University of Chicago
Chicago, Illinois, 60637, United States
NCT Number: NCT07664631
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 1
Chicago, Illinois, 60637, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
dextrose
mixed amphetamine salts
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
University of Chicago
Other
Acronym: SMP
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