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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 : May 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kent Hutchison, Ph.D., The Mind Research Network

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 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
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

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



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



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

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

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 )
R01DA025074 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2010    Key Record Dates
Results First Posted: November 4, 2016
Last Update Posted: May 9, 2018
Last Verified: April 2018
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