Opioid UseNCT07603778
Voice Technology to Identify Opioid Use
An observational study of Opioid Use, run by Tenvos Inc. at 1 site in United States.
Trial summary
This study explored whether changes in a person's voice could help identify opioid use in patients with opioid use disorder (OUD). Current methods for determining whether a patient is intoxicated or in withdrawal often rely on self-reporting and clinical judgment, which can be subjective and inconsistent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use
- What is being tested?
- Not applicable- observational study
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2024to 30 Jan 2026
- Phase
- Observational
- 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
Study population: The study population is adult (18+) English-speaking men and women currently receiving OUD treatment at the Volpicelli Center, capable of consenting and completing the protocol, and free of severe psychiatric comorbidity or chronic speech-affecting conditions. Because participants are drawn from an active treatment population, they are by definition individuals already engaged in care for OUD rather than treatment-naïve or general-population samples - a relevant consideration when interpreting how the voice biomarker findings might generalize.
Who may be able to join
- Male or female
- At least 18 years old
- Be an active patient in treatment at the Volpicelli Center
- Have a diagnosis of Opioid Use Disorder (OUD)
- Ability to read English
- Able to comprehend and are willing to sign the informed consent form and are able to adhere to the protocol
Who cannot join
- Severe psychiatric comorbidity
- A chronic medical condition that interferes with speaking (note: Acute conditions that impair speech or hearing will not be considered exclusionary, but testing will be deferred until the temporary condition has been resolved)
- Non-fluency in the study language (English)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health, 24951 Circle Drive, Nichol Hall, Room #2042
Loma Linda, California, 92350
About this study
Official title: Using Voice Technology to Identify Opioid Use in Patients in Treatment for Opioid Use Disorder
This study explored whether changes in a person's voice could help identify opioid use in patients with opioid use disorder (OUD). Current methods for determining whether a patient is intoxicated or in withdrawal often rely on self-reporting and clinical judgment, which can be subjective and inconsistent. Drug tests are logistically challenging to administer and can be costly with repeated use.
The project investigated whether physiological changes associated with opioid use could be detected through speech analysis technology. Researchers evaluated whether machine learning methods could identify voice patterns associated with opioid intoxication or withdrawal.
The primary goal of the study was to assess the accuracy of voice-based biomarkers in identifying opioid use. The study also explored relationships between opioid use and specific speech characteristics.
Read the detailed description
This study investigated whether changes in a person's voice could be used to identify opioid use in individuals with opioid use disorder (OUD). The opioid epidemic continues to present significant public health, medical, and social challenges in the United States and globally. Clinicians treating patients with OUD often need to determine whether a patient may be actively using opioids, intoxicated, withdrawing, or responding appropriately to treatment. Current approaches commonly rely on self-reporting, interviews, behavioral observations, urine toxicology testing, and clinical judgment. While these methods can be useful, they may also be subjective, resource-intensive, intermittent, invasive, or difficult to implement frequently in routine care settings.
The purpose of this project was to evaluate whether speech analysis technology could provide a more objective, scalable, and non-invasive approach for monitoring opioid-related physiological changes. Human speech is a complex neuromuscular activity that depends on the coordinated function of the brain, respiratory system, vocal tract, and facial musculature. Opioids can affect cognitive processing, respiratory patterns, motor coordination, reaction time, sedation levels, and muscle control, all of which may influence characteristics of speech production. Prior scientific literature has suggested that physiological and neurological conditions can sometimes produce measurable changes in speech patterns. This project sought to determine whether similar measurable changes could be associated with opioid use.
The study focused specifically on analyzing speech recordings from participants with opioid use disorder. Researchers collected voice samples and applied computational analysis methods to evaluate whether acoustic and temporal speech features could distinguish opioid-related states. The project used signal-processing techniques and machine learning methods to analyze a range of speech characteristics that may reflect physiological effects associated with opioid exposure.
Evaluated speech features included acoustic biomarkers commonly studied in speech analytics research. The project investigated whether combinations of these features could be used to identify patterns associated with opioid intoxication or withdrawal.
A major goal of the study was to assess the feasibility of using speech as a physiological biomarker for opioid use monitoring. Researchers evaluated whether machine learning models could reliably differentiate between opioid-related conditions using speech data alone.
The primary objective of the study was to assess the accuracy and feasibility of voice-based biomarkers for identifying opioid use in individuals with OUD. The study also aimed to better understand the limitations and challenges associated with speech-based impairment detection.
As part of the research effort, the project contributed to the development of internal workflows and analytic infrastructure for handling sensitive speech data. Researchers established preprocessing pipelines for audio ingestion, normalization, feature extraction, labeling, quality control, and model evaluation.
The work generated technical findings regarding the feasibility of speech-based opioid detection and highlighted several scientific and engineering challenges associated with this problem space. These included variability in recording environments, differences between speakers, background noise, individual physiological differences, and the difficulty of isolating opioid-related speech effects from unrelated sources of variation. The study also reinforced the challenges associated with developing generalized machine learning classifiers for complex real-world physiological states using speech data alone.
Although the project explored the potential for objective opioid monitoring through speech analysis, the research did not produce a clinically deployable classifier during the study period. However, the project generated valuable information regarding the limitations, feasibility considerations, and technical barriers associated with speech-based opioid detection approaches. These findings informed future research planning, technology-development decisions, and evaluation strategies for impairment-detection technologies.
Overall, the project contributed to ongoing research efforts exploring non-invasive digital biomarkers for substance-use monitoring. The findings from this work may help guide future investigations into speech analytics, physiological monitoring, and machine learning approaches for identifying substance-related impairment and supporting clinical decision-making in addiction medicine settings.
- Conditions
- Opioid Use
- Being tested
- Not applicable- observational study
- Keywords
- Voice Biomarkers, Opioids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not Applicable - Observational Study
| Study group | Role | What they receive |
|---|---|---|
| Patients in treatment for opioid use disorder at the Volpicelli Center. | Prospective longitudinal observational cohort study with repeated measures where each participant completed two visits approximately 30 days apart with repeated speech and clinical measurements. This is a prospective observational study therefore no intervention will be applied. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Sensitivity and Specificity of the machine learning model when classifying voice samples into patient's state based on their speech.
Measured: 12 months after the enrollment
Secondary outcomes (1)
List of specific voice features/categories affected by substances
Identify voice features/categories most affected by the following substances: Buprenorphine, Other Opioid, Opioid Antagonist, Stimulant, Sedative, Cannabinoid.
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start10 Dec 2024
- Primary completion30 Jun 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tenvos Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Volpicelli Center, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603778
- Sponsor's protocol ID
- 0612
- Other IDs
- 1R43DA060696-01
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Voice Technology to Identify Opioid Use in Patients in Treatment for Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT07603778
- Acronym / sponsor ID
- 0612
- Conditions
- Opioid Use
- Keywords
- Voice Biomarkers, Opioids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Tenvos Inc.Industry (pharma, biotech, devices)
- Collaborators
- Volpicelli Center, National Institute on Drug Abuse (NIDA)
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 22 May 2026 (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.
This study explored whether changes in a person's voice could help identify opioid use in patients with opioid use disorder (OUD). Current methods for determining whether a patient is intoxicated or in withdrawal often rely on self-reporting and clinical judgment, which can be subjective and inconsistent. Drug tests are logistically challenging to administer and can be costly with repeated use.
The project investigated whether physiological changes associated with opioid use could be detected through speech analysis technology. Researchers evaluated whether machine learning methods could identify voice patterns associated with opioid intoxication or withdrawal.
The primary goal of the study was to assess the accuracy of voice-based biomarkers in identifying opioid use. The study also explored relationships between opioid use and specific speech characteristics.
Detailed description
This study investigated whether changes in a person's voice could be used to identify opioid use in individuals with opioid use disorder (OUD). The opioid epidemic continues to present significant public health, medical, and social challenges in the United States and globally. Clinicians treating patients with OUD often need to determine whether a patient may be actively using opioids, intoxicated, withdrawing, or responding appropriately to treatment. Current approaches commonly rely on self-reporting, interviews, behavioral observations, urine toxicology testing, and clinical judgment. While these methods can be useful, they may also be subjective, resource-intensive, intermittent, invasive, or difficult to implement frequently in routine care settings.
The purpose of this project was to evaluate whether speech analysis technology could provide a more objective, scalable, and non-invasive approach for monitoring opioid-related physiological changes. Human speech is a complex neuromuscular activity that depends on the coordinated function of the brain, respiratory system, vocal tract, and facial musculature. Opioids can affect cognitive processing, respiratory patterns, motor coordination, reaction time, sedation levels, and muscle control, all of which may influence characteristics of speech production. Prior scientific literature has suggested that physiological and neurological conditions can sometimes produce measurable changes in speech patterns. This project sought to determine whether similar measurable changes could be associated with opioid use.
The study focused specifically on analyzing speech recordings from participants with opioid use disorder. Researchers collected voice samples and applied computational analysis methods to evaluate whether acoustic and temporal speech features could distinguish opioid-related states. The project used signal-processing techniques and machine learning methods to analyze a range of speech characteristics that may reflect physiological effects associated with opioid exposure.
Evaluated speech features included acoustic biomarkers commonly studied in speech analytics research. The project investigated whether combinations of these features could be used to identify patterns associated with opioid intoxication or withdrawal.
A major goal of the study was to assess the feasibility of using speech as a physiological biomarker for opioid use monitoring. Researchers evaluated whether machine learning models could reliably differentiate between opioid-related conditions using speech data alone.
The primary objective of the study was to assess the accuracy and feasibility of voice-based biomarkers for identifying opioid use in individuals with OUD. The study also aimed to better understand the limitations and challenges associated with speech-based impairment detection.
As part of the research effort, the project contributed to the development of internal workflows and analytic infrastructure for handling sensitive speech data. Researchers established preprocessing pipelines for audio ingestion, normalization, feature extraction, labeling, quality control, and model evaluation.
The work generated technical findings regarding the feasibility of speech-based opioid detection and highlighted several scientific and engineering challenges associated with this problem space. These included variability in recording environments, differences between speakers, background noise, individual physiological differences, and the difficulty of isolating opioid-related speech effects from unrelated sources of variation. The study also reinforced the challenges associated with developing generalized machine learning classifiers for complex real-world physiological states using speech data alone.
Although the project explored the potential for objective opioid monitoring through speech analysis, the research did not produce a clinically deployable classifier during the study period. However, the project generated valuable information regarding the limitations, feasibility considerations, and technical barriers associated with speech-based opioid detection approaches. These findings informed future research planning, technology-development decisions, and evaluation strategies for impairment-detection technologies.
Overall, the project contributed to ongoing research efforts exploring non-invasive digital biomarkers for substance-use monitoring. The findings from this work may help guide future investigations into speech analytics, physiological monitoring, and machine learning approaches for identifying substance-related impairment and supporting clinical decision-making in addiction medicine settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in treatment for opioid use disorder at the Volpicelli Center. | – | Other: Not applicable- observational studyProspective longitudinal observational cohort study with repeated measures where each participant completed two visits approximately 30 days apart with repeated speech and clinical measurements. This is a prospective observational study therefore no intervention will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is adult (18+) English-speaking men and women currently receiving OUD treatment at the Volpicelli Center, capable of consenting and completing the protocol, and free of severe psychiatric comorbidity or chronic speech-affecting conditions. Because participants are drawn from an active treatment population, they are by definition individuals already engaged in care for OUD rather than treatment-naïve or general-population samples - a relevant consideration when interpreting how the voice biomarker findings might generalize.
Key inclusion criteria (6 listed)
- Male or female
- At least 18 years old
- Be an active patient in treatment at the Volpicelli Center
- Have a diagnosis of Opioid Use Disorder (OUD)
- Ability to read English
Key exclusion criteria (3 listed)
- Severe psychiatric comorbidity
- A chronic medical condition that interferes with speaking (note: Acute conditions that impair speech or hearing will not be considered exclusionary, but testing will be deferred until the temporary condition has been resolved)
- Non-fluency in the study language (English)
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 |
|---|---|---|
| Not applicable- observational studyNot Applicable - Observational Study | Other | Patients in treatment for opioid use disorder at the Volpicelli Center. |
Primary outcome
Sensitivity and Specificity
Time frame: 12 months after the enrollment
Sensitivity and Specificity of the machine learning model when classifying voice samples into patient's state based on their speech.
1 secondary outcome
List of specific voice features/categories affected by substances
Time frame: 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- GitHub Repository with software code for extracting acoustic features, Montreal Forced Alignment and Audio Transcription (a.k.a. pre-processing pipeline).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use, run by Tenvos Inc. at 1 site 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 3 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and Specificity (time frame: 12 months after the enrollment). 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 22 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.