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Opioid UseNCT07603778

Voice Technology to Identify Opioid Use

An observational study of Opioid Use, run by Tenvos Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT07603778
Study groupRoleWhat 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.

  1. 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)
  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.

  1. First posted22 May 2026
  2. Study start10 Dec 2024
  3. Primary completion30 Jun 2025
  4. Study completion30 Jan 2026

Resources

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)
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

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.

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