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NCT01031693 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT01031693 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 75 participants.
The verdict
NCT01031693, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
Background: * Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings. * Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether TMS delivered in single pulses can decrease activity in the parts of the brain that respond to nicotine craving. Objectives: \- To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in cigarette smokers. Eligibility: * Individuals 18 years of age and older who are physically healthy and have smoked 10 or more cigarettes per day for at least 1 year. * A small group of healthy nonsmoking control subjects 18 years of age and older will also participate in the study. Design: * The study will involve seven study visits and two follow-up visits. The control participants will have only two visits: one with a magnetic resonance imaging (MRI) scan and one with TMS to evaluate brain function and response. * Participants will have an initial assessment about tobacco use habits and craving patterns, and will provide blood and urine samples before beginning the study. * Participants will have two initial MRI brain scans. The first scan will look at the structure of the brain at rest. During the other scan, participants will look at images related to and not related to cigarette smoking. * The single pulse TMS sessions (with either actual TMS or inactive \[sham\] TMS) will be held daily for 5 consecutive days. Magnetic pulses will be triggered by cigarette-related picture cues and delivered at varying intervals before the participant sees a cigarette-related picture. During these testing visits, researchers will ask questions related to tobacco use and craving, and collect urine and breath samples for further stu
Interventions
- DEVICE Transcranial Magnetic Stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2009-07-13 |
| Est. Completion | 2013-08-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01031693
The ClinicalTrials.gov registry entry for NCT01031693 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Transcranial Magnetic Stimulation is the first listed.
NCT01031693 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01031693 about?
NCT01031693 is a clinical study titled "Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction". Background: * Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings. * Transcranial magnetic stimulation (TMS) uses magnetic...
What is the current status of trial NCT01031693?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2009-07-13. Estimated completion is 2013-08-28.
What interventions are being tested in trial NCT01031693?
The interventions under investigation include: Transcranial Magnetic Stimulation (DEVICE).
Who is sponsoring clinical trial NCT01031693?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
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