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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-09-30

Brief Summary

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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, mood, stress, emotional reappraisal, and heart rate will be collected before and after imagery exposure. Following milestone completion, an identical design is proposed in N=144 individuals, where participants will be exposed to imageries in the MRI scanner (R33). On the basis of prior research, it is hypothesized in that GXR will attenuate opioid craving and improve emotion regulation during stress, while MORE will demonstrate the same effects during opioid cue exposure. Combined GXR and MORE will also demonstrate additive or synergistic improvements compared with each intervention alone (R61). The effects of GXR on opioid cue- and MORE on stress-provoked opioid seeking will be explored. In the R33 component, it is hypothesized that GXR will improve regulatory and affective brain function during stress, and MORE will improve regulatory and reward function during opioid cue exposure. Combined GXR and MORE may improve regulatory function in an additive or synergistic manner (R33). Findings will help elucidate the efficacy and neural mechanisms underpinning a novel integrated pharmaco-behavioral therapy for OUD individuals maintained on BUP.

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Detailed Description

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Conditions

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Mindfulness Guanfacine Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Combined Group

Will receive both Guanfacine pharmacotherapy and MORE intervention

Group Type EXPERIMENTAL

Guanfacine pharmacotherapy

Intervention Type DRUG

It is a pharmacotherapy

Mindfulness Oriented Recovery Enhancement (MORE)

Intervention Type BEHAVIORAL

It is a mindfulness intervention

MORE Group

Will receive MORE intervention and placebo medication

Group Type EXPERIMENTAL

Mindfulness Oriented Recovery Enhancement (MORE)

Intervention Type BEHAVIORAL

It is a mindfulness intervention

Guanfacine Group

Will receive Guanfacine intervention and Support group control (non-mindfulness) intervention

Group Type EXPERIMENTAL

Guanfacine pharmacotherapy

Intervention Type DRUG

It is a pharmacotherapy

Control Group

Will receive placebo and support group control (non-mindfulness)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guanfacine pharmacotherapy

It is a pharmacotherapy

Intervention Type DRUG

Mindfulness Oriented Recovery Enhancement (MORE)

It is a mindfulness intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No