Guanfacine plus mindfulness to support buprenorphine treatment for opioid use disorder.

Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder

This trial will test whether adding the medication guanfacine and a mindfulness program to buprenorphine helps adults with opioid use disorder reduce cravings and stay in treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Rutgers, The State University of New Jersey (Academic / other)
• Locations: 1 site (Newark, New Jersey)
• Trial ID: NCT06642181 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study combines the alpha-2 agonist guanfacine with a structured mindfulness program (Mindfulness Oriented Recovery Enhancement, MORE) as adjuncts to ongoing buprenorphine maintenance. Planned enrollment is 224 participants across initial and expansion phases who are adults aged 18–55 and have been stabilized on buprenorphine for at least four weeks. Participants will receive guanfacine pharmacotherapy and group-based MORE sessions at Rutgers in Newark, NJ, with regular clinic visits to monitor craving provoked by stress and opioid cues, urine toxicology, adherence, and safety measures such as blood pressure and EKG. The trial aims to see if the combined medication and behavioral approach reduces relapse risk and improves emotional and reward regulation compared with standard buprenorphine care.

Who should consider this trial

Good fit: Adults aged 18–55 with DSM-5 opioid use disorder who have been maintained on buprenorphine for at least four weeks, have BMI 18–35, a positive urine toxicology for non-prescription opioids, and can read English and provide informed consent are ideal candidates.

Not a fit: People with moderate to severe non-opioid substance use disorders (except nicotine), serious psychiatric instability (e.g., current mania or active suicidality), hypotension, pregnancy or nursing, or recent use of medications that affect cerebral function are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, this combined pharmacologic and mindfulness approach could reduce stress- and cue-triggered opioid craving and lower relapse rates for people on buprenorphine.

How similar studies have performed: Prior studies indicate guanfacine can reduce stress-provoked craving and mindfulness-based interventions like MORE can reduce cue-provoked craving, but combining both as adjuncts to buprenorphine is a novel approach with limited prior testing.

Eligibility criteria

Inclusion Criteria:

N=224 individuals with a history of SCID-5 OUD, and maintained on BUP for at least 4 weeks (N=80 in the R61 phase and N=144 in the R33 phase). These individuals must be:

* aged 18 to 55 years and have a body mass index (BMI) of 18-35;
* have a positive urine toxicology screen for non-prescription opioids
* be in good health as verified by screening examination
* able to read English and provide informed consent.

Exclusion Criteria:

* Current SCID V criteria for a moderate to severe substance use disorder other than opioids or nicotine (although mild use will be permitted)
* Use of medications in the last 6 months that may affect cerebral function with the exception of BUP and individuals stabilized on SSRIs
* psychotic or severely psychiatrically disabled (i.e. suicidal, current mania)
* hypotensive individuals with sitting blood pressure below 100/50 mmHG
* Women who are pregnant, nursing or refuse to use a reliable form of birth control
* EKG evidence at baseline screening of any clinically significant conduction abnormalities (Bazett's QTc of \>450 msec for men and QTc\>470 msec for women)
* R33 phase will additionally include failure to satisfy fMRI safety protocols.

Where this trial is running

Newark, New Jersey

• Rutgers School of Health Professions — Newark, New Jersey, United States (Recruiting)

Study contacts

• Study coordinator: Suchismita Ray, PhD

Conditions Mindfulness; Guanfacine; Opioid Use Disorder; Opioid; MIndfulness