Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers

NCT00934024 | Completed Results

• 1 other identifier: HR#18521
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the impact of varenicline treatment on cue induced craving to smoking using brain imaging. The investigators hypothesize that participants will report reduced urges to smoke and will have less activation in parts of the brain associated with craving.

Conditions

Nicotine Dependence

Keywords

nicotine dependence; tobacco; smoking

Outcome Measures

Primary Outcomes (1)

• Change in Post-Resist Craving

  Change in Post-resist task craving between Scan 1, pre-medication, and Scan 2, post- medication, as measured on a 0-10 Likert scale. The Within Sessions Rating scale (Range 0-10) measures craving with 0 indicating Not at All and 10 indicating Extremely. Change scores were calculate by subtracting the craving score immediately following the pre-medication scan from the craving score immediately following the post-medication scan.

  5 weeks

Study Arms (2)

Abstinent

OTHER

All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. This arm was abstinent after 5 weeks of varenicline treatment..

Drug: varenicline

Non-abstinent

OTHER

All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. This arm was participants who continued to smoke after 5 weeks of varenicline treatment.

Drug: varenicline

Interventions

varenicline DRUG

Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months.

Also known as: Chantix

Abstinent; Non-abstinent

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21 - 60 treatment-seeking right handed smokers.
• Meet criteria for primary nicotine dependence confirmed by FTND and smoked at least 70% of days in the last 30 days prior to assessment.
• General good health confirmed by history \& physical.
• Able to read and understand questionnaires and informed consent.
• Motivated to quit, willing to set a target quit date (TQD) and abstain from smoking after TDQ.
• Participants must have a negative urine drug screen (UDS) and pregnancy test prior to imaging sessions and beginning varenicline treatment.
• Female participants will use a reliable method of birth control throughout the study.
• Demonstrate subjective response to cues in a laboratory cue reactivity session.

You may not qualify if:

• Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
• Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
• Use of other tobacco products.
• Current use of nicotine replacement therapy, bupropion, or other smoking cessation treatment.
• Previous failed attempt on varenicline.
• Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
• Current suicidal ideation with plan or homicidal ideation.
• Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
• Clinically significant medical problems that would impair participation or limit ability to participate in scan.
• Sexually active females of child-bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
• Has current charges pending for a violent crime (not including DUI related offenses).
• Persons with ferrous metal implants or pacemaker since fMRI will be used.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Karen Hartwell
• Organization: MUSC

hartwelk@musc.edu

843-792-8174

Study Officials

• Karen Hartwell, M.D.

  Medical Universtiy of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: April 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 10, 2018
• Results First Posted: December 10, 2018

Record last verified: 2018-12

Locations

US (1)