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Effectiveness of Varenicline: Testing Individual Differences (Varenicline)

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kent Hutchison, Ph.D., The Mind Research Network
ClinicalTrials.gov Identifier:
NCT01228175
First received: September 8, 2010
Last updated: September 16, 2016
Last verified: September 2016
  Purpose
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01228175

Locations
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)
Investigators
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
ClinicalTrials.gov Identifier: NCT01228175     History of Changes
Other Study ID Numbers: R01DA025074 
Study First Received: September 8, 2010
Results First Received: September 16, 2016
Last Updated: September 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Riboflavin
Varenicline
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016