Varenicline on Reward Responses and Cognition in Adolescent Smokers

Phase 1

Completed

• Conditions: Tobacco Use Disorders
• Interventions: Drug: Placebo; Drug: Varenicline

• Registration Number: NCT01624428
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-30
• Last Update Posted: 2014-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
varenicline	Varenicline	-

Primary Outcome Measures

Name	Time	Method
neural responses to the MIDT	During MRI following14 days of varenicline treatment	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	During MRI following14 days of varenicline treatment	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	During MRI following14 days of varenicline treatment	The Stroop will be administered during the fMRI at the end of 14 days of varenicline treatment

Trial Locations

Locations (1)

Substance Abuse Center; 🇺🇸 New Haven, Connecticut, United States