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Nicotine DependencePhase 2rTMSNCT00901459

A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers

A Phase 2 study testing Active rTMS Condition in people with Nicotine Dependence, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) to block craving for cigarettes in smokers. rTMS is an investigational procedure, where a device called a "stimulator" provides electricity to a device that creates a magnetic field. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Nicotine Dependence
What is being tested?
Active rTMS Condition
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
May 2009to Aug 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 18 to 50 years of age;
  • dependent smoker of > 10 cigarettes per day of cigarettes yielding >0.5mg nicotine (by Federal Trade Commission rated yields);
  • have smoked cigarettes for at least three cumulative years;
  • an afternoon carbon monoxide reading of at least 10ppm;
  • be in general good health based on physical examination, EKG, serum chemistries, CBC, and urinalysis and
  • show evidence of greater craving following exposure to in vivo smoking versus control cues

Who cannot join

  • Individuals with a clinically defined neurological disorder or insult including, but not limited to, any condition likely to be associated with increased intracranial pressure;
  • space occupying brain lesion;
  • any history of seizure EXCEPT those therapeutically induced by ECT (Electro Convulsive Therapy);
  • history of cerebrovascular accident;
  • transient ischemic attack within two years;
  • cerebral aneurysm;
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  • dementia;
  • Parkinson's disease;
  • Huntington's chorea;
  • multiple sclerosis;
  • current lung disease or lung disorder;
  • hypertension (systolic >140 mmHg, diastolic > 90 mmHg);
  • hypotension (< 90 mmHg, diastolic < 60 mmHg);
  • coronary artery disease;
  • cardiac rhythm disorder;
  • impaired hepatic or renal function (based on documented diagnosis or abnormal chemistries) except gallstones or kidney stones;
  • other major medical or psychiatric condition;
  • use of any concurrent hypertensive, psychiatric, or psychoactive medication;
  • any concurrent medication that lowers seizure threshold;
  • smokeless tobacco, pipe, or cigar use in the past 30 days;
  • nicotine replacement therapy, or other smoking cessation therapy within the past 30 days;
  • increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for > 5 minutes;
  • ECT treatment within 3 months prior to screening visit;
  • failure to respond to ECT treatment (i.e., consistent with ATHF level 2 or higher);
  • a true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire;
  • history of treatment with rTMS therapy for any disorder;
  • use of any investigational drug within 30 days of the screening visit;
  • history of treatment with Vagus Nerve Stimulation;
  • use of any medication(s) with active CNS properties within 1 week of the screening visit;
  • cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease; intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
  • known or suspected pregnancy;
  • positive urine drug screen or reported drug abuse in the past 30 days;
  • clinically significant laboratory abnormality, in the opinion of the investigator or study physician;
  • women who are breast-feeding; women of child-bearing potential not using a medically accepted form of contraception when engaging in sexual intercourse;
  • current chronic pain or other pain condition that interferes with daily activities or requires use of prescription medication;
  • claustrophobia or abnormal fear of cramped or confined space;
  • Individuals where a motor threshold response is not elicited with stimulation at or below 80% of maximum output;
  • active ulcer within the past 30 days;
  • frequent migraines (great than four in the past 30 days);
  • Females who score greater than or equal to 13 and males who score greater than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification Test)will be excluded from the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Center for Nicotine & Smoking Cessation Research

    Durham, North Carolina, 27705

Other trials in United States

About this study

The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) to block craving for cigarettes in smokers. rTMS is an investigational procedure, where a device called a "stimulator" provides electricity to a device that creates a magnetic field. This device is placed against the scalp in the front of the head so that the magnetic field is focused on an area of the brain that is thought to be involved in craving for cigarettes. rTMS is an investigational procedure so therefore being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA). Changes in magnetic fields during rTMS administration change electrical currents which may affect brain activity and function.

Read the detailed description

The goal of this study is to evaluate the effects of rTMS on cue-induced craving in dependent smokers. We hypothesize that low frequency rTMS over the SFG will block cue-induced craving. In order to test this hypothesis, subjects will undergo three conditions:

  1. active condition: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues
  2. location control condition: low frequency rTMS was administered over motor cortex (MC) during the presentation of smoking and control cues
  3. frequency control condition: high frequency rTMS was administered over the SFG during the presentation of smoking and control cues
Being tested
Active rTMS Condition, rTMS Location Control Condition, rTMS Frequency Control Condition
Keywords
Repetitive Transcranial Magnetic Stimulation, Cigarette Smoker, Cigarette Dependence, To block cue-elicited craving in dependent cigarette smokers
Medical subject headings
Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active rTMS ConditionDevice

    Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.

  • rTMS Location Control ConditionDevice

    Low frequency rTMS (90% Motor Threshold at 1 HZ) will be administered over the motor cortex (MC) during the presentation of smoking and control cues.

  • rTMS Frequency Control ConditionDevice

    High frequency rTMS (90% Motor Threshold at 10 HZ) will be administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues.

Study groups in NCT00901459
Study groupRoleWhat they receive
rTMS 90% MT - Low frequency rTMSActive comparatorIntervention type: device. Intervention description: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues using 90% MT (Motor Threshold) 1 Hz rTMS Dose on Superior Frontal Gyrus
Receives: Device: Active rTMS Condition
Location ControlActive comparatorrTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
Receives: Device: rTMS Location Control Condition
Frequency ControlActive comparatorrTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
Receives: Device: rTMS Frequency Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.

    Cigarette craving was assessed orally during each rTMS Session, before and after each stimulus presentation and cigarette smoking with a brief version of the Shiffman-Jarvik questionnaire (14), which contained items assessing cigarette craving using the following subscale: CRAVING ("urges to smoke," "miss a cigarette," and "crave cigarettes"), MOOD ("calm," "tense," and "irritable"), AROUSAL ("wide awake," "able to concentrate"), and HUNGER ("feel hungry"). The scale for the Shiffman-Jarvik questionnaire is a Likert item scale with measurements 1-Not at All; 2-Very Little; 3-A Little; 4-Moderately; 5- A Lot; 6-Quite A Lot and 7-Extremely. The change in craving for cigarettes after smoking cues versus neutral cues using the parenthetical items listed above with the subscale CRAVING were used to determine the primary outcome. A negative value represents a decrease in reported cigarette craving.

    Measured: Following exposure to in vivo cues

Secondary outcomes (1)

  1. Change in Craving for Cigarettes After Controlled Smoke Presentations.

    Craving reduction was assessed orally by an item on the cigarette evaluation questionnaire ("Did it immediately reduce your craving for cigarettes?") after smoking presentations through the controlled puff volume apparatus.

    Measured: After smoking a cigarette through the controlled puff volume apparatus during rTMS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00901459
Sponsor's protocol ID
Pro00002339
Acronym
rTMS
Status last verified
Dec 2012
First submitted
11 May 2009
Last updated
25 Jan 2013
Data monitoring committee
Yes

Publications

  • Rose JE, McClernon FJ, Froeliger B, Behm FM, Preud'homme X, Krystal AD. Repetitive transcranial magnetic stimulation of the superior frontal gyrus modulates craving for cigarettes. Biol Psychiatry. 2011 Oct 15;70(8):794-799. doi: 10.1016/j.biopsych.2011.05.031. Epub 2011 Jul 18.

    PubMed 21762878

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Active rTMS Condition in people with Nicotine Dependence, run by Duke 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 6 inclusion and 40 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 25 Jan 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design. (time frame: Following exposure to in vivo cues). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00901459, which also lists 1 linked publication.

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 25 Jan 2013; AzTrials last refreshed its copy on 6 Nov 2026.

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