- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02624284
tDCS Effects on Resisting Smoking: Dose Ranging Study (RDR)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy males and females who are between 18 and 60 years of age
- Report smoking at least 10 cigarettes per day for the past year and have a CO value of > 10ppm at intake
- Planning to live in the area for at least the next 2 months;
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
- Able to communicate fluently in English (speaking, writing, and reading);
- Smokers who answer yes on a question regarding motivation to quit smoking.
Exclusion Criteria:
Alcohol/Drugs:
- History or current diagnosis or treatment for alcohol or drug abuse (as reported during phone screen);
- 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:
- Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix);
- Anti-psychotic medications;
- Nicotine replacement therapy (NRT);
- GABAergic medications;
- Glutamatergic medications;
Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician.
Daily use of:
- Opiate-containing medications for chronic pain;
- Benzodiazepines.
Medical/Neuropsychiatric:
- 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);
- History of epilepsy or a seizure disorder;
- History of stroke;
- Self-reported history of brain or spinal tumor;
- 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:
- Self-report of metallic objects in the face or head other than dental apparatus (e.g. braces, fillings, and implants);
- Self-report of pacemakers or implantable cardioverter-defibrillator (ICD).
- Self-report of any skull fracture or opening.
General Exclusion:
- Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator;
- 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;
- Inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Sham-komparator: 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.
Andre navne:
|
Eksperimentel: 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.
Andre navne:
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Resisting Smoking - Time to First Cigarette in the Resist Smoking Paradigm
Tidsramme: 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.
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During laboratory session on day 5, assessed for up to 2 hours
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Resisting Smoking - Number of Cigarettes Smoked in the Resist Smoking Paradigm
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Urge to Smoke for Negative Affect Relief
Tidsramme: 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
Tidsramme: Assessed during 7-day monitored abstinence period during study days 6 - 12
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Number of days of biochemically verified abstinence during the monitoring period will be recorded.
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Assessed during 7-day monitored abstinence period during study days 6 - 12
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 823413
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