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Virtual MOUD Treatment- Virtual POC Toxicology

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VA Office of Research and Development

Status

Withdrawn

Conditions

Substance Use Disorder

Treatments

Diagnostic Test: Virtual POC Toxicology Test

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT05448118
SDR 21-114

Details and patient eligibility

About

Care for Substance use disorders (SUD) such as Medication treatment of Opioid Use Disorder (MOUD) saves lives and is increasingly delivered virtually. Currently, 60% of VA outpatient addiction treatment occurs over video. However, toxicology testing, a major component of SUD care, currently requires in-person visits. A process for virtual point-of-care toxicology testing is needed. This research will develop a Virtual Point-of-Care Toxicology Testing Process for VA. This Pilot Trial will evaluate the feasibility, acceptability, and proximal effects of the process by evaluating provider and patient testing uptake, qualitative feedback, and health service use.

Full description

Care for Substance use disorders (SUD) such as Medication treatment of Opioid Use Disorder (MOUD) saves lives and is increasingly delivered virtually. Currently, 60% of VA outpatient addiction treatment occurs over video. However, toxicology testing, a major component of MOUD care, currently requires in-person visits. A process for virtual point-of-care toxicology testing is needed. The objectives of this pilot project are to develop, feasibility test, and describe the proximal outcomes of a Virtual Point-of-Care Toxicology Testing Process for VA patients in MOUD care.

The process will be evaluated in a pilot trial among providers and patients at VA Connecticut (VACT) and VA Central Western Massachusetts (VACWM). Acceptability will be evaluated through patient and provider semi-structured interviews. Overall feasibility will be determined using a priori benchmarks of utilization. These findings will be used to inform modifications of virtual toxicology testing procedures.

Mixed-methods will be used to develop and evaluate the testing process, which will use an oral-fluid test for common drugs of abuse. The test is FDA approved for at home patient use. Patients will self-administer the test during virtual SUD visits and assess results with providers. In the pilot trial, a single-arm mixed-methods pilot trial will evaluate the process among patients and providers at two VA facilities. Feasibility will be evaluated by examining process uptake. Acceptability will be evaluated through semi-structured interviews with patients and providers based on Consolidated Framework for Implementation Research (CFIR) constructs. Health service use will be evaluated by analyzing data on patient characteristics, test utilization, and treatment contacts extracted from the electronic medical record.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To participate VA patients must

  • be recruited by their provider through a discussion about the project
  • be interested in participating after the discussion
  • have used VA video-based care at least once
  • receive buprenorphine from a VACT or VAWCM provider (50% will have started buprenorphine within the last 3 months)
  • have the ability to receive mail from the VA for the purposes of receiving oral fluid test kits)

Exclusion criteria

  • Veterans must not be receiving inpatient or day-program treatment

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Virtual POC Toxicology Testing
Experimental group
Description:
Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.
Treatment:
Diagnostic Test: Virtual POC Toxicology Test

Trial contacts and locations

2

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Central trial contact

Kimberly A Minnix; Eric Hermes, MD

Data sourced from clinicaltrials.gov

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