Protocol Details
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
This study is currently recruiting participants.
Summary
Number |
002297-DA |
Sponsoring Institute |
National Institute on Drug Abuse (NIDA) |
Recruitment Detail |
Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
Children;
Fetuses;
Neonates;
Non-English Speaking;
Pregnant Women |
Keywords |
People who use opioids (PWUOs);
Opioids;
Timeline Follow-Back (TLFB) |
Recruitment Keyword(s) |
None |
Condition(s) |
Substance use disorders (SUDs) |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute on Drug Abuse |
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.
Eligibility
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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT06995885