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

Nicotine Dependence Clinical Trial

— GRAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934024
• Other study ID #: HR#18521
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: January 2012

Study information

• Verified date: December 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Treatment with varenicline reduces overall subjective cigarette craving and smoking reward in nicotine-dependent smokers. This preliminary study will explore the impact of varenicline treatment on smoking cue-induced craving and associated regional brain activation using BOLD fMRI. Twenty healthy smokers (10 males, 10 females) will undergo two BOLD fMRI scans with the presentation of smoking-related and neutral cues at baseline and after five weeks of treatment with open-label varenicline. The investigators hypothesize that participants will report reduced urges to smoke on the Questionnaire of Smoking Urges-Brief and have less activation of the brain areas associated with craving during the fMRI after 5 weeks of varenicline and smoking cessation counseling compared to the baseline scan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 21 - 60 treatment-seeking right handed smokers.

2. Meet criteria for primary nicotine dependence confirmed by FTND and smoked at least 70% of days in the last 30 days prior to assessment.

3. General good health confirmed by history & physical.

4. Able to read and understand questionnaires and informed consent.

5. Motivated to quit, willing to set a target quit date (TQD) and abstain from smoking after TDQ.

6. Participants must have a negative urine drug screen (UDS) and pregnancy test prior to imaging sessions and beginning varenicline treatment.

7. Female participants will use a reliable method of birth control throughout the study.

8. Demonstrate subjective response to cues in a laboratory cue reactivity session.

Exclusion Criteria:

1. Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.

2. Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.

3. Use of other tobacco products.

4. Current use of nicotine replacement therapy, bupropion, or other smoking cessation treatment.

5. Previous failed attempt on varenicline.

6. 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.

7. Current suicidal ideation with plan or homicidal ideation.

8. Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.

9. Clinically significant medical problems that would impair participation or limit ability to participate in scan.

10. Sexually active females of child-bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.

11. Has current charges pending for a violent crime (not including DUI related offenses).

12. Persons with ferrous metal implants or pacemaker since fMRI will be used.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• varenicline
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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