Opioid DependenceNCT02586896
Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments
A study testing Strengths-based Case Management (SBCM) and Screening, Assessment, and Referral (SAR) in people with Opioid Dependence, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Strengths-based Case Management (SBCM) and Screening, Assessment, and Referral (SAR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 23 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Opioid Dependence
- Being tested
- Strengths-based Case Management (SBCM), Screening, Assessment, and Referral (SAR)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengths-based Case Management (SBCM)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Strengths-based Case Management (SBCM) | Experimental | The structure of SBCM follows the widely accepted functions of case management-assessment, planning, linking, monitoring and advocacy-and the theory-driven gestalt of the strengths perspective. Strengths-based principles include an emphasis on client strengths, teaching clients a method for setting and completing goals, and development of a strong working alliance. Receives: Behavioral: Strengths-based Case Management (SBCM) |
| Screening, Assessment and Referral (SAR) | Active comparator | Following randomization, participants in the SAR condition will be provided with minimal scripted feedback to let them know that their assessment indicates substance dependence, and given a recommendation to seek treatment. Receives: Behavioral: Screening, Assessment, and Referral (SAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startMar 2016
- Primary completion23 Apr 2019
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Wright State University
- Responsible party
- Sponsor
- Investigators
- Michael P Bogenschutz, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586896
- Sponsor's protocol ID
- 15-00862
- Status last verified
- Apr 2020
- First submitted
- 22 Oct 2015
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32883337
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Interventions for Opioid Dependent Patients Presenting in Medical Emergency Departments
- ClinicalTrials.gov ID
- NCT02586896
- Acronym / sponsor ID
- 15-00862
- Conditions
- Opioid Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Wright State University
- Study start
- Mar 2016 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 23 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengths-based Case Management (SBCM) | Experimental | Behavioral: Strengths-based Case Management (SBCM)The structure of SBCM follows the widely accepted functions of case management-assessment, planning, linking, monitoring and advocacy-and the theory-driven gestalt of the strengths perspective. Strengths-based principles include an emphasis on client strengths, teaching clients a method for setting and completing goals, and development of a strong working alliance. |
| Screening, Assessment and Referral (SAR) | Active comparator | Behavioral: Screening, Assessment, and Referral (SAR)Following randomization, participants in the SAR condition will be provided with minimal scripted feedback to let them know that their assessment indicates substance dependence, and given a recommendation to seek treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Strengths-based Case Management (SBCM) |
| 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. | Behavioural | Screening, Assessment and Referral (SAR) |
Primary outcome
Initiation of Treatment for Opioid Dependence
Time frame: 3 months
"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.
Engagement in Treatment for Opioid Dependence
Time frame: 3 months
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.
4 secondary outcomes
Number of Participants With Successful Outcome for Opioid Use
Time frame: 3 months
Score on World Health Organization Quality of Life (WHOQoL) Brief Questionnaire
Time frame: 3 months
Initiation in Participants With Higher Levels of Environmental Instability at Baseline
Time frame: 3 months
Engagement in Participants With Higher Levels of Environmental Instability at Baseline
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32883337Regis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Bogenschutz, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengths-based Case Management (SBCM) and Screening, Assessment, and Referral (SAR) in people with Opioid Dependence, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of Treatment for Opioid Dependence (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02586896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.