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Effectiveness of Varenicline: Testing Individual Differences

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kent Hutchison, Ph.D., The Mind Research Network
ClinicalTrials.gov Identifier:
NCT01228175
First received: September 8, 2010
Last updated: July 2, 2014
Last verified: July 2014
  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 ]

Estimated Enrollment: 216
Study Start Date: March 2010
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (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 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
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
Investigators
Principal Investigator: Kent Hutchison, Ph.D Director, Neurogenetics Core, The Mind Research Network
  More Information

No publications provided

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, R01DA025074
Study First Received: September 8, 2010
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014