Nicotine TMS EFT Smoking Pilot Study
Theta-Burst Stimulation As A Tool To Change Smoking Behavior
調査の概要
詳細な説明
The purpose of this study is to develop theta burst transcranial magnetic stimulation (tbTMS) as a potential treatment for nicotine addiction. Theta burst TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether tbTMS over the forehead can produce a reduction in things that may prompt individuals to want to smoke cigarettes. TMS has been approved by the Food and Drug Administration as an investigational tool as well as a therapy for depression. However, TMS is not approved by the Food and Drug Administration as a treatment for nicotine cravings and other addictions.
This study consists of one consent session and one TMS session. Participants will be asked to complete a series of questionnaires and computer assessments about nicotine both before and after a single tbTMS session.
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 18-65 years of age
- Smoke at least 10 cigarettes a day (on average)
- Not be pregnant
- Meet all criteria on a standardized TMS safety screen (including to but not limited to implanted electronic devices, bullets or metallic fragments above the neck, hair clips that cannot be removed)
- No barriers to making contact between the TMS coil and the skin (e.g. cornrows that cannot be removed, glasses that the participant is unwilling to remove)
Exclusion Criteria:
- Report comorbid mental or physical illness (managed or unmanaged)
- Currently using prescription medication that might affect smoking or nicotine metabolism
- Using smokeless tobacco or alternative nicotine products
- History of epilepsy or seizures (other than childhood febrile seizures)
- History of chronic migraines
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Real cTBS to MPFC
One session of real cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total).
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This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key).
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偽コンパレータ：Sham cTBS to MPFC
One session of sham cTBS treatment delivered to the medial prefrontal cortex (MPFC) (2 trains of stimulation over the MPFC as defined by EEG coordinates (FP1); each train: 120 sec, 3 pulse bursts presented at 5Hz, 15 pulses/sec, 1800 pulses/train, 60 sec intertrain interval; 110% RMT, MagPro X100 Cool Coil; 3600 pulses total).
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This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key).
The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in craving after a single session of cTBS
時間枠：For the duration of the study, approximately 24 hours following real or sham cTBS
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The effect of real versus sham cTBS on nicotine craving will be assessed by comparing pre-TMS and post-TMS changes in nicotine craving scores.
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For the duration of the study, approximately 24 hours following real or sham cTBS
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in delayed discounting after a single session of cTBS
時間枠：For the duration of the study, approximately 24 hours following real or sham cTBS
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The effect of real versus sham cTBS on nicotine craving will be assessed by comparing pre-TMS and post-TMS changes in delayed discounting scores.
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For the duration of the study, approximately 24 hours following real or sham cTBS
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。