Adderall, Post Traumatic Stress Disorder, PTSD
Conditions
Brief 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.
Detailed description
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.
Interventions
DRUGPlacebo
dextrose
DRUGAdderall
mixed amphetamine salts
Sponsors
University of Chicago
Cures Within Reach
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Social Interaction Ratings using the Conversation Questionnaire | 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 |
| Quality of Social Interaction Ratings using connection during conversation scale | 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 |
Countries
United States
Contacts
CONTACTHanna Molla
PRINCIPAL_INVESTIGATORRoyce Lee, MD
University of Chicago
Outcome results
None listed