Varenicline on Reward Responses and Cognition in Adolescent Smokers (GRAND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01624428
First received: June 18, 2012
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the influence of varenicline on reward processing, cognitive control, and regulation of craving in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when compared with those receiving placebo, will have differential brain responses to anticipation of rewards, during exposure to the Stroop task, and in response to tobacco cues.


Condition Intervention Phase
Tobacco Use Disorders
Drug: Varenicline
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Examining the Effects of Varenicline on Reward Responses,Cognition, and Tobacco Cues in Adolescent Smokers

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • neural responses to the MIDT [ Time Frame: During MRI following14 days of varenicline treatment ] [ Designated as safety issue: No ]
    The Monetary Incentive Delay Task (MIDT) will be administered during the fMRI at the end of 14 days of varenicline treatment

  • neural responses to the ROC [ Time Frame: During MRI following14 days of varenicline treatment ] [ Designated as safety issue: No ]
    The Regulation of Craving (ROC)will be administered during the fMRI at the end of 14 days of varenicline treatment

  • neural responses to the Stroop [ Time Frame: During MRI following14 days of varenicline treatment ] [ Designated as safety issue: No ]
    The Stroop will be administered during the fMRI at the end of 14 days of varenicline treatment


Enrollment: 16
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline Drug: Varenicline
1 mg bid varenicline titrated over a 2 week period
Other Name: Chantix
Placebo Comparator: Placebo Drug: Placebo
1 mg bid placebo titrated over a 2 week period

Detailed Description:

This is a pilot project using functional magnetic resonance imaging (fMRI) to examine the influence of varenicline on reward processing, cognitive control, and regulation of craving in adolescent smokers. We hypothesize that adolescent smokers receiving varenicline, when compared with those receiving placebo, will have increased activation of the ventral striatum (VS) in response to anticipation of rewards in the Monetary Incentive Delay Task (MIDT), decreased activation of the dorsolateral prefrontal cortex (dlPFC) during exposure to incongruent stimuli in the Stroop task, and reduced activation of the ventral striatum in response to tobacco cues, and increased activation of the dlPFC during regulation of responses to tobacco cues during the Regulation of Craving (ROC) task. The results of this pilot project will have important implications regarding the use of varenicline for treating tobacco dependence and understanding varenicline's neurobiological effects in adolescent smokers.

  Eligibility

Ages Eligible for Study:   16 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 16-19 years of age
  • Able to read and write English
  • Smoking 5 or more cigarettes on a daily basis, for at least one year
  • Not seeking smoking cessation treatment
  • Weighing > 55 kg (121 lbs)

Exclusion Criteria:

  • Current criteria for abuse or dependence on another psychoactive substance.
  • Current diagnosis of any clinical significant psychiatric disease like major depressive disorder, panic or anxiety disorder, psychosis, schizophrenia, bipolar disorder.
  • Those with a prior suicide attempt or with active suicidal ideation at baseline
  • Any regular use of any psychoactive drugs including anxiolytics and antidepressants
  • Pregnant or lactating girls: females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least 14 days prior to study medication administration until 30 days after the last dose of study medication. Acceptable methods of contraception are: abstinence; any form of hormonal contraception such as Depo-Provera, daily oral contraceptive, transdermal patch, or Nuva-ring; intra-uterine device, sterilization; or double barrier contraception which is a combination of any two of the following methods: condoms, spermicide, diaphragm.
  • Evidence or history of clinically significant neurological, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or allergic disease.
  • History of prior use of or sensitivity to varenicline.
  • Color-blindness
  • History of significant head trauma
  • Metal in body
  • Other medical conditions contra-indicated for MRI
  • Past history of marked irritability or agitation when attempting to quit smoking, determined by the Minnesota Nicotine Withdrawal Questionnaire.
  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: NCT01624428

Locations
United States, Connecticut
Substance Abuse Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Suchitra Krishnan-Sarin, Ph.D. Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01624428     History of Changes
Other Study ID Numbers: 1108008929
Study First Received: June 18, 2012
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Yale University:
Tobacco
Adolescent
Nicotine
Magnetic Resonance Imaging
Varenicline

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014