N/A
N=300
Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments
Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02586896 ↗Enrolled (actual)
300
Serious AEs
8.3%
Results posted
Mar 2020
Primary outcome: Primary: Initiation of Treatment for Opioid Dependence — 85; 74; 63; 75 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Strengths-based Case Management (SBCM) (Behavioral); Screening, Assessment, and Referral (SAR) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Initiation of Treatment for Opioid Dependence |
85; 74; 63; 75 | — |
| PRIMARY Engagement in Treatment for Opioid Dependence |
21.77; 17.72 | 0.29 |
| SECONDARY Number of Participants With Successful Outcome for Opioid Use |
41; 28; 107; 121 | — |
| SECONDARY Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire |
11.23; 11.22 | 0.91 |
| SECONDARY Initiation in Participants With Higher Levels of Environmental Instability at Baseline |
62.5; 57.8 | 0.09 |
| SECONDARY Engagement in Participants With Higher Levels of Environmental Instability at Baseline |
22.16; 19.89 | 0.54 |
Summary
This study will compare the effects of brief strengths-based case management (SBCM) to the effects of screening, assessment and referral alone (SAR) in opioid-dependent patients. Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per group) to receive 1) up to 6 sessions of SBCM; or 2) SAR. Follow-up assessments will be completed at 3 and 6 months, by staff who are blinded to treatment condition.
Eligibility Criteria
Inclusion Criteria
- Registration as patient in the ED during study screening hours;
- Endorsement of three or more opioid dependence criteria on the DSM-IV checklist
- Age 18 years or older;
- Adequate English proficiency;
- Ability to provide informed consent;
- Self-report use of opioids in the last 30 days
Exclusion Criteria
- Inability to participate due to emergency treatment;
- Significant impairment of cognition or judgment rendering the person incapable of informed consent. (e.g., traumatic brain injury, delirium, intoxication);
- Status as a prisoner or in police custody at the time of treatment;
- Current engagement in substance use disorder treatment;
- Residence more than 50 miles from the location of follow-up visits;
- Inability to provide sufficient contact information (must provide at least 2 reliable locators);
- Unavailable for follow-up (e.g., planning to relocate within 6 months)
- Prior participation in the current study.
- Current participation in a research study related to substance use.
Data sourced from ClinicalTrials.gov (NCT02586896). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.