49 completed, 7 terminated, 5 unknown, 4 withdrawn. 70 Phase 2, 9 Phase 1, 6 Phase 3.
Follow Modafinil: new trials by email Literature Review of Modafinil trials Research Report on Modafinil
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Psilocybin for Depression in Veterans Psilocybin, modafinil, zolpidem - Major Depression | Phase 2 | Not yet recruiting | VA Office of Research and Development | 150 | 2027-01-01 | 2026-10-26 |
| Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease MODIFI-IBD Trial) Modafinil, Placebo - Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Chronic Fatigue | Phase 2 / Phase 3 | Recruiting | Radboud University Medical Center | 60 | 2026-08-03 | 2026-09-14 |
| Modafinil to Improve Fatiguability Modafinil, Placebo - Cancer-related Cognitive Difficulties, Cancer-related Problem/Condition | Phase 1 / Phase 2 | Recruiting | Ottawa Hospital Research Institute | 40 | 2026-03-16 | 2026-07-27 |
| Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial Modafinil, Placebo - Crohn Disease (CD), Ulcerative Colitis (UC) | Phase 2 | Not yet recruiting | Imperial College London | 70 | 2026-02-01 | 2025-12-22 |
| RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) Modafinil, Modafinil Placebo, Solriamfetol - Long COVID, Long COVID-19 | Phase 2 | Completed | Duke University | 361 | 2024-08-12 | 2026-06-03 |
| RECOVER-SLEEP: Platform Protocol Modafinil, Modafinil Placebo, Solriamfetol - Long COVID, Long COVID-19 | Phase 2 | Completed | Duke University | 830 | 2024-07-31 | 2026-01-22 |
| Psilocybin Therapy for Chronic Low Back Pain Psilocybin therapy with Zolpidem and Modafinil, Psilocybin therapy with Zolpidem, Psilocybin therapy with Modafinil - Chronic Low-back Pain | Phase 1 / Phase 2 | Completed | Joshua Woolley, MD, PhD | 40 | 2023-12-01 | 2026-11-04 |
| Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants Modafinil 200mg, mixed amphetamine salts, Placebo - Cognition | Phase 2 | Unknown | United States Army Aeromedical Research Laboratory | 80 | 2019-07-17 | 2019-07-31 |
| Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia Modafinil, Amphetamine-Dextroamphetamine - Idiopathic Hypersomnia, Narcolepsy Without Cataplexy | Phase 2 | Completed | Emory University | 44 | 2019-04-15 | 2024-05-23 |
| Modafinil for the Treatment of Alcohol Use Disorders Modafinil, Placebo - Alcohol Use Disorder | Phase 2 | Completed | The Mind Research Network | 12 | 2017-12-11 | 2020-05-26 |
| Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD) modafinil 50mg, Placebo oral capsule - Parkinson Disease | Phase 2 | Completed | University of Arkansas | 21 | 2017-06-13 | 2021-10-27 |
| Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention Acceptance and Commitment Therapy (ACT), Drug Counseling (DC), Contingency Management (CM) - Cocaine-Related Disorders | Phase 2 | Completed | The University of Texas Health Science Center, Houston | 118 | 2016-11-18 | 2023-02-08 |
| A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients Duloxetine, Donepezil, Modafinil - Parkinson's Disease | Phase 2 | Withdrawn | University of Chicago | 2016-11-01 | 2017-12-12 | |
| Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Active comparator: Modafinil + placebo, THN102 300/3, THN102 300/27 - Narcolepsy | Phase 2 | Completed | Theranexus | 51 | 2016-09-01 | 2020-09-04 |
| Improving Therapeutic Learning in Depression: Proof of Concept 250 mg DCS, 100 mg Modafinil, Placebo - Major Depressive Disorder | Phase 2 | Completed | Boston University Charles River Campus | 36 | 2014-09-16 | 2018-09-19 |
| Symptom Burden in Head and Neck Cancer Placebo, Armodafinil, Minocycline - Head And Neck Cancer | Phase 1 / Phase 2 | Terminated | M.D. Anderson Cancer Center | 1 | 2013-03-01 | 2015-02-10 |
| A Phase II Study of Minocycline and Armodafinil for Reducing the Symptom Burden Produced by Chemoradiation Treatment for Esophageal Cancer Armodafinil, Placebo, Minocycline - Esophageal Cancer | Phase 2 | Completed | M.D. Anderson Cancer Center | 22 | 2013-02-01 | 2018-06-06 |
| Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder) Modafinil - Posttraumatic Stress Disorder | Phase 2 / Phase 3 | Unknown | Biomedical Research Foundation | 40 | 2012-08-01 | 2012-11-14 |
| A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence Modafinil - Methamphetamine Dependence | Phase 2 | Completed | California Pacific Medical Center Research Institute | 72 | 2011-10-01 | 2013-07-02 |
| Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor modafinil, placebo - Brain and Central Nervous System Tumors, Cognitive/Functional Effects | Phase 2 | Completed | University of South Florida | 112 | 2011-08-01 | 2021-08-13 |
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Cocaine-Related Disorders (15) · Fatigue (15) · Schizophrenia (4) · Disorders of Excessive Somnolence (3) · Glioma (3) · Neoplasms (3) · cyclopia sequence (3) · Alcoholism (2) · Amphetamine-Related Disorders (2) · Central Nervous System Neoplasms (2) · Colitis, Ulcerative (2) · Depression (2) · Depressive Disorder, Major (2) · Head and Neck Neoplasms (2) · Narcolepsy (2)
Cephalon (5) · Duke University (4) · M.D. Anderson Cancer Center (4) · The University of Texas Health Science Center, Houston (4) · University of Arkansas (4) · California Pacific Medical Center Research Institute (3) · Kyle Kampman (2) · Medical University of South Carolina (2) · National Institute on Drug Abuse (NIDA) (2) · The University of New South Wales (2) · University of Rochester (2) · University of South Florida (2) · Yale University (2) · Abramson Cancer Center at Penn Medicine (1) · Alza Corporation, DE, USA (1)
United States (56) · Australia (2) · Canada (2) · Belgium (1) · Bulgaria (1) · France (1) · Germany (1) · Hungary (1) · Netherlands (1) · Romania (1) · United Kingdom (1)
Christina Barkauskas, MD (2) · Gantt Galloway, PharmD (2) · Joy M Schmitz, PhD (2) · Richard P Mattick, PhD (2) · Susan Redline, MD MPH (2) · Ahmed Elkashef, M.D. (1) · Andrew Krystal, MD (1) · Calum Moulton (1) · Charles Dackis (1) · Claire Wilcox, MD (1) · David I. Rosenthal, MD, MA, BA (1) · Domenic Ciraulo, M.D. (1) · Dr. Janette McGaugh, MD (1)
PMID 41170811, PMID 20565514, PMID 15911704, PMID 19149817, PMID 19687359, PMID 20092966, PMID 20673554, PMID 20816042, PMID 21035624, PMID 21840138, PMID 22178084, PMID 22217949, PMID 22445683, PMID 22969732, PMID 24002370, PMID 24227635, PMID 24315572, PMID 24424425, PMID 24495468, PMID 24606242, PMID 24721800, PMID 25452447, PMID 30621831, PMID 31233323, PMID 32673517, PMID 33630644, PMID 34559026, PMID 36480395, PMID 36999619, PMID 39207396, PMID 39306601, PMID 41451557
P50DA009262 (3), U10CA081920 (2), 2015 (1), K07CA132916 (1), K23DA016743 (1), P20GM103425 (1), P20RR020146 (1), P50DA012756 (1), P50DA018185 (1), P50DA018197 (1), R01CA026582 (1), R01CA126968 (1), R01DA015366 (1), R01DA016368 (1), R01DA021264 (1)