Varenicline on Reward Responses and Cognition in Adolescent Smokers

NCT01624428 | Completed Phase 1 DMC

• 1 other identifier: 1108008929
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorders

Keywords

Tobacco; Adolescent; Nicotine; Magnetic Resonance Imaging; Varenicline

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

varenicline

ACTIVE COMPARATOR

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Varenicline DRUG

1 mg bid varenicline titrated over a 2 week period

Also known as: Chantix

varenicline

Placebo DRUG

1 mg bid placebo titrated over a 2 week period

Placebo

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Substance Abuse Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Study Officials

• Suchitra Krishnan-Sarin, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 20, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (1)