Last reviewed · How we verify

NCT04180020: COMMIT

Coordinating Opioid Use Treatment Through Medical Management With Infection Treatment (Project COMMIT)

Completed NA Results posted Last updated 3 April 2025
What this trial tests

NA trial testing ID/LAB in Opioid-use Disorder in 171 participants. Completed in 25 April 2024.

Timeline
18 August 2020
Primary endpoint
6 February 2024
25 April 2024

Quick facts

Lead sponsorYale University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment171
Start date18 August 2020
Primary completion6 February 2024
Estimated completion25 April 2024
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Yale University

Who can join

18 and older, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Retention in Medication Treatment for OUD Primary · 12 weeks

Enrollment in effective medication treatment for OUD (either buprenorphine maintenance, methadone maintenance, or extended-release naltrexone) will be ascertained through interview of the participant at each assessment point, using a modified, brief version of the Treatment Services Review that records type and dose of medication treatment, contact information on the treatment program, and psychosocial treatment modalities accessed since the previous visit (e.g. professional counseling, 12-step group participation). The primary outcome will be a binary indicator of whether or not the patient

GroupValue95% CI
Treatment as Usual (TAU).46
ID/LAB51

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment as Usual (TAU).
Serious: 20/85 (24%)
Deaths: 4/85
ID/LAB
Serious: 31/86 (36%)
Deaths: 4/86

Serious adverse events (9 terms)

ReactionSystemTreatment as Usual (TAU).ID/LAB
Skin/soft tissue infectionSkin and subcutaneous tissue disorders
Respiratory failureRespiratory, thoracic and mediastinal disorders
AnemiaBlood and lymphatic system disorders
Respiratory infection (not including COVID-19)Infections and infestations
Non-fatal opioid overdoseNervous system disorders
Opioid WithdrawalNervous system disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Abdominal painGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Other adverse events (21 terms — click to expand)

ReactionSystemTreatment as Usual (TAU).ID/LAB
Opioid WithdrawalNervous system disorders
NauseaGastrointestinal disorders
Skin/soft tissue infectionSkin and subcutaneous tissue disorders
HeadacheNervous system disorders
Injection site reactionGeneral disorders
ArthralgiaMusculoskeletal and connective tissue disorders
RashSkin and subcutaneous tissue disorders
ConstipationGastrointestinal disorders
EdemaVascular disorders
Abdominal painGastrointestinal disorders
MyalgiaMusculoskeletal and connective tissue disorders
Non-fatal opioid overdoseNervous system disorders
FatigueGeneral disorders
AnemiaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
DiaphoresisGeneral disorders
FeverImmune system disorders
InsomniaNervous system disorders
Back painMusculoskeletal and connective tissue disorders
Respiratory infection (not including COVID-19)Infections and infestations

Most-reported serious reactions: Skin/soft tissue infection, Respiratory failure, Anemia, Respiratory infection (not including COVID-19), Non-fatal opioid overdose, Opioid Withdrawal, Arthralgia, Abdominal pain.

Data from ClinicalTrials.gov NCT04180020 adverse events section.

Sponsor's own description

This study seeks to test a new model of care (ID/LAB) in which opioid use disorder (OUD) is managed by infectious disease (ID) specialists and hospitalists concurrent with management of the OUD-related infections, using long-acting injectable buprenorphine (LAB), followed by referral as soon as possible after hospital discharge to community resources for long term treatment of OUD.

Publications & conference data

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

  1. Design and methods of a multi-site randomized controlled trial of an integrated care model of long-acting injectable buprenorphine with infectious disease treatment among persons hospitalized with infections and opioid use disorder.
    Seval N, Frank CA, Litwin AH, Roth P, et al · · 2021 · cited 12× · PMID 33838307 · DOI 10.1016/j.cct.2021.106394
  2. Inpatient Low-dose Transitions From Full Agonist Opioids Including Methadone Onto Long-acting Depot Buprenorphine: Case Series From a Multicenter Clinical Trial.
    Seval N, Nunez J, Roth P, Schade M, et al · · 2023 · cited 10× · PMID 37579095 · DOI 10.1097/adm.0000000000001136
  3. Missed Opportunities for Preexposure Prophylaxis Initiation in Hospitalized Persons With Opioid Use Disorder and Infectious Diseases.
    Parchinski K, Neirinckx V, Frank C, Di Paola A, et al · · 2024 · cited 2× · PMID 39022389 · DOI 10.1093/ofid/ofae366
  4. Initiating Injectable Buprenorphine in People Hospitalized With Infections: A Randomized Clinical Trial.
    Seval N, Roth P, Frank CA, Di Paola A, et al · · 2025 · cited 1× · PMID 40445619 · DOI 10.1001/jamanetworkopen.2025.13000

Verify or expand the search:

Other recruiting trials for Opioid-use Disorder

Currently open trials in the same condition.

Other Yale University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT04180020.

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