Recruiting
Phase 2

Methadone

Sponsor:

Sonara Health

Code:

NCT06338280

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Sonara

Study Details

Brief summary:

Methadone is an effective treatment for severe opioid use disorder (OUD), but access is limited due to the requirement of daily observed dosing by most opioid treatment programs (OTPs). Sonara Health designed a HIPAA-compliant web-application called Sonara that features integrated video dosing recording, a tamper-evident seal, and an innovative measurement-based care (MBC) framework called the Opioid Craving Visual Analogue Scale (OC-VAS) to facilitate methadone take-homes while providing evidence of appropriate use and monitoring patient outcomes. Phase II of this SBIR aims to compare Sonara against usual take-homes to assess its impact on retention in care, opioid use, patient outcomes, and costs of care.

Conditions

Opioid Use Disorder

Study ID

NCT06338280

Start date

Dec 24, 2024

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willing to participate in a randomized trial
  • Able to complete study instruments and interviews

Exclusion criteria:

  • Less than 18 years of age
  • Pregnant or planning to be pregnant
  • Currently involved in the criminal justice system
  • Serious mental health problems
  • Treated with buprenorphine

Please note: The enrollment target (2.5 randomizations per week over 50 weeks) includes oversampling women and under-represented racial/ethnicity groups (i.e., at least 10 or more individuals per group who identify as Black, Hispanic, and American Indian/Alaskan Native).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Sonara-enabled

no intervention: Treatment as usual

Interventions

Sonara

Sonara virtual dosing window and engagement platform

Primary outcome measure

  • Retention [ Time Frame: 24 weeks ]
  • Take homes received over time [ Time Frame: 24 weeks ]

Central Contacts and Locations

Locations

FGC Wabash

Recruiting

Chicago, Illinois, United States, 75220

Contacts

Michael Dennis, PhD

888-924-3786mdennis@chestnut.org

More Information

Sponsor

Sonara Health

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sonara Health on 2026-03-27.