Effects of Stimulant Medications in PTSD (SMP)
18 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
40
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Hanna Molla
- Número de telefone: 7737023560
- E-mail: hmolla@uchicago.edu
Locais de estudo
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
-
Contato:
- Hanna Molla
- Número de telefone: 7737023560
- E-mail: hmolla@uchicago.edu
-
Investigador principal:
- Royce Lee
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: placebo
dextrose
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dextrose
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Experimental: Adderall
Adderall (20 mg)
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mixed amphetamine salts
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quality of Social Interaction Ratings using the Conversation Questionnaire
Prazo: Completed 4 hours post-drug administration during both sessions (drug, placebo)
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6 items on a 9 point Likert scale.
Higher scores indicate increased quality of social interactions
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Completed 4 hours post-drug administration during both sessions (drug, placebo)
|
|
Quality of Social Interaction Ratings using connection during conversation scale
Prazo: 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)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Royce Lee, MD, University of Chicago
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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- Weyandt LL, White TL, Gudmundsdottir BG, Nitenson AZ, Rathkey ES, De Leon KA, Bjorn SA. Neurocognitive, Autonomic, and Mood Effects of Adderall: A Pilot Study of Healthy College Students. Pharmacy (Basel). 2018 Jun 27;6(3):58. doi: 10.3390/pharmacy6030058.
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- Tsai J, Harpaz-Rotem I, Pilver CE, Wolf EJ, Hoff RA, Levy KN, Sareen J, Pietrzak RH. Latent class analysis of personality disorders in adults with posttraumatic stress disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2014 Mar;75(3):276-84. doi: 10.4088/JCP.13m08466.
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- Soder HE, Cooper JA, Lopez-Gamundi P, Hoots JK, Nunez C, Lawlor VM, Lane SD, Treadway MT, Wardle MC. Dose-response effects of d-amphetamine on effort-based decision-making and reinforcement learning. Neuropsychopharmacology. 2021 May;46(6):1078-1085. doi: 10.1038/s41386-020-0779-8. Epub 2020 Jul 28.
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- Shiner B, Forehand JA, Rozema L, Kulldorff M, Watts BV, Trefethen M, Jiang T, Huybrechts KF, Schnurr PP, Vincenti M, Gui J, Gradus JL. Mining Clinical Data for Novel Posttraumatic Stress Disorder Medications. Biol Psychiatry. 2022 Apr 1;91(7):647-657. doi: 10.1016/j.biopsych.2021.10.008. Epub 2021 Oct 20.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de setembro de 2026
Conclusão Primária (Estimado)
15 de setembro de 2027
Conclusão do estudo (Estimado)
15 de setembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
15 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de junho de 2026
Primeira postagem (Real)
24 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB25-1935
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Sim
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