Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments

Opioid Dependence Clinical Trial

Official title:

Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586896
• Other study ID #: 15-00862
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: April 23, 2019

Study information

• Verified date: April 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 23, 2019
• Est. primary completion date: April 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Opioid Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• Strengths-based Case Management (SBCM)
The six case management sessions for the proposed trial are based on those described in manuals developed by Dr. Rapp for two clinical trials, one supported by National Institute on Drug Abuse (NIDA) and another by the Centers for Disease Control (CDC). Each session is guided by specific objectives that promote linkage with and retention in substance abuse treatment, particularly pharmacotherapy for opioid dependence in a specialty or primary care setting. Objectives from the earlier trials will be adapted to fit the specific context of this trial, linking with and staying in treatment following an emergency department visit. Initiation of the relationship between client and case manager begins immediately following random assignment and termination takes place when either (1) six sessions have occurred; (2) ninety days have elapsed; or (3) clients discontinue involvement.
• Screening, Assessment, and Referral (SAR)
The research assistant will provide these participants with an information sheet listing treatment (including both specialty treatment centers and primary care clinics that provide buprenorphine) and self-help resources in their community. The referral sheet includes names, addresses, and phone numbers of local addiction treatment agencies. Because the emergency department does not currently screen or refer systematically, the SAR condition represents a level of care significantly higher than "treatment as usual." Participants will also receive an informational pamphlet about drug use and its consequences, addiction, and treatment.

Locations

Country	Name	City	State
United States	Bellevue Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of Treatment for Opioid Dependence	"Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D.	3 months
Primary	Engagement in Treatment for Opioid Dependence	Using the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records.	3 months
Secondary	Number of Participants With Successful Outcome for Opioid Use	"Successful outcome" will be defined as 1) 3-month urine negative for opioids (opiates, oxycodone, methadone, buprenorphine, or propoxyphene) unless prescribed for opioid dependence, and 2) no more than two days of self-reported opioid use on the Form 90-D in the 4 weeks (30 days) prior to the 3-month evaluation.	3 months
Secondary	Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire	The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. Participants express how much they have experienced the items in the preceding 2 weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). Raw domain score is the sum of respective item scores. All domain scores are reported between 4 and 20.	3 months
Secondary	Initiation in Participants With Higher Levels of Environmental Instability at Baseline	"Initiation" is defined as a dichotomous outcome (yes/no), and is considered to have occurred if patients report any substance abuse counseling sessions (excluding SBCM) from the time of the baseline assessment up to the day before the three-month interview, as captured via self-report on the Form 90-D.	3 months
Secondary	Engagement in Participants With Higher Levels of Environmental Instability at Baseline	Using the same timeframe as "initiation," "engagement" is defined as the number days of medication use for opioid dependence, based on Form 90-D self-report verified by clinic dosing logs and Prescription Drug Monitoring Program records.	3 months