Creating a new assessment for opioid craving
Developing a Clinical Outcome Assessment for Opioid Craving
NA · Johns Hopkins University · NCT05109429
This study is testing a new way to measure cravings for opioids in people with opioid use disorder to improve their treatment options.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 81 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05109429 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a valid clinical outcome assessment for opioid craving to enhance treatment options for individuals with opioid use disorder. Participants in treatment will engage in cue-induced craving tasks involving both neutral and opioid-related stimuli, followed by interviews to capture their experiences and feelings during these tasks. The study will gather qualitative feedback on existing assessments to ensure the new tool meets FDA standards for content validity. A total of 81 participants will be involved in this rigorous assessment process across three outpatient laboratory sessions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are currently in treatment for opioid use disorder and have a positive opioid urine sample.
Not a fit: Patients who are pregnant, have serious psychiatric disorders, or are currently using substances other than opioids or cannabis may not benefit from this study.
Why it matters
Potential benefit: If successful, this assessment could lead to improved treatment strategies for managing opioid cravings, potentially reducing relapse rates.
How similar studies have performed: While there is a lack of universally accepted assessments for opioid craving, this approach is novel and aims to fill a significant gap in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Behavioral Pharmacology Research Unit — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Cecilia L Bergeria, PhD — Johns Hopkins University
- Study coordinator: Cecilia L Bergeria, PhD
- Email: cberge21@jhmi.edu
- Phone: 410-550-1979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Craving, Opioid Use Disorder, Measure Development