Varenicline on Reward Responses and Cognition in Adolescent Smokers (GRAND)
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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 |
- 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
| Estimated Enrollment: | 16 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 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 |
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| Contact: Amanda Liss, B.A. | 203-974-7814 | amanda.liss@yale.edu |
| Contact: Dana A Cavallo, Ph.D. | 203-974-7607 | dana.cavallo@yale.edu |
| United States, Connecticut | |
| Substance Abuse Center | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| 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: | May 13, 2013 |
| 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 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 June 17, 2013