Nicotine Dependence
Conditions
Keywords
nicotine dependence, tobacco, smoking
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.
Detailed 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.
Interventions
DRUGvarenicline
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.
Sponsors
Medical University of South Carolina
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-Resist Craving | 5 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Right-handed nicotine dependent cigarette smokers between 21 and 60 years of age were recruited via community and internet advertisements. Recruitment took place between 2009 and 2011.
Pre-assignment details
All participants received open-label varenicline. Participants data was anaylzed in two groups- abstinent and non-abstinent participants.
Participants by arm
| Arm | Count |
|---|---|
| Abstinent 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. | 10 |
| Non-Abstinent 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. | 11 |
| Total | 21 |
Baseline characteristics
| Characteristic | Abstinent | Non-Abstinent | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Continuous | 24.8 Years STANDARD_DEVIATION 13.07 | 35.55 Years STANDARD_DEVIATION 11.72 | 30.18 Years STANDARD_DEVIATION 12.4 |
| cigarettes per day | 20.45 Cigarettes per day STANDARD_DEVIATION 5.83 | 17.27 Cigarettes per day STANDARD_DEVIATION 4.29 | 18.86 Cigarettes per day STANDARD_DEVIATION 5.06 |
| Region of Enrollment United States | 10 participants | 11 participants | 21 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 16 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Abstinent | Change in Post-Resist Craving | 6 units on a scale | Standard Deviation 1.41 |
| Non-abstinent | Change in Post-Resist Craving | 3.6 units on a scale | Standard Deviation 1.14 |