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tDCS Effects on Resisting Smoking: Dose Ranging Study (RDR)

27 februari 2019 bijgewerkt door: University of Pennsylvania
Behaviors such as tobacco use, unhealthy diet, and sedentary behavior have far-reaching health implications. These modifiable behaviors account for a substantial proportion of deaths from cancer, cardiovascular disease and diabetes, and take a significant economic toll. Yet, many unhealthy behaviors are very resistant to change, despite widespread knowledge of the risks. Although theories of behavior change have been advanced to explain the persistence of these behaviors, few consider the neurobehavioral underpinnings. These approaches also fail to address a fundamental aspect of behavior change - an individual's ability to exert sufficient self-control to overcome temptations for immediate gratification and/or to maintain attention to long-term goals. With advances in the neuroimaging field, the investigators are learning where and how self-control over decisions and behaviors is executed in the brain. This work points to the central role of neural activity in the dorsolateral prefrontal cortices (DLPFC) in self-control processes that contribute to healthy choices. Further, emerging evidence shows that activity in the prefrontal cortices and cognitive control circuits can be modulated using a noninvasive and safe intervention: direct current transcranial stimulation (tDCS). The investigators pilot study, IRB study #820231, demonstrated that a single session of 1mA tDCS increased the ability to resist smoking in a validated smoking lapse paradigm. The current study will use a between-subject design to investigate the dose/response relationship between tDCS (administered at 1mA, 2mA, or sham stimulation for three sessions) and ability to resist smoking.

Studie Overzicht

Toestand

Voltooid

Gedetailleerde beschrijving

This trial will use a between-subject single blind design in which participants will be randomized to one of three tDCS dosage groups (1mA, 2mA or sham) and will receive three 20 minute sessions of the same dosage over the course of 1 week before completing a 7 day quit attempt. Eligible participants will complete an Intake Visit (week -1) for final eligibility determination, and complete baseline measures (if eligible). Participants will then be randomly assigned to one of the three dosage groups (1mA, 2mA or sham) and will attend three identical tDCS resist-smoking sessions (study days 1, 3, & 5) during which they will receive 20 minutes of their assigned tDCS dosage and complete cognitive tasks and a resist smoking paradigm. During the resist smoking sessions, participants will receive a session of their assigned dosage of tDCS for 20 minutes while being exposed to in vivo smoking cues (their cigarette pack, cigarettes, an ashtray). Participants will not be informed of their dosage condition. During and after the tDCS session, participants will have the opportunity to smoke in the approved smoking lab. The investigators will measure time to first cigarette and subsequent ad libitum smoking during the resist smoking paradigm. Following Session 3 participants will receive a 20 minute coaching session from a trained smoking cessation counselor to help them prepare for a 7-day quit attempt. During the 7-day quit attempt participants will be asked to attend 4 monitoring visits (study days 6, 8, 10 & 12) to confirm smoking status.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

172

Fase

  • Niet toepasbaar

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

    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19104
        • University of Pennsylvania

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 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Healthy males and females who are between 18 and 60 years of age
  2. Report smoking at least 10 cigarettes per day for the past year and have a CO value of > 10ppm at intake
  3. Planning to live in the area for at least the next 2 months;
  4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
  5. Able to communicate fluently in English (speaking, writing, and reading);
  6. Smokers who answer yes on a question regarding motivation to quit smoking.

Exclusion Criteria:

Alcohol/Drugs:

  1. History or current diagnosis or treatment for alcohol or drug abuse (as reported during phone screen);
  2. Positive breath alcohol concentration test (BrAC >0.01) at any study visit. a. Participants testing positive for breath alcohol with a reading equal to or greater than .08 (the legal driving limit) or who are visibly impaired will be instructed not to drive themselves home after the appointment. If a participant needs to use a phone to call for a safe ride home, an office telephone will be made available to the participant.

Medication:

Current use or recent discontinuation (within the last 14 days at the time of Intake) of:

  1. Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix);
  2. Anti-psychotic medications;
  3. Nicotine replacement therapy (NRT);
  4. GABAergic medications;
  5. Glutamatergic medications;
  6. Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician.

    Daily use of:

  7. Opiate-containing medications for chronic pain;
  8. Benzodiazepines.

Medical/Neuropsychiatric:

  1. Women who are pregnant, planning a pregnancy, and/or breast feeding. All female subjects will complete a urine pregnancy test at the intake visit and preceding all brain stimulation sessions (4 urine pregnancy tests in total);
  2. History of epilepsy or a seizure disorder;
  3. History of stroke;
  4. Self-reported history of brain or spinal tumor;
  5. Self-reported history or current diagnosis of psychosis, including schizophrenia, mania, bipolar disorder, major depression (subjects with a history of major depression but in remission for past 6 months are eligible).

tDCS-related:

  1. Self-report of metallic objects in the face or head other than dental apparatus (e.g. braces, fillings, and implants);
  2. Self-report of pacemakers or implantable cardioverter-defibrillator (ICD).
  3. Self-report of any skull fracture or opening.

General Exclusion:

  1. Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator;
  2. Low or borderline intellectual functioning - determined by a score of less than 90 on the Shipley Institute of Living Scale (SILS) (administered at Intake Visit). The SILS correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated IQ Test;
  3. Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.

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: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Sham dose
Participants in this arm will receive the sham transcranial direct current stimulation (tDCS) procedure. During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS.

Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).

Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS.

Andere namen:
  • tDCS, neuroConn DC-Stimulator Plus
Experimenteel: 1mA dose
Participants in this arm will receive the 1mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).

Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).

Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS.

Andere namen:
  • tDCS, neuroConn DC-Stimulator Plus
Experimenteel: 2 mA dose
Participants in this arm will receive the 2 mA transcranial direct current stimulation (tDCS) procedure. A neuroConn DC-Stimulator Plus will apply a constant direct current (2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).

Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).

Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS.

Andere namen:
  • tDCS, neuroConn DC-Stimulator Plus

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Resisting Smoking - Time to First Cigarette in the Resist Smoking Paradigm
Tijdsspanne: During laboratory session on day 5, assessed for up to 2 hours
Participant smoking behavior will be assessed during the laboratory session using a validated smoking lapse paradigm. The primary outcome measure is time to first cigarette in minutes.
During laboratory session on day 5, assessed for up to 2 hours
Resisting Smoking - Number of Cigarettes Smoked in the Resist Smoking Paradigm
Tijdsspanne: During laboratory session on day 5, assessed for up to 2 hours
Participant smoking behavior will be assessed during the laboratory session using a validated smoking lapse paradigm. The primary outcome measure is number of cigarettes smoked.
During laboratory session on day 5, assessed for up to 2 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Urge to Smoke for Negative Affect Relief
Tijdsspanne: During laboratory session on day 5, assessed for up to 2 hours
The 10-item brief QSU (QSU-B) questionnaire will be used to assess smoking urges. The QSU-B contains 2 subscales (anticipation of reward, relief from negative affect). The QSU-B with a "Right Now" frame of reference will be administered before the smoking resist paradigm. Urge to smoke for negative affect relief (QSU-B Factor 2) has been linked to outcomes for the smoking resist paradigm. The range of possible scores is 4 to 28, with higher scores indicating greater urges.
During laboratory session on day 5, assessed for up to 2 hours
Number of Days Abstinent From Cigarettes During Monitored Abstinence Period
Tijdsspanne: Assessed during 7-day monitored abstinence period during study days 6 - 12
Number of days of biochemically verified abstinence during the monitoring period will be recorded.
Assessed during 7-day monitored abstinence period during study days 6 - 12

Medewerkers en onderzoekers

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

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 (Werkelijk)

1 november 2015

Primaire voltooiing (Werkelijk)

31 maart 2018

Studie voltooiing (Werkelijk)

31 maart 2018

Studieregistratiedata

Eerst ingediend

17 november 2015

Eerst ingediend dat voldeed aan de QC-criteria

3 december 2015

Eerst geplaatst (Schatting)

8 december 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 maart 2019

Laatste update ingediend die voldeed aan QC-criteria

27 februari 2019

Laatst geverifieerd

1 februari 2019

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 823413

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