Clinical Trial

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

Enrolling by Invitation
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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.
Protocol Amendment History 265 amendments
This ClinicalTrials.gov record has been amended 265 times since 2025-05-28; most recent amendment 2026-07-24.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-10-01
Trial Details
NCT Number NCT06995885
Lead Sponsor National Institute on Drug Abuse (NIDA)
Conditions Substance Use Disorders (SUDs)
Enrollment 30 participants
Start Date 2026-08-19
Primary Completion 2027-05-31 (estimated)
Study Completion 2027-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-14