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Behavioural Intervention
Peer Support for Polysubstance Abuse (PRISM Trial)
N/A
Recruiting
Led By Sarah M Kattakuzhy, MD
Research Sponsored by University of Maryland, College Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from intake to six-month follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a peer-led intervention to help opioid use disorder patients in an underserved, rural area adhere to medication and reduce polysubstance use.
Who is the study for?
This trial is for adults over 18 with opioid use disorder and polysubstance use in a rural area, who have struggled to stick to their medication plan or haven't refilled their pharmacy prescription recently. It's not for those with untreated severe mental health issues or pregnant individuals.
What is being tested?
The study tests 'Peer Activate,' a peer-led program aiming to improve adherence to opioid addiction medications and reduce the use of multiple substances. Participants will either receive this new intervention or the usual treatment, and they'll be followed for twelve months.
What are the potential side effects?
Since 'Peer Activate' involves behavioral support rather than medication, side effects are minimal compared to drug treatments. However, participants may experience emotional discomfort when discussing substance use habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured over 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured over 12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Six-Month Polysubstance Use Self Report
Six-Month Polysubstance Use Urinalysis
Secondary study objectives
Intervention Fidelity
Intervention Session Attendance
Intervention Uptake
+4 moreOther study objectives
Overdose risk
Six-month Criminal and Legal Activities
Six-month Health-related Quality of Life
+15 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: Peer-Delivered Behavioral Activation ("Peer Activate")Experimental Treatment1 Intervention
Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.
Group II: Treatment As UsualActive Control1 Intervention
Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreOTHER
716 Previous Clinical Trials
380,934 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,606 Previous Clinical Trials
3,329,689 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,091 Previous Clinical Trials
1,154,566 Total Patients Enrolled
University of Maryland, College ParkLead Sponsor
159 Previous Clinical Trials
46,283 Total Patients Enrolled
Sarah M Kattakuzhy, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
Jessica F Magidson, PhDPrincipal InvestigatorUniversity of Maryland, College Park
5 Previous Clinical Trials
374 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am getting treatment for opioid use disorder through a telemedicine program.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Peer-Delivered Behavioral Activation ("Peer Activate")
- Group 2: Treatment As Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.