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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00901459
A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers (rTMS)
17 dicembre 2012 aggiornato da: Duke University
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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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
Tipo di studio
Interventistico
Iscrizione (Effettivo)
21
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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North Carolina
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Durham, North Carolina, Stati Uniti, 27705
- Duke Center for Nicotine & Smoking Cessation Research
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 50 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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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Comparatore attivo: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Craving for Cigarettes After Controlled Smoke Presentations.
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Andrew D Krystal, M.D., M.S., Duke University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2009
Completamento primario (Effettivo)
1 agosto 2010
Completamento dello studio (Effettivo)
1 agosto 2010
Date di iscrizione allo studio
Primo inviato
11 maggio 2009
Primo inviato che soddisfa i criteri di controllo qualità
12 maggio 2009
Primo Inserito (Stima)
13 maggio 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
25 gennaio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 dicembre 2012
Ultimo verificato
1 dicembre 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Pro00002339
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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