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

NCT06995885 | Enrolling By Invitation

• 2 other identifiers: 10002297002297-DA
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 used a nonmedical opioid within the past 30 days. 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.

Conditions

Substance Use Disorders (SUDs)

Keywords

People who use opioids (PWUOs); Opioids; Timeline Follow-Back (TLFB)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6-24 months

Study Arms (1)

People who use opioids (PWUOs)

Past 30-day use of an opioid obtained in a nonmedical context (i.e., not from a pharmacy or in a healthcare setting)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• To be eligible to participate in this study, an individual must meet the following criteria:
• Age 18 years or older
• Past 30-day use of an opioid obtained in a nonmedical context (i.e., not from a pharmacy or in a healthcare setting)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• David H Epstein, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: May 30, 2025
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-03-26

Locations

US (1)