Actively Recruiting
Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
Led by Rutgers, The State University of New Jersey · Updated on 2025-08-08
224
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
Rutgers, The State University of New Jersey
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying opioid use disorder (OUD) in individuals maintained on buprenorphine (BUP) to evaluate the effects of guanfacine extended release (GXR) and Mindfulness Oriented Recovery Enhancement (MORE), alone and combined. The study aims to understand how these treatments may reduce opioid craving and improve emotional regulation during stress and opioid cue exposure, addressing the limitations of current medication-assisted treatments in preventing relapse and improving adherence. Participants will be randomly assigned to one of four groups in a 2x2 design: GXR with MORE, GXR with a support group control, placebo with MORE, or placebo with support group control. The GXR dose is 3 mg daily for six weeks. The behavioral intervention MORE is provided weekly during this period. A pre- and post-intervention laboratory study will expose participants to personalized guided imageries (stress, opioid cue, neutral) to assess responses. A subsequent phase involving MRI scans will explore neural mechanisms. During the study, participants will undergo assessments including measures of opioid craving, anxiety, mood, stress, emotional dysregulation, heart rate, brain activation, and connectivity before and after imagery exposure. Safety and health status will be monitored, and the total intervention lasts six weeks. The study evaluates the combined medication and behavioral therapy effects on both behavioral and neural outcomes to better understand and improve treatments for OUD.
CONDITIONS
Brief Title
Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 to 55 years with a body mass index (BMI) of 18-35
- Diagnosed with opioid use disorder by SCID-5
- Maintained on buprenorphine for at least 4 weeks
- Positive urine toxicology screen for non-prescription opioids
- In good health as verified by screening exam
- Able to read English and provide informed consent
You will not qualify if you...
- Current moderate to severe substance use disorder other than opioids or nicotine (mild use allowed)
- Use of medications affecting brain function in last 6 months except buprenorphine and stable SSRIs
- Psychotic or severely psychiatrically disabled (e.g., suicidal, current mania)
- Hypotension with sitting blood pressure below 100/50 mmHg
- Pregnant, nursing women, or those refusing reliable birth control
- Clinically significant heart conduction abnormalities on EKG at baseline (QTc >450 msec men, >470 msec women)
- Failure to meet fMRI safety protocols (for R33 phase participants)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive Guanfacine pharmacotherapy and/or Mindfulness Oriented Recovery Enhancement (MORE) behavioral intervention alongside buprenorphine maintenance.
Weekly visits for up to 6 weeks
Trial Site Locations
Total: 1 location
1
Rutgers School of Health Professions
Newark, New Jersey, United States, 07107
Actively Recruiting
Research Team
S
Suchismita Ray, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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