By InvitationNot Applicable

Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl

United States30 participantsStarted 2026-07-02

Plain-language 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. (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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.
. Ability of subject to understand and the willingness to sign a written informed consent document.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study seems focused on developing and refining a new interview tool for tracking opioid use — called the OpiTLFB — rather than testing a treatment. Can you help me understand what actually happens during participation, and whether it involves any changes to my current care or medications?
2Since this trial is listed as 'enrolling by invitation only,' can you tell me whether I'm being considered for it, and what criteria are being used to decide who gets invited?
3The study is comparing what people report about their opioid use — like the name, appearance, and effects of what they used — against urine toxicology results. Does that mean my urine test results would be collected and analyzed as part of the research, and how would that information be stored or shared?
4This appears to be a research methods study with no assigned phase, meaning it's not testing a new drug or therapy. Would participating in this study affect my access to standard addiction treatment, or could I still pursue other treatment options at the same time?
5Since the goal is to build a better tool for tracking fentanyl-era opioid use patterns, what, if any, direct benefit might I personally get from taking part — or is this primarily aimed at helping future patients and researchers?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: 6-24 months

Associations between OpiTLFB indices (name, physical appearance, and effects of product) and urine-toxicology results.

Timeframe: 6-24 months

Trial details

NCT IDNCT06995885

SponsorNational Institute on Drug Abuse (NIDA)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2027-05-31

View on ClinicalTrials.gov More Substance Use Disorders (SUDs) trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.
. Ability of subject to understand and the willingness to sign a written informed consent document.

What they're measuring

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.

Timeframe: 6-24 months

Associations between OpiTLFB indices (name, physical appearance, and effects of product) and urine-toxicology results.

Timeframe: 6-24 months