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

RecruitingPhase 1Ages 18 Years - 55 YearsAllRutgers, The State University of New Jersey
NCT06642181 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The US is currently going through an opioid crisis, and while Medication Assisted Treatments such as buprenorphine (BUP) have proved highly effective at stabilizing the neurobiology underlying acute withdrawal, they have been less effective at preventing longer-term relapse and adherence. This may be due to the fact that they do not fully engage the neural processes sub-serving the emotional control of sensitized negative mood and reward sensitivity during stress- and opioid-cue provocation, respectively. In contrast while the alpha2 agonist, guanfacine, may attenuate stress-provoked opioid craving by mediating top-down prefrontal control over sensitized dysphoria, the behavioral intervention, Mindfulness Oriented Recovery Enhancement (MORE) may reduce opioid cue-provoked craving by mediating top-down prefrontal control over hedonic dysregulation. Furthermore, while both interventions se

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📋 Eligibility rules (as published)
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.
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What it tests

  • Guanfacine pharmacotherapy
  • Mindfulness Oriented Recovery Enhancement (MORE)
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Where

1 site
Rutgers School of Health Professions
Newark, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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