- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02624284
tDCS Effects on Resisting Smoking: Dose Ranging Study (RDR)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore fittizio: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Resisting Smoking - Time to First Cigarette in the Resist Smoking Paradigm
Lasso di tempo: During laboratory session on day 5, assessed for up to 2 hours
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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
Lasso di tempo: During laboratory session on day 5, assessed for up to 2 hours
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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.
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During laboratory session on day 5, assessed for up to 2 hours
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Urge to Smoke for Negative Affect Relief
Lasso di tempo: 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.
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During laboratory session on day 5, assessed for up to 2 hours
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Number of Days Abstinent From Cigarettes During Monitored Abstinence Period
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 823413
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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