TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence

Nicotine Dependence Clinical Trial

— TDCSNIC  

Official title:

Transcranial Direct Current Stimulation (TDCS) and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534454
• Other study ID #: 20547
• Secondary ID: R21DA037546
• Status: Completed
• Phase: N/A
• Start date: August 15, 2015
• Est. completion date: March 31, 2018

Study information

• Verified date: May 2018
• Source: The Mind Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the phase 1 translational pilot study proposed here is to gather preliminary data investigating the efficacy of transcranial direct current stimulation (TDCS) and cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The recent use of TDCS over task relevant regions to alter behavior holds incredible promise for use in cognitive retraining intervention protocols. Previous studies of cognitive retraining have focused on implicit training techniques. This proposed study will attempt to enhance these implicit training techniques through the use of TDCS during implicit retraining in order to increase learning of avoidance-related action tendencies towards tobacco. The objective of this pilot study is to establish the feasibility and obtain preliminary data on the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette smoking in individuals with nicotine addiction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Consume 10 or more cigarettes/day average for the past 60 days

• Able to provide informed consent

• Less than 3 months smoking abstinence in the past year

• Right Handed

Exclusion Criteria:

• Serious medical illness within 6 months (e.g. cancer, hepatic, or renal disease)

• Significant cardiovascular disease (e.g. recent stroke or heart attack, arrhythmias, worsening angina pectoris, uncontrolled hypertension) generalized skin disorders, or sensitivity to the nicotine patch

• Use of illicit drugs (excluding marijuana) in the previous 30 days

• Psychosis, psychotic disorder, or bipolar disorder

• Current active major depression (depressive episode within last month)

• Clinically significant suicidal ideation

• Prior seizure

• Current bupropion or tricyclic antidepressants

• Current pregnancy, trying to become pregnant, or breastfeeding

• Current active alcohol dependence (symptoms in last 30 days)

• Left-handedness

• Current medication known to interact with nicotine replacement therapy (NRT) or smoking cessation (e.g. adenosine, cimetidine, conivaptan, cyproterone, peginterferon alfa-2bg, tocilizumab, theophylline)

• Metal in the head

• Implanted brain medical devices

• Electromedical devices

• Latex Allergy

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Active Retraining

• Sham Retraining

Device:
• Active transcranial direct current stimulation (TDCS)

• Sham transcranial direct current stimulation (TDCS)

Drug:
• Nicotine Replacement Therapy (Habitrol)
Administration of Nicotine Replacement Therapy Patches

Locations

Country	Name	City	State
United States	The Mind Research Network	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
The Mind Research Network	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarettes per Smoking Day	Number of cigarettes consumed per day will be assessed using the Timeline Follow-back method to obtain the number of cigarettes consumed on each day since the last administration of the Timeline Follow-back. Cigarettes per smoking day will be the mean number of cigarettes consumed on days on which cigarettes were consumed.	11-Weeks Post-transcranial direct current stimulation (TDCS)/Retraining
Secondary	Approach Bias Towards Cigarettes (Measure of response time differences)	Measure of response time differences to push vs. pull a joystick in response to pictures of cigarettes vs. control objects (e.g. pens)	1 week Post-transcranial direct current stimulation (TDCS)/Retraining