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

Primary Purpose

Tobacco Use Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorders focused on measuring Tobacco, Adolescent, Nicotine, Magnetic Resonance Imaging, Varenicline

Eligibility Criteria

16 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Substance Abuse Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

varenicline

Placebo

Arm Description

Outcomes

Primary Outcome Measures

neural responses to the MIDT
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
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
The Stroop will be administered during the fMRI at the end of 14 days of varenicline treatment

Secondary Outcome Measures

Full Information

First Posted
June 18, 2012
Last Updated
January 30, 2014
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01624428
Brief Title
Varenicline on Reward Responses and Cognition in Adolescent Smokers
Acronym
GRAND
Official Title
Examining the Effects of Varenicline on Reward Responses,Cognition, and Tobacco Cues in Adolescent Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorders
Keywords
Tobacco, Adolescent, Nicotine, Magnetic Resonance Imaging, Varenicline

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
varenicline
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
1 mg bid varenicline titrated over a 2 week period
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 mg bid placebo titrated over a 2 week period
Primary Outcome Measure Information:
Title
neural responses to the MIDT
Description
The Monetary Incentive Delay Task (MIDT) will be administered during the fMRI at the end of 14 days of varenicline treatment
Time Frame
During MRI following14 days of varenicline treatment
Title
neural responses to the ROC
Description
The Regulation of Craving (ROC)will be administered during the fMRI at the end of 14 days of varenicline treatment
Time Frame
During MRI following14 days of varenicline treatment
Title
neural responses to the Stroop
Description
The Stroop will be administered during the fMRI at the end of 14 days of varenicline treatment
Time Frame
During MRI following14 days of varenicline treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suchitra Krishnan-Sarin, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Substance Abuse Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Varenicline on Reward Responses and Cognition in Adolescent Smokers

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