Effectiveness of Varenicline: Testing Individual Differences

This study is currently recruiting participants.
Verified October 2013 by The Mind Research Network
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: October 30, 2013
Last verified: October 2013
  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: 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, BBA 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
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: October 30, 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 April 17, 2014