Effects of Transcranial Direct Current Stimulation on Tobacco Withdrawal Symptoms

NCT01567982 | Completed Phase 1

• 2 other identifiers: 1008007212K01DA027750
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours.

Conditions

Nicotine Withdrawal; Tobacco Abstinence

Keywords

tDCS; brain stimulation; addiction; substance dependence; craving; cognition

Outcome Measures

Primary Outcomes (2)

• Urge to Smoke scale

  This is a 10-item self-report questionnaire. It measures the level of urge to smoke cigarette

  20 minutes

• Negative affect

  Use self-report questionnaire Profile of Mood States to assess negative affect

  10 min

Secondary Outcomes (1)

• Reaction time on an attention task

  20 minutes

Study Arms (1)

smokers and nonsmokers

EXPERIMENTAL

both smokers and nonsmokers will receive same tDCS

Device: tDCS, prefrontal cortex and parietal cortex

Interventions

tDCS, prefrontal cortex and parietal cortex DEVICE

tDCS is a non invasive brain stimulation methods. We will use two anodes to stimulate prefrontal and/or parietal cortex using 2mA current for 20 minutes.

Also known as: transcranial direct current stimulation

smokers and nonsmokers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general health
• Age between 18 and 55 yrs
• Smokers must smoke at least 15 cigarettes per day for the past two years (as indicated by self-report)
• Must give a breath CO sample of at least 15 ppm to verify current tobacco consumption during screen
• Must give a breath CO sample of 7 or less ppm to verify tobacco abstinence during the abstinence session
• Cocaine and alcohol patients should meet DSM-IV criteria, and is confirmed after clinical interview with a structured interview with the SCI-PG and SCID-P.
• Right-handed, as indicated by the Edinburgh Handedness Questionnaire
• Smokers should have no illicit drug use, as indicated by negative results on urine drug screens of cocaine, methamphetamine, opiates, or benzodiazepines at all sessions
• Smokers should consume less than or equal to 10 standard drinks of alcohol per week (one standard drink consists of one 12 oz. beer, 6 oz. of wine, or one shot (1.5 oz.) of hard liquor (80 proof) (as indicated by self-report)
• Absence of any past or current DSM-IV Axis I diagnoses (as verified by the SCID)
• English as a first language (subjects may be bilingual), and able to read and speak English fluently (as indicated by self-report)

You may not qualify if:

• Any medically significant acute or chronic medical condition as indicated by self-report (significance is determined by the P.I.)
• English as a second language (as indicated by self-report)
• Left-handed or ambidextrous as indicated on the Edinburgh Handedness Questionnaire
• Marijuana use of greater than one joint once per week. The subject's urine must screen negative at each session, so the subject is instructed to refrain from using marijuana for the 72 hours prior to each session.
• Pregnant, as indicated by a positive result on the urine pregnancy test given at each session
• Below normal intelligence (Shipley estimated IQ of 85 or less) as indicated by a combined score of \<45 on the Shipley Institute of Living Scale
• Evidence of head injury involving loss of consciousness for 5 minutes or more and/or requiring hospitalization (as indicated by self-report)
• Depression, as assessed by the SCID or a score of \>18 on the BDI (see appendix)
• Probable childhood ADHD as indicated by a score of \>46 on the Wender Utah Rating Scale and/or by self-report
• Self-report of learning disability or dyslexia
• Current or past use of psychotropic drugs (i.e., any antidepressants, antipsychotics, psychostimulants (i.e. Ritalin), benzodiazepines (i.e., Valium, Xanax), or use of any other drugs known to affect cognitive functioning (as indicated by self-report).
• HIV positive (as indicated by self-report)
• Positive TB test (as indicated by self-report)
• Presence of any past or current DSM-IV Axis I Diagnoses, as verified by the SCID
• Abnormal uncorrected vision or hearing which would affect performance on cognitive tests (as indicated by self-report)

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

1 Church Street, Room 729

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Behavior, Addictive; Substance-Related Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jiansong Xu, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 30, 2012
• Study Start: March 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2015
• Last Updated: July 15, 2015

Record last verified: 2015-07

Locations

US (1)