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Behavioural Intervention
Collaborative Care for Substance Use Disorders
N/A
Waitlist Available
Led By Jennifer McNeely, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Current polysubstance use, defined as self-reported use of two or more substances of concern in the past 30 days, at least one of which is required to be an opioid or stimulant. Substances of concern include opioids (illicit opioids, nonmedical use of prescription opioids), stimulants (cocaine, methamphetamine), alcohol (heavy drinking defined as more than 5 for men and 4 for women drinks on a single occasion), and benzodiazepines (nonmedical use). Nonmedical use includes using prescription medications more than prescribed, or that were not prescribed to the individual taking them.
Age 18 years or older.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 10-12
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a care intervention to reduce days of opioid, stimulant and heavy alcohol use in adults with SUD.
Who is the study for?
This trial is for adults with moderate to severe substance use disorders involving opioids, stimulants, or alcohol. Participants must be over 18, speak and understand the study language, and have used multiple substances in the past month. Primary care providers enrolled in the study can also join. Not eligible if they don't meet these criteria.
What is being tested?
The Co-Care trial tests a collaborative approach to treat polysubstance abuse in primary care settings. It includes addiction specialist consultations, nurse visits, health coaching sessions, educational materials for patients and support for primary care providers.
What are the potential side effects?
Since this trial focuses on non-pharmacological interventions like education and counseling rather than medications, specific side effects are not listed as it does not involve drug treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have used two or more substances, including opioids or stimulants, non-medically in the last month.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ months 10-12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 10-12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total days of use of opioids, stimulants, and alcohol heavy drinking
Secondary study objectives
AUD symptom score from the Modified World Mental Health Composite International Diagnostic Interview (CIDI) questionnaire
Average days of abstinence from any unhealthy use of opioids, stimulants, and alcohol
Generalized Anxiety Disorder (GAD-7) score
+17 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Co-CareExperimental Treatment4 Interventions
Patient participants with providers will receive primary care treatment plus the full Co-Care intervention which includes: Nurse Care Manager (NCM) visits, Addiction specialist consultations through NCM if indicated, and Health coaching sessions.
Group II: Enhanced Usual Care (EUC)Active Control2 Interventions
Patient participants with providers will receive primary care treatment as usual plus educational materials.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,435 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,579 Previous Clinical Trials
3,316,575 Total Patients Enrolled
Jennifer McNeely, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
292 Total Patients Enrolled
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