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A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers (rTMS)

17 december 2012 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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:

  1. active condition: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues
  2. location control condition: low frequency rTMS was administered over motor cortex (MC) during the presentation of smoking and control cues
  3. frequency control condition: high frequency rTMS was administered over the SFG during the presentation of smoking and control cues

Studietype

Ingrijpend

Inschrijving (Werkelijk)

21

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • North Carolina
      • Durham, North Carolina, Verenigde Staten, 27705
        • Duke Center for Nicotine & Smoking Cessation Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 50 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. 18 to 50 years of age;
  2. dependent smoker of > 10 cigarettes per day of cigarettes yielding >0.5mg nicotine (by Federal Trade Commission rated yields);
  3. have smoked cigarettes for at least three cumulative years;
  4. an afternoon carbon monoxide reading of at least 10ppm;
  5. be in general good health based on physical examination, EKG, serum chemistries, CBC, and urinalysis and
  6. show evidence of greater craving following exposure to in vivo smoking versus control cues

Exclusion Criteria:

  1. Individuals with a clinically defined neurological disorder or insult including, but not limited to, any condition likely to be associated with increased intracranial pressure;
  2. space occupying brain lesion;
  3. any history of seizure EXCEPT those therapeutically induced by ECT (Electro Convulsive Therapy);
  4. history of cerebrovascular accident;
  5. transient ischemic attack within two years;
  6. cerebral aneurysm;
  7. dementia;
  8. Parkinson's disease;
  9. Huntington's chorea;
  10. multiple sclerosis;
  11. current lung disease or lung disorder;
  12. hypertension (systolic >140 mmHg, diastolic > 90 mmHg);
  13. hypotension (< 90 mmHg, diastolic < 60 mmHg);
  14. coronary artery disease;
  15. cardiac rhythm disorder;
  16. impaired hepatic or renal function (based on documented diagnosis or abnormal chemistries) except gallstones or kidney stones;
  17. other major medical or psychiatric condition;
  18. use of any concurrent hypertensive, psychiatric, or psychoactive medication;
  19. any concurrent medication that lowers seizure threshold;
  20. smokeless tobacco, pipe, or cigar use in the past 30 days;
  21. nicotine replacement therapy, or other smoking cessation therapy within the past 30 days;
  22. 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;
  23. ECT treatment within 3 months prior to screening visit;
  24. failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher);
  25. a true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire;
  26. history of treatment with rTMS therapy for any disorder;
  27. use of any investigational drug within 30 days of the screening visit;
  28. history of treatment with Vagus Nerve Stimulation;
  29. use of any medication(s) with active CNS properties within 1 week of the screening visit;
  30. 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;
  31. known or suspected pregnancy;
  32. positive urine drug screen or reported drug abuse in the past 30 days;
  33. clinically significant laboratory abnormality, in the opinion of the investigator or study physician;
  34. women who are breast-feeding; women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse;
  35. current chronic pain or other pain condition that interferes with daily activities or requires use of prescription medication;
  36. claustrophobia or abnormal fear of cramped or confined space;
  37. Individuals where a motor threshold response is not elicited with stimulation at or below 80% of maximum output;
  38. active ulcer within the past 30 days;
  39. frequent migraines (great than four in the past 30 days);
  40. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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
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.
Actieve vergelijker: Location Control
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
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.
Actieve vergelijker: Frequency Control
rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.
Tijdsspanne: Following exposure to in vivo cues
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Craving for Cigarettes After Controlled Smoke Presentations.
Tijdsspanne: After smoking a cigarette through the controlled puff volume apparatus during rTMS
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: Andrew D Krystal, M.D., M.S., Duke University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2009

Primaire voltooiing (Werkelijk)

1 augustus 2010

Studie voltooiing (Werkelijk)

1 augustus 2010

Studieregistratiedata

Eerst ingediend

11 mei 2009

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2009

Eerst geplaatst (Schatting)

13 mei 2009

Updates van studierecords

Laatste update geplaatst (Schatting)

25 januari 2013

Laatste update ingediend die voldeed aan QC-criteria

17 december 2012

Laatst geverifieerd

1 december 2012

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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