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

National Institutes of Health (NIH)

Status: Invitation-only

Conditions: Substance Use Disorders (SUDs)

Study type: Observational

Funder types: NIH

Identifiers

NCT06995885

002297-DA

10002297

Details and patient eligibility

About

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.

Full description

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:

1. 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.
2. 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:

1. 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.
2. Associations between OpiTLFB indices (name, physical appearance, and effects of product) and urine-toxicology results.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• INCLUSION CRITERIA:

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

1. Age 18 years or older

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

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.

Trial design

30 participants in 1 patient group

People who use opioids (PWUOs)

Description:

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