Enrolling by Invitation

NCT Number: NCT06995885

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

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.

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Key information

Conditions

Substance Use Disorders (SUDs) Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA:

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.

Exclusion criteria

Any medical, psychiatric, or social conditions that the investigators believe would make participation in this protocol not in the best interest of the participant.

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 30, 2025
Registry last updated: Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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