Effects of Stimulant Medications in PTSD (SMP)
2026年6月18日 更新者：University of Chicago
While there have been advances in understanding post-traumatic stress disorder (PTSD) as a disorder and its biological features, unfortunately only one out of five traumatized persons with PTSD reach remission after cycling through evidence-based and/or FDA-approved medications.
This is especially unfortunate given that people with PTSD are often from vulnerable populations, or those whose professions entail personal sacrifice.
It is clear that new serotonergic antidepressants and atypical antipsychotics will not be sufficient to fix this gap, and new mechanisms of action need to be tested.
In the current proposal, the investigators test the hypothesis that mixed amphetamine salts (brand name Adderall), FDA-approved for treating attention deficit hyperactivity disorder (ADHD), can improve PTSD outcomes.
調査の概要
詳細な説明
Post-traumatic stress disorder is a debilitating neuropsychiatric condition triggered by exposure to a traumatic exposure.
Approximately 8% of the US population will experience the condition in their lifetime.
At-risk populations, such as those exposed to community violence or warfare, have nearly double the risk.
Despite progress in recognizing that PTSD is a disorder of neural circuits that underlie how individuals learn from the world, available treatments, including two FDA-approved medications (serotonergic antidepressants) and gold-standard evidence-based psychotherapies, help only one in five individuals reach remission.
One key aspect of PTSD is difficulty in engaging in social interactions.
Based on surprising evidence published in peer-reviewed manuscripts from our research programs at The University of Chicago, medications used to treat ADHD have positive effects on social interaction.
Combined with promising data from biological studies of PTSD, psychostimulants used to safely treat ADHD such as Adderall (generic: mixed amphetamine salts), can help people with PTSD re-engage in social relationships that are the key to their recovery.
This study will test the hypothesis that mixed amphetamine salts will acutely increase social interaction in adults with PTSD compared to placebo in a novel laboratory-based social interaction task.
研究の種類
介入
入学 (推定)
40
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hanna Molla
- 電話番号：7737023560
- メール：hmolla@uchicago.edu
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637
- University of Chicago
-
コンタクト：
- Hanna Molla
- 電話番号：7737023560
- メール：hmolla@uchicago.edu
-
主任研究者：
- Royce Lee
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Age 18 - 65 years old
- BMI 19-30 kg/m2
- English fluency
Exclusion Criteria:
- Individuals with current moderate or severe substance use disorder, no past stimulant or cocaine use disorder
- Individuals with current acute or high risk of suicide or suicide attempt in past 6 months
- Individuals with current psychotic or bipolar disorder
- Individuals with past schizophrenia, schizoaffective disorder, psychotic bipolar disorder, stimulant or cocaine use disorder
- Individuals with chronic (non-PRN) treatment with antipsychotic drug (except PRN quetiapine 25mg PO qHS) or D2 antagonist
- Individuals with medications with significant PD or PK interactions
- Individuals with current treatment with a stimulant medication
- Individuals with court or legally mandated treatment
- Individuals with unstable or untreated medical disorder that would increase the risk of serious side effects of study drug (unstable hypertension, tachycardia, cardiac arrhythmia, recent MI or stroke, clinically significant neuropsychiatric or neurological disorder)
- Members of a vulnerable population
- High blood pressure (>140/90)
- Women who are pregnant, breastfeeding, or planning to become pregnant
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：クロスオーバー割り当て
- マスキング：ダブル
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：placebo
dextrose
|
dextrose
|
|
実験的：Adderall
Adderall (20 mg)
|
mixed amphetamine salts
|
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 |
|---|---|---|
|
Quality of Social Interaction Ratings using the Conversation Questionnaire
時間枠：Completed 4 hours post-drug administration during both sessions (drug, placebo)
|
6 items on a 9 point Likert scale.
Higher scores indicate increased quality of social interactions
|
Completed 4 hours post-drug administration during both sessions (drug, placebo)
|
|
Quality of Social Interaction Ratings using connection during conversation scale
時間枠：Completed 4 hours post-drug administration during both sessions (drug, placebo)
|
9 point Likert scale with 16 items.
Includes subscales: conversation enjoyment, perceived meaningfulness, and feelings of interpersonal connection.
Higher scores indicate increased quality of social interactions
|
Completed 4 hours post-drug administration during both sessions (drug, placebo)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月15日
一次修了 (推定)
2027年9月15日
研究の完了 (推定)
2027年9月15日
試験登録日
最初に提出
2026年6月15日
QC基準を満たした最初の提出物
2026年6月18日
最初の投稿 (実際)
2026年6月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月24日
QC基準を満たした最後の更新が送信されました
2026年6月18日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB25-1935
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?
未定
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
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
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