Varenicline on Reward Responses and Cognition in Adolescent Smokers

NCT ID: NCT01624428

Last Updated: 2014-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Tobacco Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

varenicline

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

1 mg bid varenicline titrated over a 2 week period

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 mg bid placebo titrated over a 2 week period

Interventions

Varenicline

1 mg bid varenicline titrated over a 2 week period

Intervention Type: DRUG

Placebo

1 mg bid placebo titrated over a 2 week period

Intervention Type: DRUG

Other Intervention Names

Chantix

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suchitra Krishnan-Sarin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Substance Abuse Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1108008929

Identifier Type: -

Identifier Source: org_study_id