Overview

This trial is active, not recruiting.

Condition smoking addiction
Treatments placebo, varenicline
Phase phase 4
Sponsor The Mind Research Network
Collaborator National Institute on Drug Abuse (NIDA)
Start date March 2010
End date March 2016
Trial size 216 participants
Trial identifier NCT01228175, R01DA025074

Summary

The study will test genetic factors that may predict the effectiveness of varenicline.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
varenicline Chantix
Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily
(Placebo Comparator)
placebo riboflavin
25mg look alike riboflavin tablets to match active study medication.

Primary Outcomes

Measure
Cigarettes per smoking day
time frame: up to 36 weeks

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - 18 yrs to 55 yrs - smoker Exclusion Criteria: - Medical Contraindications

Additional Information

Official title Effectiveness of Varenicline: Testing Individual Differences
Principal investigator Kent Hutchison, Ph.D
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by The Mind Research Network.