Clinical trial NCT02586896: Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments
Official title: Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Dependence
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Wright State University
First posted: 2015-10-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: As addiction treatment becomes increasingly integrated into the medical care system, two models have rightly received a great deal of attention. The first is the use of Screening, Brief Intervention, and Referral to Treatment (SBIRT) models to identify cases, provide therapeutic contact, and refer the more severe cases to longer-term care. The second is the treatment of addictions using medical models of treatment, including those that can be implemented in primary care settings. Much less attention has been paid to optimizing strategies for bridging the gap between SBIRT and more intensive/longer-term treatment for those on the severe end of the spectrum. This factor is of critical importance for opioid dependent patients, whose needs are not met by brief interventions or brief treatment. Emergency room interventions for substance use disorders have been largely limited to brief interventions/SBIRT models, and these have focused primarily on alcohol. Although there is a substantial literature documenting the value of case management in linking drug users to treatment, this approach has not been applied to drug users in the emergency department (ED) setting.

In a sample of opioid dependent patients seen in a medical ED who are not currently engaged in treatment, this study will compare the effects of brief strengths-based case management (SBCM) to the effects of screening, assessment and referral alone. Participants meeting DSM-IV criteria for opioid dependence will be randomly assigned (150 per group) to receive 1) Screening, Assessment and Referral or 2) up to 6 sessions of SBCM based on the model previously implemented by Rapp and colleagues in prior studies. Staff who are blinded to treatment condition will complete follow-up assessments at 3 and 6 months. Aims of the study are to identify the main effects of SBCM on substance abuse treatment initiation and engagement, use of opioids and other drugs, and broader measures of health and life functioning; to examine the interactions between treatment assignment and selected participant attributes in predicting treatment initiation, engagement, and substance use outcomes; and to examine effects of treatment involvement on substance use outcomes in the two treatment groups.

The proposed study will be the first trial using a case management approach to link drug dependent patients presenting in EDs to longer-term addiction treatment. It will be one of the first trials focusing specifically on opioid dependent patients in medical EDs. A further innovative feature is that the case management approach will emphasize linkage to pharmacotherapy, facilitating linkage to office-based buprenorphine, methadone, or naltrexone for patients who desire this treatment.

Eligibility criteria: Inclusion Criteria:

1. Registration as patient in the ED during study screening hours;
2. Endorsement of three or more opioid dependence criteria on the DSM-IV checklist
3. Age 18 years or older;
4. Adequate English proficiency;
5. Ability to provide informed consent;
6. Self-report use of opioids in the last 30 days

Exclusion Criteria:

1. Inability to participate due to emergency treatment;
2. Significant impairment of cognition or judgment rendering the person incapable of informed consent. (e.g., traumatic brain injury, delirium, intoxication);
3. Status as a prisoner or in police custody at the time of treatment;
4. Current engagement in substance use disorder treatment;
5. Residence more than 50 miles from the location of follow-up visits;
6. Inability to provide sufficient contact information (must provide at least 2 reliable locators);
7. Unavailable for follow-up (e.g., planning to relocate within 6 months)
8. Prior participation in the current study.
9. Current participation in a research study related to substance use.

Primary outcomes:
measure: Initiation of Treatment for Opioid Dependence
timeFrame: 3 months
measure: Engagement in Treatment for Opioid Dependence
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants With Successful Outcome for Opioid Use
timeFrame: 3 months
measure: Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire
timeFrame: 3 months
measure: Initiation in Participants With Higher Levels of Environmental Instability at Baseline
timeFrame: 3 months
measure: Engagement in Participants With Higher Levels of Environmental Instability at Baseline
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Michael P Bogenschutz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Regis A, Meyers-Ohki SE, Mennenga SE, Greco PP, Glisker R, Kolaric R, McCormack RP, Rapp RC, Bogenschutz MP. Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial. Trials. 2020 Sep 3;21(1):761. doi: 10.1186/s13063-020-04684-6.