Effects of Stimulant Medications in PTSD (SMP)
18 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hanna Molla
- Número de teléfono: 7737023560
- Correo electrónico: hmolla@uchicago.edu
Ubicaciones de estudio
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60637
- University of Chicago
-
Contacto:
- Hanna Molla
- Número de teléfono: 7737023560
- Correo electrónico: hmolla@uchicago.edu
-
Investigador principal:
- Royce Lee
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Social Interaction Ratings using the Conversation Questionnaire
Periodo de tiempo: 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
|
Completed 4 hours post-drug administration during both sessions (drug, placebo)
|
|
Quality of Social Interaction Ratings using connection during conversation scale
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Royce Lee, MD, University of Chicago
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
- Markowitz JC, Petkova E, Neria Y, Van Meter PE, Zhao Y, Hembree E, Lovell K, Biyanova T, Marshall RD. Is Exposure Necessary? A Randomized Clinical Trial of Interpersonal Psychotherapy for PTSD. Am J Psychiatry. 2015 May;172(5):430-40. doi: 10.1176/appi.ajp.2014.14070908. Epub 2015 Feb 13.
- Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
- Brewin CR, Andrews B, Valentine JD. Meta-analysis of risk factors for posttraumatic stress disorder in trauma-exposed adults. J Consult Clin Psychol. 2000 Oct;68(5):748-66. doi: 10.1037//0022-006x.68.5.748.
- Martin WR, Sloan JW, Sapira JD, Jasinski DR. Physiologic, subjective, and behavioral effects of amphetamine, methamphetamine, ephedrine, phenmetrazine, and methylphenidate in man. Clin Pharmacol Ther. 1971 Mar-Apr;12(2):245-58. doi: 10.1002/cpt1971122part1245. No abstract available.
- Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
- Krystal JH, Davis LL, Neylan TC, A Raskind M, Schnurr PP, Stein MB, Vessicchio J, Shiner B, Gleason TC, Huang GD. It Is Time to Address the Crisis in the Pharmacotherapy of Posttraumatic Stress Disorder: A Consensus Statement of the PTSD Psychopharmacology Working Group. Biol Psychiatry. 2017 Oct 1;82(7):e51-e59. doi: 10.1016/j.biopsych.2017.03.007. Epub 2017 Mar 14. No abstract available.
- Gibbons RD, Kupfer DJ, Frank E, Lahey BB, George-Milford BA, Biernesser CL, Porta G, Moore TL, Kim JB, Brent DA. Computerized Adaptive Tests for Rapid and Accurate Assessment of Psychopathology Dimensions in Youth. J Am Acad Child Adolesc Psychiatry. 2020 Nov;59(11):1264-1273. doi: 10.1016/j.jaac.2019.08.009. Epub 2019 Aug 26.
- Barreto C, Vila Irigoyen A, Lopez O, Gralnik L. Psychostimulants for the Treatment of Comorbid Post-traumatic Stress Disorder (PTSD) in a Patient With Attention-Deficit/Hyperactivity Disorder (ADHD): A Case Report and Literature Summary. Cureus. 2022 Aug 20;14(8):e28199. doi: 10.7759/cureus.28199. eCollection 2022 Aug.
- Berger W, Mendlowicz MV, Marques-Portella C, Kinrys G, Fontenelle LF, Marmar CR, Figueira I. Pharmacologic alternatives to antidepressants in posttraumatic stress disorder: a systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Mar 17;33(2):169-80. doi: 10.1016/j.pnpbp.2008.12.004. Epub 2008 Dec 24.
- Bershad AK, Miller MA, Baggott MJ, de Wit H. The effects of MDMA on socio-emotional processing: Does MDMA differ from other stimulants? J Psychopharmacol. 2016 Dec;30(12):1248-1258. doi: 10.1177/0269881116663120. Epub 2016 Aug 25.
- Brenner LA, Betthauser LM, Penzenik M, Germain A, Li JJ, Chattopadhyay I, Frank E, Kupfer DJ, Gibbons RD. Development and Validation of Computerized Adaptive Assessment Tools for the Measurement of Posttraumatic Stress Disorder Among US Military Veterans. JAMA Netw Open. 2021 Jul 1;4(7):e2115707. doi: 10.1001/jamanetworkopen.2021.15707.
- Guina J, Rossetter SR, DeRHODES BJ, Nahhas RW, Welton RS. Benzodiazepines for PTSD: A Systematic Review and Meta-Analysis. J Psychiatr Pract. 2015 Jul;21(4):281-303. doi: 10.1097/PRA.0000000000000091.
- 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.
- Wendt FR, Garcia-Argibay M, Cabrera-Mendoza B, Valdimarsdottir UA, Gelernter J, Stein MB, Nivard MG, Maihofer AX; Post-Traumatic Stress Disorder Working Group of the Psychiatric Genomics Consortium; Nievergelt CM, Larsson H, Mattheisen M, Polimanti R, Meier SM. The Relationship of Attention-Deficit/Hyperactivity Disorder With Posttraumatic Stress Disorder: A Two-Sample Mendelian Randomization and Population-Based Sibling Comparison Study. Biol Psychiatry. 2023 Feb 15;93(4):362-369. doi: 10.1016/j.biopsych.2022.08.012. Epub 2022 Aug 24.
- Weafer J, Van Hedger K, Keedy SK, Nwaokolo N, de Wit H. Methamphetamine acutely alters frontostriatal resting state functional connectivity in healthy young adults. Addict Biol. 2020 May;25(3):e12775. doi: 10.1111/adb.12775. Epub 2019 May 16.
- 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.
- Stein DJ, Ipser JC, Seedat S. Pharmacotherapy for post traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD002795. doi: 10.1002/14651858.CD002795.pub2.
- 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.
- Shiner B, Westgate CL, Gui J, Maguen S, Young-Xu Y, Schnurr PP, Watts BV. A Retrospective Comparative Effectiveness Study of Medications for Posttraumatic Stress Disorder in Routine Practice. J Clin Psychiatry. 2018 Sep 18;79(5):18m12145. doi: 10.4088/JCP.18m12145.
- 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.
- Seidemann R, Duek O, Jia R, Levy I, Harpaz-Rotem I. The Reward System and Post-Traumatic Stress Disorder: Does Trauma Affect the Way We Interact With Positive Stimuli? Chronic Stress (Thousand Oaks). 2021 Feb 25;5:2470547021996006. doi: 10.1177/2470547021996006. eCollection 2021 Jan-Dec.
- Schultz W. Dopamine reward prediction-error signalling: a two-component response. Nat Rev Neurosci. 2016 Mar;17(3):183-95. doi: 10.1038/nrn.2015.26. Epub 2016 Feb 11.
- Reece A, Cooney G, Bull P, Chung C, Dawson B, Fitzpatrick C, Glazer T, Knox D, Liebscher A, Marin S. The CANDOR corpus: Insights from a large multimodal dataset of naturalistic conversation. Sci Adv. 2023 Mar 31;9(13):eadf3197. doi: 10.1126/sciadv.adf3197. Epub 2023 Mar 31.
- Platt J, Keyes KM, Koenen KC. Size of the social network versus quality of social support: which is more protective against PTSD? Soc Psychiatry Psychiatr Epidemiol. 2014 Aug;49(8):1279-86. doi: 10.1007/s00127-013-0798-4. Epub 2013 Dec 6.
- Okabe-Miyamoto K, Folk D, Lyubomirsky S, Dunn EW. Changes in social connection during COVID-19 social distancing: It's not (household) size that matters, it's who you're with. PLoS One. 2021 Jan 20;16(1):e0245009. doi: 10.1371/journal.pone.0245009. eCollection 2021.
- Markowitz JC, Petkova E, Biyanova T, Ding K, Suh EJ, Neria Y. EXPLORING PERSONALITY DIAGNOSIS STABILITY FOLLOWING ACUTE PSYCHOTHERAPY FOR CHRONIC POSTTRAUMATIC STRESS DISORDER. Depress Anxiety. 2015 Dec;32(12):919-26. doi: 10.1002/da.22436. Epub 2015 Oct 6.
- Malikowska-Racia N, Salat K, Nowaczyk A, Fijalkowski L, Popik P. Dopamine D2/D3 receptor agonists attenuate PTSD-like symptoms in mice exposed to single prolonged stress. Neuropharmacology. 2019 Sep 1;155:1-9. doi: 10.1016/j.neuropharm.2019.05.012. Epub 2019 May 11.
- Lee R. Mistrustful and Misunderstood: A Review of Paranoid Personality Disorder. Curr Behav Neurosci Rep. 2017 Jun;4(2):151-165. doi: 10.1007/s40473-017-0116-7. Epub 2017 May 18.
- Kirschner H, Molla HM, Nassar MR, de Wit H, Ullsperger M. Methamphetamine-induced adaptation of learning rate dynamics depend on baseline performance. Elife. 2025 Jul 21;13:RP101413. doi: 10.7554/eLife.101413.
- Kern DM, Teneralli RE, Flores CM, Wittenberg GM, Gilbert JP, Cepeda MS. Revealing Unknown Benefits of Existing Medications to Aid the Discovery of New Treatments for Post-Traumatic Stress Disorder. Psychiatr Res Clin Pract. 2021 Dec 20;4(1):12-20. doi: 10.1176/appi.prcp.20210019. eCollection 2022 Spring.
- Howlett JR, Stein MB. Post-Traumatic Stress Disorder: Relationship to Traumatic Brain Injury and Approach to Treatment. In: Laskowitz D, Grant G, editors. Translational Research in Traumatic Brain Injury. Boca Raton (FL): CRC Press/Taylor and Francis Group; 2016. Chapter 16. Available from http://www.ncbi.nlm.nih.gov/books/NBK326723/
- Howlett JR, Campbell-Sills L, Jain S, Heeringa SG, Nock MK, Sun X, Ursano RJ, Stein MB. Attention Deficit Hyperactivity Disorder and Risk of Posttraumatic Stress and Related Disorders: A Prospective Longitudinal Evaluation in U.S. Army Soldiers. J Trauma Stress. 2018 Dec;31(6):909-918. doi: 10.1002/jts.22347. Epub 2018 Nov 21.
- Houlihan DJ. Psychostimulant treatment of combat-related posttraumatic stress disorder. J Psychopharmacol. 2011 Nov;25(11):1568-72. doi: 10.1177/0269881110385600. Epub 2010 Oct 8.
- Holder N, Woods A, Neylan TC, Maguen S, Seal KH, Bernardy N, Wiechers I, Ryder A, Urbieta AM, Cohen BE. Trends in Medication Prescribing in Patients With PTSD From 2009 to 2018: A National Veterans Administration Study. J Clin Psychiatry. 2021 May 4;82(3):20m13522. doi: 10.4088/JCP.20m13522.
- Gros DF, Flanagan JC, Korte KJ, Mills AC, Brady KT, Back SE. Relations among social support, PTSD symptoms, and substance use in veterans. Psychol Addict Behav. 2016 Nov;30(7):764-770. doi: 10.1037/adb0000205. Epub 2016 Oct 27.
- de Wit H, Enggasser JL, Richards JB. Acute administration of d-amphetamine decreases impulsivity in healthy volunteers. Neuropsychopharmacology. 2002 Nov;27(5):813-25. doi: 10.1016/S0893-133X(02)00343-3.
- Daly OE. The use of stimulants in the treatment of post traumatic stress disorder: case report. Hum Psychopharmacol. 2000 Jun;15(4):295-300. doi: 10.1002/1099-1077(200006)15:43.0.CO;2-O.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de septiembre de 2026
Finalización primaria (Estimado)
15 de septiembre de 2027
Finalización del estudio (Estimado)
15 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de junio de 2026
Publicado por primera vez (Actual)
24 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB25-1935
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .