AdderallPhase 1SMPNCT07664631
Effects of Stimulant Medications in PTSD
A Phase 1 study testing Adderall in people with Adderall and PTSD, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adderall, PTSD, Post Traumatic Stress Disorder
- What is being tested?
- Adderall
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 15 Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years old
- BMI 19-30 kg/m2
- English fluency
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Chicago
Chicago, Illinois, 60637
Hanna Molla, 7737023560, hmolla@uchicago.edu
Royce Lee
About this study
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.
Read the 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.
- Conditions
- Adderall, PTSD, Post Traumatic Stress Disorder
- Being tested
- Placebo, Adderall
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
dextrose
AdderallDrug
mixed amphetamine salts
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | dextrose Receives: Drug: Placebo |
| Adderall | Experimental | Adderall (20 mg) Receives: Drug: Adderall |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Completed 4 hours post-drug administration during both sessions (drug, placebo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for AdderallStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Cures Within Reach
- Responsible party
- Sponsor
- Investigators
- Royce Lee, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664631
- Sponsor's protocol ID
- IRB25-1935
- Acronym
- SMP
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barreto C, Vila Irigoyen A, Lopez O, Gralnik L. Psychostimulants for the Treatment of Comorbid Post-traumatic Stress Disorder (PTSD) in a Patient With Attention-Deficit/Hyperactivity Disorder (ADHD): A Case Report and Literature Summary. Cureus. 2022 Aug 20;14(8):e28199. doi: 10.7759/cureus.28199. eCollection 2022 Aug.
PubMed 36158332Berger W, Mendlowicz MV, Marques-Portella C, Kinrys G, Fontenelle LF, Marmar CR, Figueira I. Pharmacologic alternatives to antidepressants in posttraumatic stress disorder: a systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Mar 17;33(2):169-80. doi: 10.1016/j.pnpbp.2008.12.004. Epub 2008 Dec 24.
PubMed 19141307Bershad AK, Miller MA, Baggott MJ, de Wit H. The effects of MDMA on socio-emotional processing: Does MDMA differ from other stimulants? J Psychopharmacol. 2016 Dec;30(12):1248-1258. doi: 10.1177/0269881116663120. Epub 2016 Aug 25.
PubMed 27562198Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
PubMed 26606250Brenner LA, Betthauser LM, Penzenik M, Germain A, Li JJ, Chattopadhyay I, Frank E, Kupfer DJ, Gibbons RD. Development and Validation of Computerized Adaptive Assessment Tools for the Measurement of Posttraumatic Stress Disorder Among US Military Veterans. JAMA Netw Open. 2021 Jul 1;4(7):e2115707. doi: 10.1001/jamanetworkopen.2021.15707.
PubMed 34236411Guina J, Rossetter SR, DeRHODES BJ, Nahhas RW, Welton RS. Benzodiazepines for PTSD: A Systematic Review and Meta-Analysis. J Psychiatr Pract. 2015 Jul;21(4):281-303. doi: 10.1097/PRA.0000000000000091.
PubMed 26164054Weyandt LL, White TL, Gudmundsdottir BG, Nitenson AZ, Rathkey ES, De Leon KA, Bjorn SA. Neurocognitive, Autonomic, and Mood Effects of Adderall: A Pilot Study of Healthy College Students. Pharmacy (Basel). 2018 Jun 27;6(3):58. doi: 10.3390/pharmacy6030058.
PubMed 29954141Wendt FR, Garcia-Argibay M, Cabrera-Mendoza B, Valdimarsdottir UA, Gelernter J, Stein MB, Nivard MG, Maihofer AX; Post-Traumatic Stress Disorder Working Group of the Psychiatric Genomics Consortium; Nievergelt CM, Larsson H, Mattheisen M, Polimanti R, Meier SM. The Relationship of Attention-Deficit/Hyperactivity Disorder With Posttraumatic Stress Disorder: A Two-Sample Mendelian Randomization and Population-Based Sibling Comparison Study. Biol Psychiatry. 2023 Feb 15;93(4):362-369. doi: 10.1016/j.biopsych.2022.08.012. Epub 2022 Aug 24.
PubMed 36335070Weafer J, Van Hedger K, Keedy SK, Nwaokolo N, de Wit H. Methamphetamine acutely alters frontostriatal resting state functional connectivity in healthy young adults. Addict Biol. 2020 May;25(3):e12775. doi: 10.1111/adb.12775. Epub 2019 May 16.
PubMed 31099141Tsai J, Harpaz-Rotem I, Pilver CE, Wolf EJ, Hoff RA, Levy KN, Sareen J, Pietrzak RH. Latent class analysis of personality disorders in adults with posttraumatic stress disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2014 Mar;75(3):276-84. doi: 10.4088/JCP.13m08466.
PubMed 24345427Stein DJ, Ipser JC, Seedat S. Pharmacotherapy for post traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD002795. doi: 10.1002/14651858.CD002795.pub2.
PubMed 16437445Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
PubMed 26241600Soder HE, Cooper JA, Lopez-Gamundi P, Hoots JK, Nunez C, Lawlor VM, Lane SD, Treadway MT, Wardle MC. Dose-response effects of d-amphetamine on effort-based decision-making and reinforcement learning. Neuropsychopharmacology. 2021 May;46(6):1078-1085. doi: 10.1038/s41386-020-0779-8. Epub 2020 Jul 28.
PubMed 32722661Shiner B, Westgate CL, Gui J, Maguen S, Young-Xu Y, Schnurr PP, Watts BV. A Retrospective Comparative Effectiveness Study of Medications for Posttraumatic Stress Disorder in Routine Practice. J Clin Psychiatry. 2018 Sep 18;79(5):18m12145. doi: 10.4088/JCP.18m12145.
PubMed 30257081Shiner B, Forehand JA, Rozema L, Kulldorff M, Watts BV, Trefethen M, Jiang T, Huybrechts KF, Schnurr PP, Vincenti M, Gui J, Gradus JL. Mining Clinical Data for Novel Posttraumatic Stress Disorder Medications. Biol Psychiatry. 2022 Apr 1;91(7):647-657. doi: 10.1016/j.biopsych.2021.10.008. Epub 2021 Oct 20.
PubMed 34952698
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stimulant Medications in PTSD
- ClinicalTrials.gov ID
- NCT07664631
- Acronym / sponsor ID
- SMP / IRB25-1935
- Conditions
- Adderall, PTSD, Post Traumatic Stress Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Cures Within Reach
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebodextrose |
| Adderall | Experimental | Drug: AdderallAdderall (20 mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 65 years old
- BMI 19-30 kg/m2
- English fluency
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebodextrose | Drug | placebo |
| Adderallmixed amphetamine salts | Drug | Adderall |
Primary outcome
Quality of Social Interaction Ratings using the Conversation Questionnaire
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
Quality of Social Interaction Ratings using connection during conversation scale
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 36158332Barreto C, Vila Irigoyen A, Lopez O, Gralnik L. Psychostimulants for the Treatment of Comorbid Post-traumatic Stress Disorder (PTSD) in a Patient With Attention-Deficit/Hyperactivity Disorder (ADHD): A Case Report and Literature Summary. Cureus. 2022 Aug 20;14(8):e28199. doi: 10.7759/cureus.28199. eCollection 2022 Aug.
- Background: PubMed 19141307Berger W, Mendlowicz MV, Marques-Portella C, Kinrys G, Fontenelle LF, Marmar CR, Figueira I. Pharmacologic alternatives to antidepressants in posttraumatic stress disorder: a systematic review. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Mar 17;33(2):169-80. doi: 10.1016/j.pnpbp.2008.12.004. Epub 2008 Dec 24.
- Background: PubMed 27562198Bershad AK, Miller MA, Baggott MJ, de Wit H. The effects of MDMA on socio-emotional processing: Does MDMA differ from other stimulants? J Psychopharmacol. 2016 Dec;30(12):1248-1258. doi: 10.1177/0269881116663120. Epub 2016 Aug 25.
- Background: PubMed 26606250Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
- Background: PubMed 34236411Brenner LA, Betthauser LM, Penzenik M, Germain A, Li JJ, Chattopadhyay I, Frank E, Kupfer DJ, Gibbons RD. Development and Validation of Computerized Adaptive Assessment Tools for the Measurement of Posttraumatic Stress Disorder Among US Military Veterans. JAMA Netw Open. 2021 Jul 1;4(7):e2115707. doi: 10.1001/jamanetworkopen.2021.15707.
- Background: PubMed 26164054Guina J, Rossetter SR, DeRHODES BJ, Nahhas RW, Welton RS. Benzodiazepines for PTSD: A Systematic Review and Meta-Analysis. J Psychiatr Pract. 2015 Jul;21(4):281-303. doi: 10.1097/PRA.0000000000000091.
- Background: PubMed 29954141Weyandt LL, White TL, Gudmundsdottir BG, Nitenson AZ, Rathkey ES, De Leon KA, Bjorn SA. Neurocognitive, Autonomic, and Mood Effects of Adderall: A Pilot Study of Healthy College Students. Pharmacy (Basel). 2018 Jun 27;6(3):58. doi: 10.3390/pharmacy6030058.
- Background: PubMed 36335070Wendt FR, Garcia-Argibay M, Cabrera-Mendoza B, Valdimarsdottir UA, Gelernter J, Stein MB, Nivard MG, Maihofer AX; Post-Traumatic Stress Disorder Working Group of the Psychiatric Genomics Consortium; Nievergelt CM, Larsson H, Mattheisen M, Polimanti R, Meier SM. The Relationship of Attention-Deficit/Hyperactivity Disorder With Posttraumatic Stress Disorder: A Two-Sample Mendelian Randomization and Population-Based Sibling Comparison Study. Biol Psychiatry. 2023 Feb 15;93(4):362-369. doi: 10.1016/j.biopsych.2022.08.012. Epub 2022 Aug 24.
- Background: PubMed 31099141Weafer J, Van Hedger K, Keedy SK, Nwaokolo N, de Wit H. Methamphetamine acutely alters frontostriatal resting state functional connectivity in healthy young adults. Addict Biol. 2020 May;25(3):e12775. doi: 10.1111/adb.12775. Epub 2019 May 16.
- Background: PubMed 24345427Tsai J, Harpaz-Rotem I, Pilver CE, Wolf EJ, Hoff RA, Levy KN, Sareen J, Pietrzak RH. Latent class analysis of personality disorders in adults with posttraumatic stress disorder: results from the National Epidemiologic Survey on Alcohol and Related Conditions. J Clin Psychiatry. 2014 Mar;75(3):276-84. doi: 10.4088/JCP.13m08466.
- Background: PubMed 16437445Stein DJ, Ipser JC, Seedat S. Pharmacotherapy for post traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD002795. doi: 10.1002/14651858.CD002795.pub2.
- Background: PubMed 26241600Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Royce Lee, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adderall in people with Adderall and PTSD, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hanna Molla (7737023560, hmolla@uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Social Interaction Ratings using the Conversation Questionnaire (time frame: Completed 4 hours post-drug administration during both sessions (drug, placebo)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07664631, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.