Clinical trial NCT01624428: Varenicline on Reward Responses and Cognition in Adolescent Smokers
Official title: Examining the Effects of Varenicline on Reward Responses,Cognition, and Tobacco Cues in Adolescent Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Disorders
Keywords: Tobacco
Adolescent
Nicotine
Magnetic Resonance Imaging
Varenicline
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 16
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: neural responses to the MIDT
timeFrame: During MRI following14 days of varenicline treatment
measure: neural responses to the ROC
timeFrame: During MRI following14 days of varenicline treatment
measure: neural responses to the Stroop
timeFrame: During MRI following14 days of varenicline treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Suchitra Krishnan-Sarin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: