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

NCT00901459 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00002339
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nicotine Dependence

Keywords

Repetitive Transcranial Magnetic Stimulation; Cigarette Smoker; Cigarette Dependence; To block cue-elicited craving in dependent cigarette smokers

Outcome Measures

Primary Outcomes (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.

  Following exposure to in vivo cues

Secondary Outcomes (1)

• Change in Craving for Cigarettes After Controlled Smoke Presentations.

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

Study Arms (3)

rTMS 90% MT - Low frequency rTMS

ACTIVE COMPARATOR

Intervention 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

Device: Active rTMS Condition

Location Control

ACTIVE COMPARATOR

rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex

Device: rTMS Location Control Condition

Frequency Control

ACTIVE COMPARATOR

rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus

Device: rTMS Frequency Control Condition

Interventions

Active rTMS Condition DEVICE

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 90% MT - Low frequency rTMS

rTMS Location Control Condition DEVICE

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.

Location Control

rTMS Frequency Control Condition DEVICE

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.

Frequency Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Center for Nicotine & Smoking Cessation Research

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 21762878 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jed E. Rose, Ph.D.
• Organization: Duke Center for Nicotine and Smoking Cessation Research

jed.rose@mc.duke.edu

919-668-5055

Study Officials

• Jed E Rose, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• Andrew D Krystal, M.D., M.S.

  Duke University

  PRINCIPAL INVESTIGATOR

• Francis J McClernon, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 13, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: January 25, 2013
• Results First Posted: January 25, 2013

Record last verified: 2012-12

Locations

US (1)