R01DA025074
• Secondary ID: R01DA025074
• Status: Completed
• Phase: Phase 4
• Start date: March 2010
• Est. completion date: March 2016

Study information

• Verified date: April 2018
• Source: The Mind Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: March 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 18 yrs to 55 yrs

• smoker

Exclusion Criteria:

• Medical Contraindications

Related Conditions & MeSH terms

• Smoking Addiction

Intervention

Drug:
• Placebo
25mg look alike riboflavin tablets to match active study medication.
• Varenicline
Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily

Locations

Country	Name	City	State
United States	The Mind Research Network	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
The Mind Research Network	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarettes Per Smoking Day	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.	up to 36 weeks