Drugs / Methadone
last change 10 days ago re-read 8 days ago

Methadone

Other / unclassified

Developed for
neuropathy, painful · HIV infectious disease · substance-related disorder · opiate dependence · chronic pain syndrome · cancer · heroin dependence · cocaine abuse
+20 more · scoliosis · idiopathic scoliosis · chemotherapy-induced neuropathy · diabetic polyneuropathy · drug-induced mental disorder · leiomyoma · neonatal abstinence syndrome · neurological pain disorder · osteoarthritis, knee · peripheral neuropathy · polyneuropathy · postherpetic neuralgia · spinal cord injury · substance dependence · substance withdrawal syndrome · upper thoracic spina bifida aperta · adolescent idiopathic scoliosis · juvenile idiopathic scoliosis · neoplasm · sickle cell disease
Investigated by
National Institute on Drug Abuse (NIDA) · National Institute of Allergy and Infectious Diseases (NIAID) · University of Aarhus · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Merck Sharp & Dohme LLC · Washington University School of Medicine
+126 more · Yale University · Endeavor Health · GlaxoSmithKline · Indiana University · Johns Hopkins University · Mayo Clinic · University of Pennsylvania · University of Virginia · AHS Cancer Control Alberta · Canadian Institutes of Health Research (CIHR) · Chinese University of Hong Kong · Friends Research Institute, Inc. · Montefiore Medical Center · National Institute of Drug Abuse · Oregon Health and Science University · Pouya Azar · Senthil Sadhasivam · The University of Texas Health Science Center, Houston · University of Colorado, Denver · University of Louisville · University of Sao Paulo · University of Sao Paulo General Hospital · University of Southern Denmark · ViiV Healthcare · AESCA Pharma GmbH · AFP Innovation Fund · Aarhus University Hospital · AdventHealth · Alameda Health System · Alberta Health services · Alexandre P. Joosten · Astellas Pharma Global Development, Inc. · Atea Pharmaceuticals, Inc. · Basilea Pharmaceutica International Ltd · Baylor College of Medicine · Boehringer Ingelheim · Boston Medical Center (BMC) · Brandon Knopp · Bristol-Myers Squibb · British Columbia Cancer Agency · Brugmann University Hospital · Bruyère Health Research Institute. · Calgary Health Region · Case Western Reserve University · Cedars-Sinai Medical Center · Children's Mercy Hospital Kansas City · Columbia University · Dalhousie University · Didier Jutras Aswad · Expertise France · Faculdade de Medicina do ABC · Florida Department of Health · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · French National Agency for Research on AIDS and Viral Hepatitis · Glaxo Wellcome · Hennepin Healthcare Research Institute · Henry Ford Health System · Ho Chi Minh City CDC · Hoffmann-La Roche · Indivior Inc. · Institute of Applied Medicine and Epidemiology (IMEA) · John van den Anker · Johns Hopkins All Children's Hospital · Kaiser Permanente · Kanecia Obie Zimmerman · Kantonsspital Baden · Karolinska University Hospital · Keck School of Medicine of USC · Kuopio University Hospital · Lahey Clinic · Laura and John Arnold Foundation · M.D. Anderson Cancer Center · Maastricht University Medical Center · Mahidol University · all 132 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) METHADONE HYDROCHLORIDE — 1947-08-13 fda.gov ↗

Trials 132 · started per year

today
US approved 1947
1
1
1
2
2
2
1
1
2
3
4
2
2
1
11
5
8
5
7
5
3
5
5
1
6
2
2
2
8
10
13
8
1
19461947194819491950195119521953195419551956195719581959196019611962196319641965196619671968196919701971197219731974197519761977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028202920302031
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials
Phase 0 NCT06810336 Mar 2025 → Sep 2027 expected brain injury, brain neoplasm University of Virginia Recruiting No outcome recorded
Phase 0 NCT06387303 Aug 2024 → May 2026 overdue — University of Virginia Recruiting No outcome recorded
Phase 0 NCT05789173 Oct 2023 → Aug 2026 overdue — Indiana University Recruiting No outcome recorded
Phase 0 NCT04027166 Jul 2019 → Mar 2021 — Yale University Completed No outcome recorded
Phase 0 NCT03525509 Jun 2018 → Aug 2019 — simon.haroutounian Completed No outcome recorded
Phase 125 trials
Phase 1 NCT07595263 Aug 2026 → Jan 2027 expected — Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1 NCT07528508 May → Aug 2026 overdue — Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 1 NCT06877858 Sep 2025 → Mar 2027 expected substance-related disorder University of Pennsylvania Recruiting No outcome recorded
Phase 1 NCT07314346 Jan 2025 → Aug 2026 overdue — Atea Pharmaceuticals, Inc. Recruiting No outcome recorded
Phase 1 NCT02666001 Jan → Jun 2016 HIV infectious disease ViiV Healthcare Completed No outcome recorded
Phase 1 NCT02715700 Sep 2015 → Jun 2016 HIV infectious disease Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT02531906 Apr 2015 → Jun 2018 head and neck squamous cell carcinoma, stomatitis Roswell Park Cancer Institute Completed No outcome recorded
Phase 1 NCT01677650 Mar 2014 → Jan 2015 scoliosis Northwestern University Withdrawn No outcome recorded
Phase 1 NCT02045693 Feb → Apr 2014 hepatitis C virus infection Bristol-Myers Squibb Completed No outcome recorded
Phase 1 NCT01582425 Apr → Jun 2012 — Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05425420 Aug 2023 → Jan 2024 — Kanecia Obie Zimmerman Completed No outcome recorded
Phase 1/2 NCT01327079 Dec 2010 → Dec 2017 pulmonary immaturity John van den Anker Completed No outcome recorded
Phase 1/2 NCT01094522 Mar 2010 → Jun 2012 — Stanford University Completed No outcome recorded
Phase 216 trials · 3 missed
Phase 2 NCT06536517 Mar 2025 → Dec 2026 expected leiomyoma Johns Hopkins University Recruiting No outcome recorded
Phase 2 NCT04480554 Jan 2023 → Jun 2025 HIV infectious disease, opiate dependence University of Pennsylvania Terminated No outcome recorded Stop: Business
Phase 2 NCT03605901 Mar 2019 → May 2025 neuropathy, painful University of Florida Terminated Missed primary
Phase 2 NCT03908944 Jan 2019 → Jan 2021 — Steven Edelstein Withdrawn No outcome recorded
Phase 2 NCT03134703 Feb 2017 → Mar 2019 neonatal abstinence syndrome Johns Hopkins All Children's Hospital Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02774499 Apr → Aug 2016 — University of Saskatchewan Completed Missed primary
Phase 2 NCT01795495 Sep 2013 → Aug 2016 idiopathic scoliosis Nationwide Children's Hospital Completed Mixed
Phase 2 NCT01429181 Jan 2012 → Sep 2014 diabetic polyneuropathy MetaPharm, Inc. Completed No outcome recorded
Phase 2 NCT00863057 May 2009 → Dec 2010 HIV infectious disease, peripheral neuropathy National Institute of Allergy and Infectious Diseases (NIAID) Terminated Missed primary Stop: Enrollment
Phase 2 NCT00723918 Apr 2009 → Jan 2010 polyneuropathy Washington University School of Medicine Withdrawn No outcome recorded
Phase 2/34 trials
Phase 2/3 NCT05786599 Mar 2025 → Mar 2026 overdue chemotherapy-induced neuropathy University of British Columbia Recruiting No outcome recorded
Phase 2/3 NCT05693675 Oct 2023 → Jul 2024 — The University of Texas Health Science Center, Houston Withdrawn No outcome recorded Stop: Enrollment
Phase 2/3 NCT01082679 Jun 2009 → Mar 2011 opiate dependence University of Wisconsin, Madison Completed No outcome recorded
Phase 2/3 NCT00525967 Feb 2006 → Oct 2007 cancer Faculdade de Medicina do ABC Unknown No outcome recorded
Phase 322 trials · 2 met primary
Phase 3 NCT06940570 Jan 2028 → Aug 2029 aplastic anemia, bone marrow failure syndrome, leukemia, severe combined immunodeficiency University of Texas Southwestern Medical Center Suspended No outcome recorded Stop: Business
Phase 3 NCT07565870 Jul → Dec 2026 expected — Alexandre P. Joosten Not yet recruiting No outcome recorded
Phase 3 NCT06626035 Dec 2025 → Jan 2029 expected — Senthil Sadhasivam Recruiting No outcome recorded
Phase 3 NCT06626503 Oct 2025 → Jan 2029 expected idiopathic scoliosis Senthil Sadhasivam Recruiting No outcome recorded
Phase 3 NCT06351215 May → Dec 2025 overdue — Keck School of Medicine of USC Not yet recruiting No outcome recorded
Phase 3 NCT06593665 Sep 2024 → Dec 2026 expected testicular cancer Indiana University Recruiting No outcome recorded
Phase 3 NCT06728371 Mar → Dec 2024 overdue neuropathy, painful Chinese University of Hong Kong Recruiting No outcome recorded
Phase 3 NCT05913284 Jan 2024 → Feb 2026 overdue chronic pain syndrome, neuropathy, painful Chinese University of Hong Kong Active not recruiting No outcome recorded
Phase 3 NCT05831345 Feb 2023 → Dec 2025 overdue — Brugmann University Hospital Recruiting No outcome recorded
Phase 3 NCT05325164 Sep 2022 → Aug 2023 adenocarcinoma Ottawa Hospital Research Institute Withdrawn No outcome recorded
Phase 441 trials · 3 met primary
Phase 4 NCT07857655 Sep 2026 → Jul 2029 expected hypopharyngeal carcinoma, laryngeal carcinoma, oral cavity carcinoma, oropharyngeal carcinoma OHSU Knight Cancer Institute Recruiting No outcome recorded
Phase 4 NCT07517679 Jun 2026 → Apr 2027 expected — Brandon Knopp Recruiting No outcome recorded
Phase 4 NCT07485803 Jun 2026 → Apr 2028 expected — AdventHealth Recruiting No outcome recorded
Phase 4 NCT07546396 May 2026 → Mar 2027 expected substance-related disorder Pouya Azar Not yet recruiting No outcome recorded
Phase 4 NCT07365800 Apr → Dec 2026 expected upper thoracic spina bifida aperta University of Missouri-Columbia Enrolling by invitation No outcome recorded
Phase 4 NCT06868589 Jun 2025 → Jul 2026 overdue — Lahey Clinic Active not recruiting No outcome recorded
Phase 4 NCT06720415 Apr → Jul 2025 — Mayo Clinic Completed No outcome recorded
Phase 4 NCT06843174 Feb 2025 → Jul 2026 overdue — Unity Health Toronto Recruiting No outcome recorded
Phase 4 NCT06826742 Feb → Sep 2025 — Mayo Clinic Completed No outcome recorded
Phase 4 NCT06784999 Jan 2025 → Nov 2027 expected — Indiana University Recruiting No outcome recorded
Phase not applicable16 trials · 2 met primary · 1 missed
— NCT06240390 May → Aug 2024 neuropathy, painful Universidad Europea de Canarias Withdrawn No outcome recorded Stop: Enrollment
— NCT04475029 Jul 2020 → Aug 2023 nervous system disorder, neuropathy, painful, urinary bladder cancer University of Aarhus Completed No outcome recorded
— NCT03908060 May 2019 → Jul 2022 — University of Aarhus Unknown Met primary
— NCT03098407 Apr 2017 → Oct 2019 opiate dependence, pregnancy disorder University of Pittsburgh Completed No outcome recorded
— NCT02334215 Dec 2014 → Mar 2019 substance-related disorder Friends Research Institute, Inc. Completed Mixed
— NCT01160432 May → Jul 2013 opiate dependence Kuopio University Hospital Withdrawn No outcome recorded
— NCT01990573 Apr 2013 → Jun 2018 — Washington University School of Medicine Completed Mixed
— NCT01833715 Mar → Aug 2013 — Universidad de Valparaiso Completed No outcome recorded
— NCT01648283 Nov 2012 → Mar 2015 — Washington University School of Medicine Completed No outcome recorded
— NCT01430182 Sep 2011 → Jul 2014 — Baylor College of Medicine Terminated Missed primary Stop: Enrollment
Comparator or background therapy77 trials
Phase 0 NCT04308694 Background Aug 2020 → Jan 2021 substance-related disorder Friends Research Institute, Inc. Completed No outcome recorded
Phase 1 NCT05251376 Background Feb → Dec 2022 opiate dependence Lyndra Inc. Withdrawn No outcome recorded Stop: Business
Phase 1 NCT04112550 Comparator Feb 2020 → Dec 2021 intervertebral disk degenerative disorder, spondylolisthesis The Methodist Hospital Research Institute Unknown No outcome recorded
Phase 1 NCT02033707 Background Apr 2014 → Feb 2019 — Johns Hopkins University Completed No outcome recorded
Phase 1 NCT01723527 Background Dec 2012 → May 2014 HIV infectious disease, cocaine abuse, heroin dependence Johns Hopkins University Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 211 sources stand behind the page.

FieldValueCited text
Known as Methadone “Methadone 30 to 130 mg will be administered as a stable oral therapy from Day -14 to Day -1, in combination with telaprevir from Day 1 to Day 7, and then alone as a continued...” NCT00933283 ↗
205

“The program includes medication for opioid use disorder (methadone, buprenorphine/naloxone), standardized counseling sessions (BDRC) and HIV testing and care (for people living...” NCT05368675 ↗

“The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.” NCT00000328 ↗

“Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.” NCT04345718 ↗

“plus standard methadone maintenance (daily oral methadone and weekly individual counseling).” NCT00780702 ↗

“Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone)” NCT03472469 ↗

“Methadone: 0.5-0.1mg/kg IV at the beginning of the surgical incision (single dose)” NCT07558226 ↗

“Opioids: heroin, morphine, oxycodone, hydrocodone, methadone, codeine” NCT02033707 ↗

“Filibuvir, 600mg bid administered along with methadone on days 2-11” NCT01210404 ↗

“Methadone (Dolophine®, Methadose®)” NCT06240390 ↗

“Epidural methadone bolus 4mg” NCT00848419 ↗

Show 195 more sources

Known as Dolophine “methadone (Dolophine, a long-acting narcotic)” NCT02252432 ↗
1

“Methadone (Dolophine®, Methadose®)” NCT06240390 ↗

Known as MET “Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone syrup (MET)” NCT04480554 ↗
Known as Methadone HCl “Methadone HCl oral solution 5 mg/ml Methadone HCl inject 10 mg/ml (will require dilution)” NCT00715988 ↗
1

“IV racemic methadone HCl” NCT01648283 ↗

Known as methadone hydrochloride “Participants will be treated/monitored overnight with Methadone hydrochloride IV (FDA approved and commercially available), with daily follow-up visits for 1 week total.” NCT05425420 ↗
12

“Methadone hydrochloride (0.10 mg/kg) administered intravenously at the induction of anaesthesia” NCT06086171 ↗

“Epidural bolus of 4mg of preservative free methadone hydrochloride (4mL of 1mg/mL solution)” NCT03525509 ↗

“Drug: methadone hydrochloride” NCT00726830 ↗

“Drug: Methadone hydrochloride” NCT06962306 ↗

“Drug: Methadone Hydrochloride” NCT04112550 ↗

“Drug: Methadone hydrochloride” NCT06877858 ↗

“Drug: Methadone Hydrochloride” NCT02989597 ↗

“Drug: Methadone Hydrochloride” NCT04680286 ↗

“Methadone Hydrochloride” NCT07296770 ↗

NCT05831345 ↗

Show 2 more sources

Known as Methadose “Methadone (Dolophine®, Methadose®)” NCT06240390 ↗
Known as Methadose/ Metadol D/Compounded methadone “Methadose/ Metadol D/Compounded methadone” NCT03948464 ↗
Action Activate “Substitution with opioid-agonists (e.g., methadone) has shown to be an effective treatment for chronic long-term opioid dependency.” PMID 22276954 ↗ Jan 2012
Modality Other / unclassified “Methadone is a synthetic opioid analgesic” NCT02989597 ↗
Route Oral “The effects of p.o. methadone or sublingual buprenorphine maintenance on i.v. cocaine self-administration” PMID 8819498 ↗ Sep 1996