Effects of Stimulant Medications in PTSD

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Chicago

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age 18 - 65 years old

BMI 19-30 kg/m2

English fluency

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Placebo

    Drug

    dextrose

  • Adderall

    Drug

    mixed amphetamine salts

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: placeboPlacebo comparator 1 intervention
Group B: AdderallExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quality of Social Interaction Ratings using the Conversation Questionnaire

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)
2

Quality of Social Interaction Ratings using connection during conversation scale

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

Time frame
Completed 4 hours post-drug administration during both sessions (drug, placebo)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Cures Within Reach

Collaborator

This trial is not recruiting at the moment. You can still explore other options: