Substance Use DisorderNCT05448118
Virtual MOUD Treatment- Virtual POC Toxicology
A study testing Virtual POC Toxicology Test in people with Substance Use Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- Virtual POC Toxicology Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Veterans must not be receiving inpatient or day-program treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
Official title: Virtual MOUD Treatment: Virtual Point-of-Care Toxicology Testing to Accompany Virtual Medication Assisted Treatment for Opioid Use Disorder
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.
Read the detailed 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.
- Conditions
- Substance Use Disorder
- Being tested
- Virtual POC Toxicology Test
- Keywords
- Substance Use Disorder, Opioid Use Disorder, Telemedicine, Toxicology
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual POC Toxicology TestDiagnostic test
Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits.
| Study group | Role | What they receive |
|---|---|---|
| Virtual POC Toxicology Testing | Experimental | Providers and patients will use Saliva Toxicology test at the point of care during virtual care visits. Receives: Diagnostic Test: Virtual POC Toxicology Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure
The Acceptability of intervention measure is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.
Measured: at enrollment and between 2 and 3 months following enrollment
Semi-Structured Interview of Toxicology Testing Process Acceptability
Semi-Structured interview of toxicology testing Process Acceptability based on the Consolidated Framework for Implementation Research, transcribed and analyzed qualitatively for key themes.
Measured: Through study completion or 3-months post enrollment, whatever comes first
Secondary outcomes (3)
The Substance Abuse Perceived Stigma Scale
The Substance Abuse Perceived Stigma Scale (SAPSS) is a 12-item questionnaire that assesses the construct of perceived stigma. Items are scored on seven point Likert-type scale where 1 = never and 7 = always with agreement indicating non-stigmatizing behavior or attitudes. The scale is scored by reverse scoring each item, summing the items, and dividing by 12, thus higher scores indicate more perceived stigma.
Measured: at enrollment and between 2 and 3 months following enrollment
Helping Alliance questionnaire
Helping Alliance questionnaire (HAq-II) is a 19-item questionnaire that measures the strength of the patient-therapist therapeutic alliance. Each item is rated on a 6-point Likert scale (1 = I strongly feel it is not true, 6 = I strongly feel it is true). Negatively worded items are reverse scored.
Measured: at enrollment and between 2 and 3 months following enrollment
Health service use
toxicology testing episodes and substance use disorder treatment contacts will be extracted from the electronic medical record. Toxicology testing episodes will be measured as a proportion of SUD treatment encounters over a 6 month period following enrollment and Substance use disorder treatment contacts will be summed over a 6 month period following enrollment.
Measured: 6 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Sep 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Why it stopped: This Pilot implementation Trial was never started because no providers were found who would agree to use saliva-based toxicology tests in care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A virtual point-of-care toxicology testing process will be evaluated in a single arm pilot trial among providers and patients at VACT and VACWM. Acceptability will be evaluated through patient and provider semi-structured interviews. Overall feasibility will be determined by evaluating virtual toxicology testing utilization, as well as the frequency of toxicology testing and of addiction treatment contacts.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Eric Hermes, MD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448118
- Sponsor's protocol ID
- SDR 21-114
- Status last verified
- Dec 2023
- First submitted
- 24 Jun 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual MOUD Treatment: Virtual Point-of-Care Toxicology Testing to Accompany Virtual Medication Assisted Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05448118
- Acronym / sponsor ID
- SDR 21-114
- Conditions
- Substance Use Disorder
- Keywords
- Substance Use Disorder, Opioid Use Disorder, Telemedicine, Toxicology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This Pilot implementation Trial was never started because no providers were found who would agree to use saliva-based toxicology tests in care
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A virtual point-of-care toxicology testing process will be evaluated in a single arm pilot trial among providers and patients at VACT and VACWM. Acceptability will be evaluated through patient and provider semi-structured interviews. Overall feasibility will be determined by evaluating virtual toxicology testing utilization, as well as the frequency of toxicology testing and of addiction treatment contacts.
| Arm | Type | Receives |
|---|---|---|
| Virtual POC Toxicology Testing | Experimental | Diagnostic Test: Virtual POC Toxicology TestProviders and patients will use Saliva Toxicology test at the point of care during virtual care visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (1 listed)
- Veterans must not be receiving inpatient or day-program treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual POC Toxicology TestProviders and patients will use Saliva Toxicology test at the point of care during virtual care visits. | Diagnostic test | Virtual POC Toxicology Testing |
Primary outcome
Acceptability of Intervention Measure
Time frame: at enrollment and between 2 and 3 months following enrollment
The Acceptability of intervention measure is a 4-item measure scored on a 5-point scale and summed. The Range of Scores is from 4 to 20. Higher Scores indicate higher acceptability.
Semi-Structured Interview of Toxicology Testing Process Acceptability
Time frame: Through study completion or 3-months post enrollment, whatever comes first
Semi-Structured interview of toxicology testing Process Acceptability based on the Consolidated Framework for Implementation Research, transcribed and analyzed qualitatively for key themes.
3 secondary outcomes
The Substance Abuse Perceived Stigma Scale
Time frame: at enrollment and between 2 and 3 months following enrollment
Helping Alliance questionnaire
Time frame: at enrollment and between 2 and 3 months following enrollment
Health service use
Time frame: 6 months following enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hermes, MD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual POC Toxicology Test in people with Substance Use Disorder, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (time frame: at enrollment and between 2 and 3 months following enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.