Varenicline on Reward Responses and Cognition in Adolescent Smokers

Tobacco Use Disorders Clinical Trial

— GRAND  

Official title:

Examining the Effects of Varenicline on Reward Responses,Cognition, and Tobacco Cues in Adolescent Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01624428
• Other study ID #: 1108008929
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2012
• Last updated: January 30, 2014
• Start date: June 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 19 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tobacco Use Disorder
• Tobacco Use Disorders

Intervention

Drug:
• Varenicline
1 mg bid varenicline titrated over a 2 week period
• Placebo
1 mg bid placebo titrated over a 2 week period

Locations

Country	Name	City	State
United States	Substance Abuse Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During MRI following14 days of varenicline treatment	No
Primary	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	During MRI following14 days of varenicline treatment	No
Primary	neural responses to the Stroop	The Stroop will be administered during the fMRI at the end of 14 days of varenicline treatment	During MRI following14 days of varenicline treatment	No