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Effectiveness of Varenicline: Testing Individual Differences (Varenicline)

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kent Hutchison, Ph.D., The Mind Research Network Identifier:
First received: September 8, 2010
Last updated: September 16, 2016
Last verified: September 2016
The study will test genetic factors that may predict the effectiveness of varenicline.

Condition Intervention Phase
Smoking Addiction
Drug: Placebo
Drug: Varenicline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Varenicline: Testing Individual Differences

Resource links provided by NLM:

Further study details as provided by The Mind Research Network:

Primary Outcome Measures:
  • Cigarettes Per Smoking Day [ Time Frame: up to 36 weeks ]

Enrollment: 341
Study Start Date: March 2010
Study Completion Date: March 2016
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Varenicline
Drug: Varenicline
Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily
Other Name: Chantix
Placebo Comparator: Microcrystal Cellulose
Microcrystal cellulose placebo
Drug: Placebo
25mg look alike riboflavin tablets to match active study medication.
Other Name: riboflavin


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18 yrs to 55 yrs
  • smoker

Exclusion Criteria:

  • Medical Contraindications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01228175

United States, New Mexico
The Mind Research Network
Albuquerque, New Mexico, United States, 87106
Sponsors and Collaborators
The Mind Research Network
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kent Hutchison, Ph.D Director, Neurogenetics Core, The Mind Research Network
  More Information

Responsible Party: Kent Hutchison, Ph.D., Chief Science Officer, The Mind Research Network Identifier: NCT01228175     History of Changes
Other Study ID Numbers: R01DA025074 ( US NIH Grant/Contract Award Number )
Study First Received: September 8, 2010
Results First Received: September 16, 2016
Last Updated: September 16, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances
Photosensitizing Agents
Dermatologic Agents processed this record on May 23, 2017