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Effectiveness of Varenicline: Testing Individual Differences (Varenicline)

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ClinicalTrials.gov Identifier: NCT01228175
Recruitment Status : Completed
First Posted : October 26, 2010
Results First Posted : November 4, 2016
Last Update Posted : November 4, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study will test genetic factors that may predict the effectiveness of varenicline.

Condition or disease Intervention/treatment Phase
Smoking Addiction Drug: Placebo Drug: Varenicline Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Varenicline: Testing Individual Differences
Study Start Date : March 2010
Primary Completion Date : February 2015
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 18 yrs to 55 yrs
  • smoker

Exclusion Criteria:

  • Medical Contraindications
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2010    Key Record Dates
Results First Posted: November 4, 2016
Last Update Posted: November 4, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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