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NCT06642181 · ClinicalTrials.gov registry record · Phase 1
Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
A Phase 1 study of Opioid Use Disorder and Mindfulness, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 224
- Enrollment target
- 1
- Study location
NCT06642181 is a Phase 1 study of Opioid Use Disorder and Mindfulness that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 224 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06642181, a Phase 1 study of Opioid Use Disorder and Mindfulness, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 224 participants
- Enrollment target
- 1
- Study location
Study Summary
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 separately may prove effective as longer-term adjunctive therapies, they may offer greater efficacy together, providing a unique medication/behavioral combination able to target both stress and reward provocation mechanisms. To optimally test this hypothesis, a staged approach is proposed to first confirm the efficacy of both GXR and MORE, independently and combined (R61), prior to elucidating underlying neural mechanisms (R33). Using a 2 X 2 design, N=80 OUD individuals on BUP will be randomized to either 6-weeks of Guanfacine extended release (GXR; 3mgs, n=40) or placebo (PBO; n=40). Half of all participants in each group will then receive either weekly MORE, or a Support Group (SG) control, creating four intervention groups (Control Grp: PBO+SG, n=20); (GXR Grp: GXR+SG, n=20); (MORE Grp: PBO+ MORE, n=20); (Combined Grp: GXR+MORE, n=20). A pre- and post-laboratory study will be conducted before and after six weeks of intervention where participants will be randomly exposed to 3 personalized guided imageries (stress, opioid cue, neutral). Subjective measures of opioid craving, anxiety
Conditions Studied
Interventions
- DRUG Guanfacine pharmacotherapy
- BEHAVIORAL Mindfulness Oriented Recovery Enhancement (MORE)
Study Locations (1)
New Jersey
- Rutgers School of Health Professions - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2025-07-15 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06642181
The ClinicalTrials.gov registry entry for NCT06642181 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Guanfacine pharmacotherapy is the first listed.
NCT06642181 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT06642181 about?
NCT06642181 is a clinical study titled "Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder". 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 b...
What is the current status of trial NCT06642181?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 224 participants. The study started on 2025-07-15. Estimated completion is 2026-09-30.
What conditions does trial NCT06642181 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Mindfulness, Guanfacine.
What interventions are being tested in trial NCT06642181?
The interventions under investigation include: Guanfacine pharmacotherapy (DRUG), Mindfulness Oriented Recovery Enhancement (MORE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06642181?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06642181 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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