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

NCT02534454 | Completed DMC

• 2 other identifiers: 20547R21DA037546
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Approach Bias Towards Cigarettes (Measure of response time differences)

  1 week Post-transcranial direct current stimulation (TDCS)/Retraining

Study Arms (4)

Active TDCS + Active Retraining

EXPERIMENTAL

2.0 milliamperes (mA) of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining

Behavioral: Active Retraining; Device: Active transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol)

Sham TDCS + Active Retraining

EXPERIMENTAL

0.1 mA of transcranial direct current stimulation (TDCS) applied during active nicotine avoidance retraining

Behavioral: Active Retraining; Device: Sham transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol)

Active TDCS + Sham retraining

EXPERIMENTAL

2.0 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining

Behavioral: Sham Retraining; Device: Active transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol)

Sham TDCS + Sham Retraining

EXPERIMENTAL

0.1 mA of transcranial direct current stimulation (TDCS) applied during sham nicotine avoidance retraining

Behavioral: Sham Retraining; Device: Sham transcranial direct current stimulation (TDCS); Drug: Nicotine Replacement Therapy (Habitrol)

Interventions

Active Retraining BEHAVIORAL

Active TDCS + Active Retraining; Sham TDCS + Active Retraining

Sham Retraining BEHAVIORAL

Active TDCS + Sham retraining; Sham TDCS + Sham Retraining

Active transcranial direct current stimulation (TDCS) DEVICE

Active TDCS + Active Retraining; Active TDCS + Sham retraining

Sham transcranial direct current stimulation (TDCS) DEVICE

Sham TDCS + Active Retraining; Sham TDCS + Sham Retraining

Nicotine Replacement Therapy (Habitrol) DRUG

Administration of Nicotine Replacement Therapy Patches

Active TDCS + Active Retraining; Active TDCS + Sham retraining; Sham TDCS + Active Retraining; Sham TDCS + Sham Retraining

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Mind Research Network: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Nicotine Replacement Therapy; Nicotine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

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

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 27, 2015
• Study Start: August 15, 2015
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

US (1)