Effects of Stimulant Medications in PTSD

NCT07664631 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB25-1935
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Adderall; PTSD; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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

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

Study Arms (2)

placebo

PLACEBO COMPARATOR

dextrose

Drug: Placebo

Adderall

EXPERIMENTAL

Adderall (20 mg)

Drug: Adderall

Interventions

Placebo DRUG

dextrose

placebo

Adderall DRUG

mixed amphetamine salts

Adderall

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Cures Within Reach: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Adderall

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Royce Lee, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Molla

CONTACT

7737023560; hmolla@uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

US (1)