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Effectiveness of Varenicline: Testing Individual Differences

This study is currently recruiting participants.
Verified April 2013 by The Mind Research Network
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: April 29, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Smoking
U.S. FDA Resources

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: May 2014
Estimated Primary Completion Date: May 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228175

Contacts
Contact: Julie Morales, BA 505-414-9530 jmorales@mrn.org
Contact: Jessica Mickey 505-272-6059 jmickey@mrn.org

Locations
United States, New Mexico
The Mind Research Network Recruiting
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

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: April 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Riboflavin
Smoking
Behavior, Addictive
Habits
Compulsive Behavior
Impulsive Behavior
Varenicline
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013