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Not Yet Recruiting
NCT07664631
Effects of Stimulant Medications in PTSD
Conditions: Adderall, PTSD, Post Traumatic Stress Disorder
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 40
Sponsor: University of Chicago
Location: University of Chicago Chicago Illinois
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07664631). StuddyBuddy aggregates publicly available trial information.