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Guanfacine and Mindfulness for Opioid Use Disorder

This study is exploring if combining Guanfacine (a medication) and Mindfulness Oriented Recovery Enhancement (MORE, a behavioral therapy) can help people with Opioid Use Disorder (OUD) who are already taking buprenorphine. Researchers want to see if these additions can better reduce cravings, anxiety, and stress, which are often linked to relapse. You might be able to join if you are 18-55 years old, have OUD, are on buprenorphine, and meet other health criteria. The study aims to enroll 224 participants. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 224 participants. It is testing Guanfacine pharmacotherapy and Mindfulness Oriented Recovery Enhancement (MORE) behavioral intervention.
What's involved
The primary endpoints for this study, such as craving, anxiety, and stress, are measured at pre- and post-intervention, which is after 6 weeks of intervention.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at pre- and post-intervention (6 weeks intervention).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06642181

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Rutgers, The State University of New Jersey
~224 participants
Updated 2025-08-08 on ClinicalTrials.gov
What's tested:Guanfacine pharmacotherapyMindfulness Oriented Recovery Enhancement (MORE)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Craving
Measured over At pre- and post-intervention (6 weeks intervention)
+7 more outcomes measured

Conditions

Mindfulness
Guanfacine
Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Suchismita Ray, PhD
[email protected]
732-266-4553
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • CravingAt pre- and post-intervention (6 weeks intervention)

    Self report of opioid craving will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme).

  • AnxietyAt pre- and post-intervention (6 weeks intervention)

    Self report of anxiety will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme). .

  • StressAt pre- and post-intervention (6 weeks intervention)

    Self report of stress will be collected. Will be measured using a likert scale 0 (not at all) to 10 (extreme).

  • MoodAt pre- and post-intervention (6 weeks intervention)

    Self report of mood will be collected. Positive and negative mood will be collected on a 4 point likert scale 0 (not at all) and 4 (extreme)

  • Emotional DysregulationAt pre- and post-intervention (6 weeks intervention)

    Self report of emotional dysregulation data will be collected. Will be measured using a 10 point likert scale (0=not at all) and 10 (extreme)

  • Heart RateAt pre- and post-intervention (6 weeks intervention)

    Heart rate data will be collected using an EKG monitor during the entire lab procedure while the participants will hear stress, opioid, and neutral related scripts.

  • Brain ActivationAt pre- and post-intervention (6 weeks intervention)

    Brain activation data will be collected using Blood Oxygen Level Dependent (BOLD) signal during functional magnetic resonance imaging (fMRI) while participants hear stress, opioid and neutral scripts.

  • Brain ConnectivityAt pre- and post-intervention (6 weeks intervention)

    Brain connectivity data will be collected using Blood Oxygen Level Dependent (BOLD) signal during functional magnetic resonance imaging (fMRI) while participants hear stress, opioid and neutral scripts.