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Guanfacine + Mindfulness for Opioid Use Disorder
Phase 1
Waitlist Available
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 to 55 years with a body mass index (BMI) of 18-35
Be between 18 and 65 years old
Must not have
Women who are pregnant, nursing, or refuse to use a reliable form of birth control
Hypotensive individuals with sitting blood pressure below 100/50 mmHG
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre- and post-intervention (6 weeks intervention)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study the effectiveness of combining the medication guanfacine (GXR) and a behavioral intervention called Mindfulness Oriented Recovery Enhancement (MORE) in treating opioid use disorder (O
Who is the study for?
This trial is for individuals with Opioid Use Disorder who are currently on buprenorphine maintenance. It's designed to help those who struggle with emotional control and reward sensitivity when faced with stress or opioid-related cues.
What is being tested?
The study tests whether Guanfacine, a medication, combined with Mindfulness Oriented Recovery Enhancement (MORE), a behavioral therapy, can improve long-term outcomes in opioid addiction better than either approach alone.
What are the potential side effects?
Guanfacine may cause side effects like drowsiness, low blood pressure, dry mouth, and constipation. Mindfulness practice is generally safe but can sometimes bring up uncomfortable emotions or memories.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 55 years old with a BMI between 18 and 35.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, nursing, and agree to use birth control.
Select...
My sitting blood pressure is below 100/50 mmHg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at pre- and post-intervention (6 weeks intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre- and post-intervention (6 weeks intervention)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety
Brain Activation
Brain Connectivity
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: MORE GroupExperimental Treatment1 Intervention
Will receive MORE intervention and placebo medication
Group II: Guanfacine GroupExperimental Treatment1 Intervention
Will receive Guanfacine intervention and Support group control (non-mindfulness) intervention
Group III: Combined GroupExperimental Treatment2 Interventions
Will receive both Guanfacine pharmacotherapy and MORE intervention
Group IV: Control GroupActive Control1 Intervention
Will receive placebo and support group control (non-mindfulness)
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
452 Previous Clinical Trials
69,288 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,594 Previous Clinical Trials
3,328,512 Total Patients Enrolled