Substance Use Disorders (SUDs)NCT06995885
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
An observational study of Substance Use Disorders (SUDs), run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: A Timeline Follow-Back (TLFB) is a tool that helps researchers track how much of a substance a person uses. Different versions of the tool are used to track the use of alcohol, cigarettes, and cannabis. But there is no TLFB to track a person s use of nonmedical opioids. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance Use Disorders (SUDs)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We may enroll participants in this protocol from the pool that screens for other protocols at the NIDA IRP. We may also advertise for this protocol directly. If we decide to launch an ad campaign for this specific protocol, we will primarily recruit in the Baltimore metro area. We may also recontact previous participants from NIDA IRP studies who have expressed interest in participating in future NIDA studies and agreed to such recontact. Additionally, study team members attend events hosted by the Office of the Clinical Director to engage with local community partners. This includes clinics, treatment facilities, medical facilities, advocacy groups, and local businesses. We conduct outreach at community events/locations such as health expos, festivals, and other local venues. During these events, we display and offer approved recruitment materials.
Who may be able to join
- To be eligible to participate in this study, an individual must meet the following criteria:
- Age 18 years or older
- Self-report of current use of opioids obtained in a nonmedical context (i.e., not from a pharmacy or in a healthcare setting), at least once a week.
- Able to understand and communicate in written and spoken English.
- Justification: Initial development of the OpiTLFB requires strong, unmediated communication between the study team and the participants. Further development and modification for non-English-speaking interviewees is best undertaken as a separate project when the OpiTLFB is ready for use.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Who cannot join
- 1. Any medical, psychiatric, or social conditions that the investigators believe would make participation in this protocol not in the best interest of the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institute on Drug Abuse
Baltimore, Maryland, 21224
About this study
Background:
A Timeline Follow-Back (TLFB) is a tool that helps researchers track how much of a substance a person uses. Different versions of the tool are used to track the use of alcohol, cigarettes, and cannabis. But there is no TLFB to track a person s use of nonmedical opioids. (These are opioids not obtained from a medical source; they may also be called "street" opioids.) Researchers are creating an Opioid TLFB (OpiTLFB) that asks better questions and records more useful answers to identify what kinds of nonmedical opioids people are using.
Read more
Objective:
To test a new research tool to track a person's use of nonmedical opioids.
Eligibility:
People aged 18 years or older who currently use opioids nonmedically at least once a week.
Design:
Participants will have 1 study visit at a clinic in Baltimore, Maryland. The visit will take 1 to 4 hours.
Participants will sit at a computer with a researcher and fill out a calendar. They will record their use of opioids each day for the past 30 days. They will be asked what the drugs were called and what they looked like. This task might take 30 minutes.
Participants will be interviewed. The researcher will ask about their experiences getting opioids from friends, dealers, or other sources; how the experience of getting opioids has changed over time; and about any changes they have noticed across different areas of Baltimore. Researchers will ask how the OpiTLFB could be easier to fill out and how it could provide more useful information. This task might take 30 minutes.
Participants will provide a urine sample.
Read the detailed description
Study Description:
Observational, on-site study for the purpose of instrument development. Currently used assessments of recent opioid use do not reflect the current market for street opioids. This protocol will use semistructured interviews (supplemented with results from comprehensive toxicology of approximately 1,200 analytes in urine) to develop a workable typology of the current street-opioid market in the Baltimore region, and a TLFB calendar that asks germane questions and offers usable response options for products and amounts.
Objectives:
- To conduct semistructured interviews with people who use opioids (PWUOs) in the Baltimore area about their recent opioid use, for development of a TLFB instrument that assesses use in terms that accord with the current conditions of the market.
- To perform comprehensive toxicology testing so that an appearancedriven and effect-driven typology of street opioids can be tentatively mapped onto their likely contents.
Endpoints:
- At least three consecutive respondents (after an initial minimum of 25 respondents) for whom the OpiTLFB needs no further modification to capture their pattern of opioid use.
- Associations between OpiTLFB indices (name, physical appearance, and effects of product) and urine-toxicology results.
- Conditions
- Substance Use Disorders (SUDs)
- Keywords
- People who use opioids (PWUOs), Opioids, Timeline Follow-Back (TLFB)
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People who use opioids (PWUOs) | Current use of an opioid obtained in a nonmedical context (i.e., not from a pharmacy or in a healthcare setting), at least weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least three consecutive respondents (after an initial minimum of 25 respondents) for whom the OpiTLFB needs no further modification to capture their pattern of opioid use.
Existing TLFB measures assess opioid use in terms that no longer match what PWUOs can actually obtain. This hampers both baseline characterization and quantification of opioid-use changes in study participants.
Measured: 6-24 months
Associations between OpiTLFB indices (name, physical appearance, and effects of product) and urine-toxicology results.
This will help ensure that our typology of street opioids reflects real and consistent differences in product composition.
Measured: 6-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start2 Nov 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorders (SUDs)Studies 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
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David H Epstein, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995885
- Sponsor's protocol ID
- 10002297
- Other IDs
- 002297-DA
- Status last verified
- 28 Aug 2026
- First submitted
- 28 May 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
- ClinicalTrials.gov ID
- NCT06995885
- Acronym / sponsor ID
- 10002297
- Conditions
- Substance Use Disorders (SUDs)
- Keywords
- People who use opioids (PWUOs), Opioids, Timeline Follow-Back (TLFB)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 May 2025 (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.
Background:
A Timeline Follow-Back (TLFB) is a tool that helps researchers track how much of a substance a person uses. Different versions of the tool are used to track the use of alcohol, cigarettes, and cannabis. But there is no TLFB to track a person s use of nonmedical opioids. (These are opioids not obtained from a medical source; they may also be called "street" opioids.) Researchers are creating an Opioid TLFB (OpiTLFB) that asks better questions and records more useful answers to identify what kinds of nonmedical opioids people are using.
Objective:
To test a new research tool to track a person's use of nonmedical opioids.
Eligibility:
People aged 18 years or older who currently use opioids nonmedically at least once a week.
Design:
Participants will have 1 study visit at a clinic in Baltimore, Maryland. The visit will take 1 to 4 hours.
Participants will sit at a computer with a researcher and fill out a calendar. They will record their use of opioids each day for the past 30 days. They will be asked what the drugs were called and what they looked like. This task might take 30 minutes.
Participants will be interviewed. The researcher will ask about their experiences getting opioids from friends, dealers, or other sources; how the experience of getting opioids has changed over time; and about any changes they have noticed across different areas of Baltimore. Researchers will ask how the OpiTLFB could be easier to fill out and how it could provide more useful information. This task might take 30 minutes.
Participants will provide a urine sample.
Detailed description
Study Description:
Observational, on-site study for the purpose of instrument development. Currently used assessments of recent opioid use do not reflect the current market for street opioids. This protocol will use semistructured interviews (supplemented with results from comprehensive toxicology of approximately 1,200 analytes in urine) to develop a workable typology of the current street-opioid market in the Baltimore region, and a TLFB calendar that asks germane questions and offers usable response options for products and amounts.
Objectives:
- To conduct semistructured interviews with people who use opioids (PWUOs) in the Baltimore area about their recent opioid use, for development of a TLFB instrument that assesses use in terms that accord with the current conditions of the market.
- To perform comprehensive toxicology testing so that an appearancedriven and effect-driven typology of street opioids can be tentatively mapped onto their likely contents.
Endpoints:
- At least three consecutive respondents (after an initial minimum of 25 respondents) for whom the OpiTLFB needs no further modification to capture their pattern of opioid use.
- Associations between OpiTLFB indices (name, physical appearance, and effects of product) and urine-toxicology results.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People who use opioids (PWUOs) | – | –Current use of an opioid obtained in a nonmedical context (i.e., not from a pharmacy or in a healthcare setting), at least weekly |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We may enroll participants in this protocol from the pool that screens for other protocols at the NIDA IRP. We may also advertise for this protocol directly. If we decide to launch an ad campaign for this specific protocol, we will primarily recruit in the Baltimore metro area. We may also recontact previous participants from NIDA IRP studies who have expressed interest in participating in future NIDA studies and agreed to such recontact. Additionally, study team members attend events hosted by the Office of the Clinical Director to engage with local community partners. This includes clinics, treatment facilities, medical facilities, advocacy groups, and local businesses. We conduct outreach at community events/locations such as health expos, festivals, and other local venues. During these events, we display and offer approved recruitment materials.
Key inclusion criteria (6 listed)
- To be eligible to participate in this study, an individual must meet the following criteria:
- Age 18 years or older
- Self-report of current use of opioids obtained in a nonmedical context (i.e., not from a pharmacy or in a healthcare setting), at least once a week.
- Able to understand and communicate in written and spoken English.
- Justification: Initial development of the OpiTLFB requires strong, unmediated communication between the study team and the participants. Further development and modification for non-English-speaking interviewees is best undertaken as a separate project when the OpiTLFB is ready for use.
Key exclusion criteria (1 listed)
- 1. Any medical, psychiatric, or social conditions that the investigators believe would make participation in this protocol not in the best interest of the participant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
At least three consecutive respondents (after an initial minimum of 25 respondents) for whom the OpiTLFB needs no further modification to capture their pattern of opioid use.
Time frame: 6-24 months
Existing TLFB measures assess opioid use in terms that no longer match what PWUOs can actually obtain. This hampers both baseline characterization and quantification of opioid-use changes in study participants.
Associations between OpiTLFB indices (name, physical appearance, and effects of product) and urine-toxicology results.
Time frame: 6-24 months
This will help ensure that our typology of street opioids reflects real and consistent differences in product composition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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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.
David H Epstein, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Substance Use Disorders (SUDs), run by National Institute on Drug Abuse (NIDA) 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 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: enrolling by invitation, as of the sponsor's last update on 28 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
At least three consecutive respondents (after an initial minimum of 25 respondents) for whom the OpiTLFB needs no further modification to capture their pattern of opioid use. (time frame: 6-24 months). 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 28 Oct 2026.