A Controlled Laboratory Study of the Effects on Cue-Induced Craving in Dependent Smokers (rTMS)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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:
- active condition: low frequency rTMS was administered over the superior frontal gyrus (SFG) during the presentation of smoking and control cues
- location control condition: low frequency rTMS was administered over motor cortex (MC) during the presentation of smoking and control cues
- frequency control condition: high frequency rTMS was administered over the SFG during the presentation of smoking and control cues
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke Center for Nicotine & Smoking Cessation Research
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: rTMS 90% MT - Low frequency rTMS
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
|
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.
|
|
Active Comparator: Location Control
rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
|
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.
|
|
Active Comparator: Frequency Control
rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Craving for Cigarettes After Smoking Cues Versus Neutral Cues Using a Repeated Measure Design.
Time Frame: Following exposure to in vivo cues
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Craving for Cigarettes After Controlled Smoke Presentations.
Time Frame: After smoking a cigarette through the controlled puff volume apparatus during rTMS
|
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.
|
After smoking a cigarette through the controlled puff volume apparatus during rTMS
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Andrew D Krystal, M.D., M.S., Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Pro00002339
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nicotine Dependence
-
NCT03194958CompletedSmoking | Smoking Cessation | Tobacco Use | Tobacco Smoking | Tobacco Use Cessation | Nicotine Dependence | Tobacco Dependence | Smoking, Tobacco | Nicotine Use Disorder | Nicotine Dependence, Cigarettes
-
NCT03194919RecruitingNicotine Dependence, Cigarettes
-
NCT03473483WithdrawnCardiovascular Risk Factor | Nicotine Dependence | Nicotine Dependence, Cigarettes | Nicotine Withdrawal | Tobacco Toxicity
-
NCT03276767RecruitingNicotine Dependence Tobacco Product
-
NCT04805515CompletedNicotine Dependence, Cigarettes
-
NCT04830384CompletedNicotine Dependence, Cigarettes
-
NCT04379388CompletedNicotine Dependence, Cigarettes
-
NCT06965296Not yet recruitingNicotine Dependence, Cigarettes
Clinical Trials on Active rTMS Condition
-
NCT01886092Unknown
-
NCT02617953Unknown
-
NCT02386969Completed
-
NCT05660018CompletedSchizophrenia | Schizophrenia Schizoaffective
-
NCT02711319Completed
-
NCT03331796CompletedCognitive Dysfunction | Mild Cognitive Impairment | Cognitive Decline | Memory Impairment | Memory Loss | Mild Neurocognitive Disorder | Mental Deterioration | Memory Decline
-
NCT05134324Active, not recruiting
-
NCT06391723Not yet recruiting