NCT04523922 (COPE+OT) is a Phase 2 clinical trial of 40 IU Intranasal Oxytocin in PTSD, sponsored by Medical University of South Carolina.

Who is sponsoring NCT04523922?

NCT04523922 is sponsored by Medical University of South Carolina.

What drugs are being tested in NCT04523922?

Interventions in NCT04523922: 40 IU Intranasal Oxytocin, Placebo, Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure.

What condition does NCT04523922 study?

NCT04523922 studies PTSD, Alcohol Use Disorder.

Is NCT04523922 still recruiting?

NCT04523922 is currently active, enrolled. Last updated 9 April 2026.

Last reviewed 2026-04-09 · How we verify

NCT04523922: COPE+OT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oxytocin to Enhance Integrated Treatment for AUD and PTSD

Active, enrolled Phase 2 Last updated 9 April 2026

What this trial tests

Phase 2 trial testing 40 IU Intranasal Oxytocin in PTSD in 175 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 March 2021

Primary endpoint
1 June 2026

1 December 2026

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	175
Start date	29 March 2021
Primary completion	1 June 2026
Estimated completion	1 December 2026
Sites	1 location across United States

Drugs / interventions tested

40 IU Intranasal Oxytocin — full drug profile →
Placebo
Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure

Conditions studied

PTSD — all drugs for PTSD →
Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 70, any sex, with PTSD or Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objective of the proposed Stage II study is to examine the efficacy of oxytocin (OT) as compared to placebo in reducing (1) alcohol use disorder (AUD) symptoms, and (2) post-traumatic stress disorder (PTSD) symptoms among Veterans receiving COPE therapy (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure). To evaluate purported neurobiological mechanisms of change, we will employ functional magnetic resonance imaging (fMRI) at pre- and post-treatment.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

The future of psychopharmacology: a critical appraisal of ongoing phase 2/3 trials, and of some current trends aiming to de-risk trial programmes of novel agents.
Correll CU, Solmi M, Cortese S, Fava M, et al · · 2023 · cited 90× · PMID 36640403 · DOI 10.1002/wps.21056
Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418
COPE and oxytocin for the treatment of co-occurring PTSD and alcohol use disorder: Design and methodology of a randomized controlled trial in U.S. military veterans.
Back SE, Flanagan JC, Killeen T, Saraiya TC, et al · · 2023 · cited 5× · PMID 36646315 · DOI 10.1016/j.cct.2023.107084
Orphan peptide and G protein-coupled receptor signalling in alcohol use disorder.
Anversa RG, Maddern XJ, Lawrence AJ, Walker LC. · · 2024 · cited 4× · PMID 38073127 · DOI 10.1111/bph.16301
Emerging medications and pharmacological treatment approaches for substance use disorders.
Raymond JS, Athanasopoulos AG, Badolato CJ, Doolan TJ, et al · · 2025 · cited 2× · PMID 39719161 · DOI 10.1016/j.pbb.2024.173952

Verify or expand the search:

Other recruiting trials for PTSD

Currently open trials in the same condition.

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NCT07469098 — Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events · Phase 2 · recruiting

Other Medical University of South Carolina trials

Trials by the same sponsor.

NCT06491264 — Multiparameter Optimized tES for Memory in Aging · NA · withdrawn
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NCT07149207 — Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors · Phase 2 · recruiting
NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04523922 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
Last refreshed: 9 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04523922.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing