A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers (rTMS)
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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:
- active condition: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues
- location control condition: low frequency rTMS was administered over motor cortex (MC) during the presentation of smoking and control cues
- frequency control condition: high frequency rTMS was administered over the SFG during the presentation of smoking and control cues
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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North Carolina
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Durham, North Carolina, Spojené státy, 27705
- Duke Center for Nicotine & Smoking Cessation Research
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 18 to 50 years of age;
- dependent smoker of > 10 cigarettes per day of cigarettes yielding >0.5mg nicotine (by Federal Trade Commission rated yields);
- have smoked cigarettes for at least three cumulative years;
- an afternoon carbon monoxide reading of at least 10ppm;
- be in general good health based on physical examination, EKG, serum chemistries, CBC, and urinalysis and
- show evidence of greater craving following exposure to in vivo smoking versus control cues
Exclusion Criteria:
- Individuals with a clinically defined neurological disorder or insult including, but not limited to, any condition likely to be associated with increased intracranial pressure;
- space occupying brain lesion;
- any history of seizure EXCEPT those therapeutically induced by ECT (Electro Convulsive Therapy);
- history of cerebrovascular accident;
- transient ischemic attack within two years;
- cerebral aneurysm;
- dementia;
- Parkinson's disease;
- Huntington's chorea;
- multiple sclerosis;
- current lung disease or lung disorder;
- hypertension (systolic >140 mmHg, diastolic > 90 mmHg);
- hypotension (< 90 mmHg, diastolic < 60 mmHg);
- coronary artery disease;
- cardiac rhythm disorder;
- impaired hepatic or renal function (based on documented diagnosis or abnormal chemistries) except gallstones or kidney stones;
- other major medical or psychiatric condition;
- use of any concurrent hypertensive, psychiatric, or psychoactive medication;
- any concurrent medication that lowers seizure threshold;
- smokeless tobacco, pipe, or cigar use in the past 30 days;
- nicotine replacement therapy, or other smoking cessation therapy within the past 30 days;
- increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for > 5 minutes;
- ECT treatment within 3 months prior to screening visit;
- failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher);
- a true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire;
- history of treatment with rTMS therapy for any disorder;
- use of any investigational drug within 30 days of the screening visit;
- history of treatment with Vagus Nerve Stimulation;
- use of any medication(s) with active CNS properties within 1 week of the screening visit;
- cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease; intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- known or suspected pregnancy;
- positive urine drug screen or reported drug abuse in the past 30 days;
- clinically significant laboratory abnormality, in the opinion of the investigator or study physician;
- women who are breast-feeding; women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse;
- current chronic pain or other pain condition that interferes with daily activities or requires use of prescription medication;
- claustrophobia or abnormal fear of cramped or confined space;
- Individuals where a motor threshold response is not elicited with stimulation at or below 80% of maximum output;
- active ulcer within the past 30 days;
- frequent migraines (great than four in the past 30 days);
- Females who score greater than or equal to 13 and males who score greater than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification Test)will be excluded from the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Aktivní komparátor: rTMS 90% MT - Low frequency rTMS
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
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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.
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Aktivní komparátor: Location Control
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
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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.
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Aktivní komparátor: Frequency Control
rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
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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.
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Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.
Časové okno: Following exposure to in vivo cues
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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.
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Following exposure to in vivo cues
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Craving for Cigarettes After Controlled Smoke Presentations.
Časové okno: After smoking a cigarette through the controlled puff volume apparatus during rTMS
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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.
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After smoking a cigarette through the controlled puff volume apparatus during rTMS
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Andrew D Krystal, M.D., M.S., Duke University
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- Pro00002339
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