Nicotine WithdrawalPhase 1tDCSsmokersNCT01567982
Effects of Transcranial Direct Current Stimulation on Tobacco Withdrawal Symptoms
A Phase 1 study testing tDCS, prefrontal cortex and parietal cortex in people with Nicotine Withdrawal and Tobacco Abstinence, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Withdrawal, Tobacco Abstinence
- What is being tested?
- tDCS, prefrontal cortex and parietal cortex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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
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- 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)
- For subjects participating in the smoking portion, consumption of more than 10 standard drinks of alcohol per week (see inclusion criteria for description of standard drink)
- 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)
- Smokers group:
- Has not smoked 15 or more cigarettes per day for a minimum of the past 2 years
- A CO breath sample of <15 ppm during any session (except the abstinence session)
- Presence of a pacemaker, catheter or device implant that might be interfered with by the current applied during tDCS.
- Eligibility to participate in the study will be determined by trained research personnel who will screen potential participants over the phone.
- Minors are excluded because the study involves cigarette smoking. Participants over 55 are excluded due to their increased probability of smoking-related and age-related health problems. Pregnant women or those of childbearing potential who are not using birth control will be excluded because the studies involve cigarette smoking and therefore pose a risk to a fetus.
Trial locations and contacts
1 site in 1 country.
United States1 site
1 Church Street, Room 729
New Haven, Connecticut, 06510
About this study
Official title: Phase 1 Study of Effects of tDCS on Tobacco Withdrawal Symptoms
We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours.
Read the detailed description
We will recruit 35 non-smokers and 30 adult smokers who smoke > 15 cigarettes/day for more than two years and are 18-55 years old. We expect about half of them will be females. All participants will be screened for drugs of abuse and female participants will receive a pregnancy test. Each smoker will participate in four tDCS sessions, one for sham and three for real tDCS, each for one set of electrode montage. The first set is dorsal lateral prefrontal cortex (i.e., F3 and F4 of 10/20 EEG system) and neck. The second set is middle line prefrontal cortex (Fz), superior parietal cortex (Pz), and bilateral inferior temporal cortex (T3 and T4). The third set is left dorsal lateral prefrontal cortex (F3) and superior parietal cortex (P1), and right inferior temporal cortex (T4). The sequence of real and sham tDCS will be counterbalanced among participants. Each session will last for 20 minutes and there will be a minimum 48 hours between the two sessions. Participants will be required to be abstinent from cigarette smoking overnight for a minimum of 10 hours and arrive at our lab around 8:30 AM for each tDCS session. After arrival, each participant will provide a breath sample for detection of any alcohol in their system, an assay of CO and for verification of abstinence from cigarette smoking. We will place a nicotine patch (Nicoderm with 21 mg nicotine) on the back of participants. We will also ask each participant to chew a nicotine gum (Nicorette gum with 4 mg nicotine) for 30 minutes. The participants will perform a battery of computerized tasks including the N-Back working memory task, and an attention task involving watching a computer screen and pressing buttons to indicate more odd or even numbers displayed on the screen. In addition participants will complete the following questionnaires related to mood, nicotine withdrawal, mental state, possible side effects, and cigarette craving: Profile of Mood States (McNair et al 1971), Shiffman-Jarvik Withdrawal Scales (Shiffman \& Jarvik 1976), and Urge To Smoke (Jarvik et al 2000), tDCS side effects questionnaire, Wisconsin Smoking Withdrawal Scale (Welsch 1999), Perceived Stress Scale (Cohen 1983), Spielberger State/Trait Anxiety Questionnaire (Spielberger 1970).
Each participant will repeat above battery of cognitive tasks and questionnaires after tDCS. Then they will be instructed to smoke one cigarette after this second battery of tasks/questionnaires, and repeat the second battery of questionnaires after cigarette smoking.
- Conditions
- Nicotine Withdrawal, Tobacco Abstinence
- Being tested
- tDCS, prefrontal cortex and parietal cortex
- Keywords
- tDCS, brain stimulation, addiction, substance dependence, craving, cognition
- Medical subject headings
- Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS, prefrontal cortex and parietal cortexDevice
Also called transcranial direct current stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| smokers and nonsmokers | Experimental | both smokers and nonsmokers will receive same tDCS Receives: Device: tDCS, prefrontal cortex and parietal cortex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urge to Smoke scale
This is a 10-item self-report questionnaire. It measures the level of urge to smoke cigarette
Measured: 20 minutes
Negative affect
Use self-report questionnaire Profile of Mood States to assess negative affect
Measured: 10 min
Secondary outcomes (1)
Reaction time on an attention task
Participants will perform a computerized visual attention task. Performance measures including reaction time and accuracy.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine WithdrawalStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jiansong Xu, Yale University
- Investigators
- Jiansong Xu, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567982
- Sponsor's protocol ID
- 1008007212
- Other IDs
- K01DA027750
- Acronym
- tDCSsmokers
- Status last verified
- Jul 2015
- First submitted
- 28 Mar 2012
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Effects of tDCS on Tobacco Withdrawal Symptoms
- ClinicalTrials.gov ID
- NCT01567982
- Acronym / sponsor ID
- tDCSsmokers / 1008007212
- Conditions
- Nicotine Withdrawal, Tobacco Abstinence
- Keywords
- tDCS, brain stimulation, addiction, substance dependence, craving, cognition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 30 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that transcranial direct current stimulation will reduce tobacco withdrawal symptoms of tobacco dependent smokers abstinent from smoking for more than 10 hours.
Detailed description
We will recruit 35 non-smokers and 30 adult smokers who smoke > 15 cigarettes/day for more than two years and are 18-55 years old. We expect about half of them will be females. All participants will be screened for drugs of abuse and female participants will receive a pregnancy test. Each smoker will participate in four tDCS sessions, one for sham and three for real tDCS, each for one set of electrode montage. The first set is dorsal lateral prefrontal cortex (i.e., F3 and F4 of 10/20 EEG system) and neck. The second set is middle line prefrontal cortex (Fz), superior parietal cortex (Pz), and bilateral inferior temporal cortex (T3 and T4). The third set is left dorsal lateral prefrontal cortex (F3) and superior parietal cortex (P1), and right inferior temporal cortex (T4). The sequence of real and sham tDCS will be counterbalanced among participants. Each session will last for 20 minutes and there will be a minimum 48 hours between the two sessions. Participants will be required to be abstinent from cigarette smoking overnight for a minimum of 10 hours and arrive at our lab around 8:30 AM for each tDCS session. After arrival, each participant will provide a breath sample for detection of any alcohol in their system, an assay of CO and for verification of abstinence from cigarette smoking. We will place a nicotine patch (Nicoderm with 21 mg nicotine) on the back of participants. We will also ask each participant to chew a nicotine gum (Nicorette gum with 4 mg nicotine) for 30 minutes. The participants will perform a battery of computerized tasks including the N-Back working memory task, and an attention task involving watching a computer screen and pressing buttons to indicate more odd or even numbers displayed on the screen. In addition participants will complete the following questionnaires related to mood, nicotine withdrawal, mental state, possible side effects, and cigarette craving: Profile of Mood States (McNair et al 1971), Shiffman-Jarvik Withdrawal Scales (Shiffman \& Jarvik 1976), and Urge To Smoke (Jarvik et al 2000), tDCS side effects questionnaire, Wisconsin Smoking Withdrawal Scale (Welsch 1999), Perceived Stress Scale (Cohen 1983), Spielberger State/Trait Anxiety Questionnaire (Spielberger 1970).
Each participant will repeat above battery of cognitive tasks and questionnaires after tDCS. Then they will be instructed to smoke one cigarette after this second battery of tasks/questionnaires, and repeat the second battery of questionnaires after cigarette smoking.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| smokers and nonsmokers | Experimental | Device: tDCS, prefrontal cortex and parietal cortexboth smokers and nonsmokers will receive same tDCS |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS, prefrontal cortex and parietal cortexAlso: transcranial direct current stimulationtDCS 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. | Device | smokers and nonsmokers |
Primary outcome
Urge to Smoke scale
Time frame: 20 minutes
This is a 10-item self-report questionnaire. It measures the level of urge to smoke cigarette
Negative affect
Time frame: 10 min
Use self-report questionnaire Profile of Mood States to assess negative affect
1 secondary outcome
Reaction time on an attention task
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
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Circuit Breathing Exercise on Smoking Cessation Among Youth E-Cigarette Users
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Overcoming Nicotine Dependence to Enable Quitting
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Evaluation of Dependence and Nicotine Replacement Therapy-Supported Cessation Efforts Among Regular Electronic Cigarette Use
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiansong Xu, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tDCS, prefrontal cortex and parietal cortex in people with Nicotine Withdrawal and Tobacco Abstinence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urge to Smoke scale (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2015.