tDCS Effects on Resisting Smoking: Dose Ranging Study

NCT02624284 | Completed Results

• 1 other identifier: 823413
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nicotine Addiction

Outcome Measures

Primary Outcomes (2)

• Resisting Smoking - Time to First Cigarette in the Resist Smoking Paradigm

  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

  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

Secondary Outcomes (2)

• Urge to Smoke for Negative Affect Relief

  During laboratory session on day 5, assessed for up to 2 hours

• Number of Days Abstinent From Cigarettes During Monitored Abstinence Period

  Assessed during 7-day monitored abstinence period during study days 6 - 12

Study Arms (3)

Sham dose

SHAM COMPARATOR

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.

Device: transcranial direct current stimulation (tDCS)

1mA dose

EXPERIMENTAL

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).

Device: transcranial direct current stimulation (tDCS)

2 mA dose

EXPERIMENTAL

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).

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

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.

Also known as: tDCS, neuroConn DC-Stimulator Plus

1mA dose; 2 mA dose; Sham dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Mary Falcone, Ph.D.
• Organization: University of Pennsylvania

mfalc@pennmedicine.upenn.edu

215-746-3782

Study Officials

• Caryn Lerman, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: December 8, 2015
• Study Start: November 1, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: March 19, 2019
• Results First Posted: March 19, 2019

Record last verified: 2019-02

Locations

US (1)