Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1U01DA059791-01A1
PF614-MPAR: clinical development of opioid with oral overdose protection Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA ENSYSCE BIOSCIENCES, INC. KIRKPATRICK, LYNN La Jolla, CA 2024
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
NOFO Number: PAR-22-202
1R01DA061773-01
Neurotensin receptor 1 as a novel target for opioid use disorder and discovery of new small molecule probes Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA UNIVERSITY OF MINNESOTA SLOSKY, LAUREN M (contact); OLSON, STEVEN H Minneapolis, MN 2024
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-24-063
1UG3DA060053-01
Development of a Safer and More Effective Ibogaine Analog for the Treatment of Opioid Use Disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA GILGAMESH PHARMACEUTICALS, INC. MAREK, GERARD JOSEPH New York, NY 2024
NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-22-200
4UH3DA048767-03
Development of a Soluble Epoxide Hydrolase Inhibitor to Spare or Replace Opioid Analgesics Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA EICOSIS, LLC CORTES-PUCH, IRENE (contact); HAMMOCK, BRUCE D Davis, CA 2024
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trials Optional)
NOFO Number: RFA-DA-19-002
1UG3DA062088-01
Evaluation of psilocybin as an adjunctive treatment for opioid use disorder in methadone-maintained patients who continue to use illicit opioids Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE BOGENSCHUTZ, MICHAEL PARKS New York, NY 2024
NOFO Title: Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional)
NOFO Number: RFA-DA-25-058
1U01DA059994-01
Efficacy, safety, and pharmacokinetic study of BICX104 naltrexone subcutaneous implant alone and in combination with bupropion for the treatment of Methamphetamine Use Disorder (MUD). Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA BIOCORRX PHARMACEUTICALS, INC. DEVARNEY, KATE BEEBE Anaheim, CA 2024
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
NOFO Number: PAR-22-202
4UH3DA050323-02
Cannabidiol in the treatment of opioid use disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI HURD, YASMIN L New York, NY 2024
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trials Optional)
NOFO Number: RFA-DA-19-002
4UH3DA047793-03
tDCS to Decrease Opioid Relapse Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA BUTLER HOSPITAL ABRANTES, ANA M (contact); STEIN, MICHAEL D Providence, RI 2024
NOFO Title: Device-Based Treatments for Substance Use Disorders (UG3/UH3) (Clinical Trial Optional)
NOFO Number: PAR-18-494
1U01DA060704-01A1
Development of the novel mu-opioid receptor antagonist methocinnamox (MCAM) for preventing relapse and overdose Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER FRANCE, CHARLES P San Antonio, TX 2024
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
NOFO Number: PAR-22-202
1R21DA061784-01
Preclinical Trial: Targeting the Neuropeptide S Receptor to Curb Opioid Taking and Seeking Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA STATE UNIVERSITY OF NEW YORK AT BUFFALO CLARK, STEWART DONALDSON Amherst, NY 2024
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R21 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-24-064
1UG3DA059278-01A1
Development of SBS-226, a MOR agonist / DOR antagonist, for OUD Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA SPARIAN BIOSCIENCES, INC. REICH, JEFFREY New York, NY 2024
NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-22-200
4UH3DA048338-03
A Long-Acting Bioabsorbable Naltrexone Subcutaneous Implant for Opioid Use Disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA DRUG DELIVERY COMPANY, LLC COHEN, STEVEN M (contact); BENNER, JEFFREY Salisbury, MD 2024
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trials Optional)
NOFO Number: RFA-DA-19-002
1UG3DA062106-01
Targeting Treatment-Resistant OUD with Ketamine-Assisted Mindfulness-Oriented Recovery Enhancement Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA UNIVERSITY OF UTAH GARLAND, ERIC LEE (contact); NUNES, EDWARD V Salt Lake City, UT 2024
NOFO Title: Psychedelics Treatment Research in Substance Use Disorder (UG3/UH3 Clinical Trials Optional)
NOFO Number: RFA-DA-25-058
1U01DA060708-01
Phase III double-blind, randomized controlled trial of suvorexant versus placebo to treat insomnia in persons with opioid use disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA JOHNS HOPKINS UNIVERSITY HUHN, ANDREW S Baltimore, MD 2024
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
NOFO Number: PAR-22-202
1R01DA061771-01
Pharmacological targeting of nascent modulators of opioid signaling Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA UNIVERSITY OF FLORIDA MARTEMYANOV, KIRILL A Gainesville, FL 2024
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R01 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-24-063
4UH3DA054825-03
A novel and highly selective orexin 1 receptor antagonist for the treatment of patients with opioid use disorder. Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA ASTRAZENECA PHARMACEUTICALS, LP GURRELL, IAN Wilmington, DE 2024
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: PAR-20-092
1U01DA061643-01
Select Late-Stage CMC, Non-clinical Studies, and Quality Programs to Accelerate NRS-033 Towards Pivotal Studies and Registration in Opioid Use Disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA NIRSUM LABORATORIES, INC. SHAH, NIKEJ (contact); SORENSON, MARK New York, NY 2024
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional)
NOFO Number: PAR-22-202
1R21DA062022-01
Neuropeptide S Receptor 1 as a Novel Target for Reducing Opioid Self-Administration and Opioid Relapse Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER TUNSTALL, BRENDAN Memphis, TN 2024
NOFO Title: HEAL Initiative: Novel Targets for Opioid Use Disorders and Opioid Overdose (R21 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-24-064
1UG3DA061620-01
Registration Development Program for LUCEMYRA (Lofexidine) Label Expansion for Opioid Withdrawal Treatment in Adolescents Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA USWM, LLC MASSEY, VERONICA LYNCH (contact); SCHMIDT, LEE Louisville, KY 2024
NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-22-200
4UH3DA050325-03
Use of a GLP-1 Agonist to Treat Opioid Use Disorder in Rats and Man Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA PENN STATE HEALTH HERSHEY MEDICAL CENTER GRIGSON, PATRICIA SUE (contact); BRICK, TIMOTHY R; BUNCE, SCOTT C; NYLAND, JENNIFER E Hershey, PA 2024
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trials Optional)
NOFO Number: RFA-DA-19-002
1UG3DA058544-01A1
Antibody-based therapy for fentanyl-related opioid use disorder Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA MCLEAN HOSPITAL DESAI, RAJEEV INDRAJIT (contact); BREMER, PAUL T Belmont, MA 2023
NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-22-200
1UG3DA058552-01
Development of a Potent and Selective NaV1.8 Inhibitor for the Treatment of Acute and Chronic Pain with the Goal of Reducing Opioid Use and Preventing Opioid Use Disorders Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA SITEONE THERAPEUTICS, INC. HUNTER, JOHN CURETON (contact); MULCAHY, JOHN VINCENT South San Francisco, CA 2023
NOFO Title: Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose (UG3/UH3) (Clinical Trial Optional)
NOFO Number: PAR-20-092
Summary:

The sodium channel NaV1.8 is a promising target for the development of effective, non-addictive pain medications. Recent evidence from clinical studies indicates that medications that target NaV1.8 are effective at managing postoperative, neuropathic, and inflammatory pain, but with side effects and prohibitively high cost. This project will test the safety and compatibility in the body of an NaV1.8-targeted molecule, toward developing an effective, non-addictive, once daily oral medication for the treatment of acute postsurgical pain and chronic neuropathic. 
1UG3DA059285-01
Development of Cebranopadol, a Potent Dual MOP/NOP Agonist, for the Treatment of Opioid Use Disorder (OUD) Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA PARK THERAPEUTICS, INC. GRIECO, JOSEPH (contact); GREENWALD, MARK K; CICCOCIOPPO, ROBERTO Morristown, NJ 2023
NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-22-200
Summary:

There is an urgent need for improved medications to treat OUD. This project will test cebranopadol, a novel synthetic medication that interacts in a new way with the human opioid system as a safe and potentially effective alternative treatment for OUD. The research will test the safety and efficacy of cebranopadol in preclinical and clinical studies, toward guiding future research to support potential approval of this medication by the U.S. Food and Drug Administration.
U01DA058548-01
Clinical Development of a Therapeutic Agent for Rapid Reversal of Methamphetamine Intoxication Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA CLEAR SCIENTIFIC, LLC LI, XINHUA Cambridge, MA 2023
NOFO Title: Grand Opportunity in Medications Development for Substance-Use Disorders (U01 - Clinical Trial Optional)
NOFO Number: PAR-19-327
Summary:

Currently there are no safe, rapidly acting treatments for methamphetamine use disorder and overdose. This project will evaluate a potential treatment: the small molecule CS-1103, which selectively attaches to methamphetamine in the blood. This molecule quickly removes methamphetamine blood and into urine for elimination from the body. The research will evaluate the safety and compatibility of CS-1103 with the human body, toward future clinical testing in humans. 
1UG3DA059270-01
Long-Acting Biodegradable Buprenorphine Depots Novel Therapeutic Options for Opioid Use Disorder and Overdose Focusing Medication Development to Prevent and Treat Opioid Use Disorder and Overdose NIDA PURDUE UNIVERSITY OTTE, ANDREW West Lafayette, IN 2023
NOFO Title: Development of Medications to Prevent and Treat Opioid and/or Stimulant Use Disorders and Overdose (UG3/UH3 - Clinical Trial Optional)
NOFO Number: PAR-22-200
Summary:

Buprenorphine is an effective treatment for opioid use disorder, but its use is limited due to the need for frequent dosing. This project will optimize the molecular features of an injectable, biodegradable, long-acting (3-month) buprenorphine implant that would not require surgical removal. The research aims to advance toward testing in human research participants.