Developing a New Opioid Withdrawal Assessment

This study aims to create a new way to measure opioid withdrawal, which is essential for improving how we manage opioid use disorder. Currently, there isn't a standard, FDA-approved tool to do this. This project will involve talking to people who have experienced opioid withdrawal to understand their symptoms. You might be able to join if you are 18 or older, have been diagnosed with opioid use disorder in the past year, speak English, and have experienced opioid withdrawal at least once in the last 30 days. You cannot participate if you are pregnant, breastfeeding, or have cognitive impairment. The study will be successful if it helps create a reliable and standardized assessment for opioid withdrawal symptoms.

Study design
This is an observational study with 30 participants. It uses a within-subject design, meaning each participant will complete two sessions.
What's involved
Participants will complete two sessions, comparing their responses to withdrawal questions after experiencing naloxone-precipitated withdrawal and after spontaneous withdrawal. Cognitive interviews will be conducted within 8 hours of each observation period ending.
Compensation
Not stated in the trial record.
Follow-up
Participants will be offered referrals to aftercare prior to study discharge. The primary endpoint, cognitive interviews, is measured within 8 hours of completing the withdrawal experience.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07094672

Development of an Opioid Withdrawal Clinical Outcome Assessment

Not Yet Recruiting
Not specifiedAges 18+Observational
University of Maryland, Baltimore
~30 participants
Updated 2026-08-14 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cognitive interview
Measured over Within 8 hours of completing the withdrawal experience
Opioid Use Disorder
1 sites across 1 states
Maryland1

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Eligibility criteria

Inclusion

Past year opioid use disorder, determined by (a) enrollment in current treatment for opioid use disorder and/or (b) an opioid-positive saliva test.
Fluent in English
Has experience with opioid withdrawal at least once in the past 30 days

Exclusion

Unable to provide informed consent due to cognitive impairment
Being pregnant or breastfeeding
History of psychosis or mania as determined by the MINI
Exhibiting suicidal behavior in the past 30 days as determined by the C-SSRS
Circumstances that could interfere with study participation
Previously participated in affiliated Focus Group study
  • Cognitive interviewWithin 8 hours of completing the withdrawal experience

    The experience of withdrawal will be probed qualitatively using cognitive interviews to capture all possible symptoms that opioid withdrawal may elicit in an individual