Nicotine Dependence
Conditions
Keywords
nicotine, craving, smoking, TMS, prefrontal cortex
Brief summary
The proposed study will measure the change of cortical excitability during nicotine craving and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine craving and cue-reactivity among adult regular smokers.
Detailed description
This pilot protocol proposes to test and further develop TMS for the purpose of studying brain function in nicotine users. Specific Primary Aims include: Aim # 1. To test change of cortical excitability during nicotine craving in cigarette smokers and explore the potential use of TMS in cigarette smokers. Aim # 2. Given the role of the prefrontal cortex (and connected regions) in craving, we will examine whether modulating prefrontal activity through rTMS will impact measures of craving and the reinforcing effects of nicotine. Design: The study was a randomized, blind, sham-controlled crossover study in which participants will involve two study visits. Participants will have an initial assessment about tobacco use habits and craving patterns. Participant will look at images related to and not related to cigarette smoking. Participants will receive two different types of brain stimulation with repetitive TMS (10 Hz): sham rTMS and active rTMS over prefrontal cortex. Craving assessments will be performed before and after each stimulus experiment. Participants will be measured cortical excitability with TMS before and after each stimulus experiment.
Interventions
DEVICETranscranial Magnetic Stimulation (Neuronetics)
Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.
DEVICESham Transcranial Magnetic Stimulation
The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Right handed males and females, between the ages of 18 and 50 * Daily smokers who smoke at least 10 cigarettes per day for at least past 1 year * Mentally capable of reading, writing, giving consent, following instructions
Exclusion criteria
* history of seizures * taking medications that lower seizure threshold * implanted metal devices (e.g., pacemakers, metal plates, wires) * pregnant * history of brain surgery or history of loss of consciousness \>15 minutes * any unstable major axis I psychiatric disorder in the past month (e.g. psychotic disorders) * Current substance use disorders other than nicotine and caffeine use, in the past 30 days * Any medication (e.g., propranolol) or unstable medical condition that may interfere with psychophysiological (e.g., heart rate) monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Change From Baseline in Cue Nicotine Craving Rating Score | Before rMTS (baseline) and after rTMS experiment (on average 15 minutes) | Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Change From Baseline in Resting Motor Threshold | 20 minutes before (baseline) and 20 minutes after rTMS experiment | Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcranial Magnetic Stimulation, Then Sham Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain. | 10 |
| Sham Transcranial Magnetic Stimulation, Then TMS Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject have cancelled visit. | 1 | 0 |
Baseline characteristics
| Characteristic | Transcranial Magnetic Stimulation, Then Sham | Sham Transcranial Magnetic Stimulation, Then TMS | 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 | 9 Participants | 19 Participants |
| Age, Continuous | 42 year STANDARD_DEVIATION 11.5 | 42 year STANDARD_DEVIATION 11.5 | 42 year STANDARD_DEVIATION 11.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 15 Participants |
| Region of Enrollment United States | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 1 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
the Change From Baseline in Cue Nicotine Craving Rating Score
Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.
Time frame: Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Magnetic Stimulation | the Change From Baseline in Cue Nicotine Craving Rating Score | 64 score on a scale | Standard Deviation 5.9 |
| Sham Transcranial Magnetic Stimulation | the Change From Baseline in Cue Nicotine Craving Rating Score | 46 score on a scale | Standard Deviation 6.4 |
Secondary
the Change From Baseline in Resting Motor Threshold
Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response
Time frame: 20 minutes before (baseline) and 20 minutes after rTMS experiment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcranial Magnetic Stimulation | the Change From Baseline in Resting Motor Threshold | 42 units on a scale | Standard Error 8.1 |
| Sham Transcranial Magnetic Stimulation | the Change From Baseline in Resting Motor Threshold | 44 units on a scale | Standard Error 9.8 |