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The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) to block craving for cigarettes in smokers. rTMS is an investigational procedure, where a device called a "stimulator" provides electricity to a device that creates a magnetic field. This device is placed against the scalp in the front of the head so that the magnetic field is focused on an area of the brain that is thought to be involved in craving for cigarettes. rTMS is an investigational procedure so therefore being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). Changes in magnetic fields during rTMS administration change electrical currents which may affect brain activity and function.
The goal of this study is to evaluate the effects of rTMS on cue-induced craving in dependent smokers. We hypothesize that low frequency rTMS over the SFG will block cue-induced craving. In order to test this hypothesis, subjects will undergo three conditions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTMS 90% MT - Low frequency rTMS | Active Comparator | Intervention type: device. Intervention description: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues using 90% MT (Motor Threshold) 1 Hz rTMS Dose on Superior Frontal Gyrus |
|
| Location Control | Active Comparator | rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex |
|
| Frequency Control | Active Comparator | rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS Condition | Device | Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design. | Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING ("urges to smoke," "miss a cigarette," and "crave cigarettes"), MOOD ("calm," "tense," and "irritable"), AROUSAL ("wide awake," "able to concentrate"), and HUNGER ("feel hungry"). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving. | Following exposure to in vivo cues |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Craving for Cigarettes After Controlled Smoke Presentations. | Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire ("Did it immediately reduce your craving for cigarettes?") after smoking presentations through the controlled puff volume apparatus. | After smoking a cigarette through the controlled puff volume apparatus during rTMS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jed E Rose, Ph.D. | Duke University | Principal Investigator |
| Andrew D Krystal, M.D., M.S. | Duke University | Principal Investigator |
| Francis J McClernon, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center for Nicotine & Smoking Cessation Research | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21762878 | Derived | Rose JE, McClernon FJ, Froeliger B, Behm FM, Preud'homme X, Krystal AD. Repetitive transcranial magnetic stimulation of the superior frontal gyrus modulates craving for cigarettes. Biol Psychiatry. 2011 Oct 15;70(8):794-799. doi: 10.1016/j.biopsych.2011.05.031. Epub 2011 Jul 18. |
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Of the 148 participants that were consented for this study only 21 subjects met study criteria the others were excluded from participation for the following reasons:
70-Did Not Meet Inclusion Criteria 6-Lab Results 6-Lost to Contact 26-Medical 14-Met exclusion criteria 3-Refused to participate 2-Unable To Meet Study Requirements
The first participant was consented on 5/12/2009 and the final participant on 6/22/2010 at the Duke Center for Nicotine and Smoking Cessation Research. During the recruitment phase of the study 148 potential subjects were consented and 7 read the consent form and chose not to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Active: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus Location Control: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex Frequency Control: rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Active: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus Location Control: rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex Frequency Control: rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design. | Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING ("urges to smoke," "miss a cigarette," and "crave cigarettes"), MOOD ("calm," "tense," and "irritable"), AROUSAL ("wide awake," "able to concentrate"), and HUNGER ("feel hungry"). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving. | A repeated measures design exposed participants to three different rTMS conditions over 3 separate visits, with order counterbalanced using latin square design. | Posted | Mean | Standard Error | units on a scale | Following exposure to in vivo cues |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jed E. Rose, Ph.D. | Duke Center for Nicotine and Smoking Cessation Research | 919-668-5055 | jed.rose@mc.duke.edu |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| rTMS Location Control Condition | Device | Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the motor cortex (MC) during the presentation of smoking and control cues. |
|
| rTMS Frequency Control Condition | Device | High frequency rTMS (90% Motor Threshold at 10 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues. |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Active | rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus |
| OG001 | Location Control | rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex |
| OG002 | Frequency Control | rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTMS Location: Superior Frontal Gyrus |
|
|
|
| Secondary | Change in Craving for Cigarettes After Controlled Smoke Presentations. | Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire ("Did it immediately reduce your craving for cigarettes?") after smoking presentations through the controlled puff volume apparatus. | Posted | Mean | Standard Deviation | units on a scale | After smoking a cigarette through the controlled puff volume apparatus during rTMS |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Location Control | rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex | 0 | 15 | 0 | 15 |
| EG002 | Frequency Control | rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus | 0 | 15 | 0 | 15 |
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