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

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Observational

Phase

Not applicable / not listed

Age range

18 years - 99 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

30 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

• INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet the following criteria:

1. Age 18 years or older
2. 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.
3. 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.
4. Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

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.

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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not reported

Masking

Not reported

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

National Institute on Drug Abuse (NIDA)

Study start

Nov 15, 2026 Estimated

Primary completion

May 31, 2027 Estimated

Study completion

May 31, 2027 Estimated

First posted

May 30, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.