Effects of Stimulant Medications in PTSD

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Placebo
  dextrose
• Препарат Adderall
  mixed amphetamine salts

Первичные конечные точки

• Quality of Social Interaction Ratings using the Conversation Questionnaire [Срок оценки: Completed 4 hours post-drug administration during both sessions (drug, placebo)]
• Quality of Social Interaction Ratings using connection during conversation scale [Срок оценки: Completed 4 hours post-drug administration during both sessions (drug, placebo)]

Критерии участия

Критерии включения

• Age 18 - 65 years old
• BMI 19-30 kg/m2
• English fluency

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Chicago — Chicago

Публикации

• 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. PMID 36158332
• 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. PMID 19141307
• 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. PMID 27562198
• 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. PMID 26606250
• 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. PMID 34236411
• 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. PMID 26164054
• 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. PMID 29954141
• 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 PMID 36335070

Идентификаторы

NCT: NCT07664631 · IRB25-1935

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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