メタンフェタミン使用障害に対する加速 TMS プロトコルのテスト
The investigators will evaluate the effects of an accelerated Transcranial Magnetic Stimulation (TMS) protocol of the left dorsolateral prefrontal cortex (DLPFC) for moderate to severe methamphetamine use disorder. This is a randomized parallel group design to assess feasibility and safety, evaluate efficacy (use, craving) and identify magnetic resonance imaging (resting state and cue craving) associated with group/outcomes.
調査の概要
詳細な説明
In a randomized double-blind parallel-group sham-controlled design (n=20) administer a 5-day accelerated iTBS protocol (40 treatments) to the left dorsolateral prefrontal cortex during a short inpatient stay. Magnetic resonance imaging will be completed pre-post TMS and participants will be followed for 12 weeks.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Anschutz Medical Campus
-
-
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:
- Age 21-65 years inclusive;
- Meets DSM-5 criteria for past-year moderate or severe methamphetamine use disorder;
- By Timeline Follow Back endorses at least 10 days of methamphetamine use out of the last month;
- Provides a urine drug screen positive for methamphetamine;
- Able to provide informed consent;
- No change in current psychiatric medication regimen, or medication free, for at least 4 weeks prior to study entry;
- Adequate English proficiency for study consent, and completion of the study instruments.
Exclusion Criteria:
- Lifetime non-substance-induced psychotic disorders, schizophrenia, schizoaffective disorder or bipolar disorder defined by DSM-5;
- Current diagnosis of DSM-5 drug use disorder other than stimulant, cannabis or nicotine use disorder;
- Non-substance-induced manic episode within the past 3 years or major depressive episode in the past year;
- Current clinically significant neurological disorder or medical illness, including history of seizures, cardiovascular disease/cardiac event, which in the opinion of the study physician would make study participation unsafe;
- Presence of a clinically significant abnormality on baseline MRI;
- Inability to have an MRI;
- Currently breastfeeding, is currently pregnant or lack of use of effective contraception in women of childbearing age, as assessed by urine pregnancy test and self-report (participants will consent to continue effective contraceptives during the study);
- Active criminal justice involvement (i.e., any unresolved legal problems that could jeopardize continuation or completion of the study);
- History of head injury with loss of consciousness for more than 15 minutes;
- Diagnosis of dementia;
- Prescribed benzodiazepines or anticonvulsants;
- Currently enrolled in formal substance use disorder treatment;
- Metal implants or non-removable metal objects above the waist;
- Lifetime history of prior clinical treatment with TMS;
- Serious risk of suicide or homicide;
- Unable/unwilling to follow the study procedures;
- History of intractable migraine;
- Assessed to be at risk for alcohol or opioid withdrawal.
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：Sham TMS
Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of sham TMS, and then have weekly study visits for the next 12 weeks. |
The TMS Cool-B65 A/P coil on its placebo side delivers electrical stimulation to the scalp (e.g., mimicking sensations associated with real stimulation) but does not provide magnetic stimulation to the targeted cortical structure. |
|
実験的：Active TMS
Participants have baseline assessments/evaluation, are admitted to the inpatient research unit, randomized via permuted block design to 5 days of active TMS, and then have weekly study visits for the next 12 weeks. |
The TMS Cool-B65 A/P coil delivers magnetic stimulation to targeted cortical structure. |
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 |
|---|---|---|
|
Tolerability
時間枠：5 days
|
Proportion completing at least 20 TMS session - sham vs. active |
5 days
|
|
Study emergent adverse events
時間枠：12 weeks
|
Incidence of study emergent adverse events - sham vs. active |
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weeks of continuous abstinence
時間枠：12 weeks
|
Number of weeks of continuous methamphetamine abstinence - sham vs. active as measured weekly by urine drug screen. |
12 weeks
|
|
Days of methamphetamine use
時間枠：12 weeks
|
Number of days of methamphetamine use - sham vs. active as measured weekly by timeline followback interview. |
12 weeks
|
|
Time to first methamphetamine use
時間枠：12 weeks
|
Time from end of TMS treatment to first methamphetamine use by timeline follow back or urine drug screen |
12 weeks
|
|
Methamphetamine craving
時間枠：12 weeks
|
Craving as measured on the Stimulant Craving Questionnaire-Brief - sham vs. active. Each item is scored 0-6 (from Strongly Disagree=0 to Strongly Agree=6) with items #4 and #7 reverse scored. The investigators will average all 10 items as the total score, with higher scores indicating greater levels of craving. |
12 weeks
|
|
Methamphetamine craving on visual analog scale
時間枠：12 weeks
|
Craving as measured on visual analog scale - sham vs. active. Scored 0 to 100 with 0=no craving and 100=the most craving. |
12 weeks
|
|
MRI cue craving
時間枠：Pre- and Post- TMS stimulation in week 1
|
Cue craving data will be collected pre- and post-TMS stimulation in week 1 |
Pre- and Post- TMS stimulation in week 1
|
|
MRI resting state
時間枠：Pre- and Post- TMS stimulation in week 1
|
Resting state data will be collected pre- and post-TMS stimulation in week 1 |
Pre- and Post- TMS stimulation in week 1
|
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 (推定)
研究の完了 (推定)
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
本研究に関する用語
その他の研究ID番号
- 23-1044
- K24DA058882 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
No plan to share IPD.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。