Developing a Clinical Outcome Assessment for Opioid Craving (NCT05109429) | Clinical Trial Compass
CompletedNot Applicable
Developing a Clinical Outcome Assessment for Opioid Craving
United States74 participantsStarted 2022-03-03
Plain-language summary
The purpose of this study is to collect information about opioid craving so that the investigators can develop an opioid craving assessment to improve treatments for individuals with opioid use disorder. To collect this information, the investigators are recruiting individuals in treatment for opioid use disorder who will complete cue-induced opioid craving tasks where these individuals will: (1) look at pictures of neutral objects and touch neutral objects (e.g., water bottles or flashlights), (2) look at opioid-related images, and (3) look and touch opioid-related objects. Participants will then complete a one-on-one interview about the thoughts, feelings and physical sensations the participants experienced during the cue-induced craving session. Participants will also complete questionnaires and existing opioid craving assessments. Finally, participants will provide formal feedback about existing opioid craving assessments with cognitive interviews.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age and older
* Opioid-positive urine sample at admission visit (excluding individuals receiving Naltrexone).
* Current opioid use disorder per Diagnostic Statistical Manual (DSM)-5
* Currently in treatment for opioid use disorder
Exclusion Criteria:
* Being pregnant or breastfeeding, or may become pregnant during the trial
* History of psychosis or mania or other serious psychiatric disorders assessed by the Mini International Neuropsychiatric Interview
* Past 30-day suicidal behavior assessed by the Columbia Suicide Severity Rating Scale
* Have circumstances that would interfere with study participation (e.g., impending jail).
* Positive for illicit substances except opioids and cannabis
* Current substance use disorder other than opioid or nicotine
* Current intoxication
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Craving Domains
Timeframe: Sessions 1, 2, and 3 after the cue-induced craving task (approximately 1 hour into session)
2
Change in Acceptability of Craving Assessments
Timeframe: Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)
3
Change in Deficits in Craving Assessments
Timeframe: Sessions 1, 2, and 3 after cue-induced craving task (approximately 1 hour into session)