Guanfacine + Mindfulness for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with Opioid Use Disorder who are currently on buprenorphine maintenance. It's designed to help those who struggle with emotional control and reward sensitivity when faced with stress or opioid-related cues.

Inclusion Criteria

I have been on BUP for opioid use disorder for at least 4 weeks.

Positive urine toxicology screen for non-prescription opioids

Able to read English and provide informed consent

+2 more

Exclusion Criteria

R33 phase will additionally include failure to satisfy fMRI safety protocols

Current SCID V criteria for a moderate to severe substance use disorder other than opioids or nicotine (mild use permitted)

Psychotic or severely psychiatrically disabled (i.e. suicidal, current mania)

+4 more

Participant Groups

The study tests whether Guanfacine, a medication, combined with Mindfulness Oriented Recovery Enhancement (MORE), a behavioral therapy, can improve long-term outcomes in opioid addiction better than either approach alone.

4Treatment groups

Experimental Treatment

Active Control

Group I: MORE GroupExperimental Treatment1 Intervention

Will receive MORE intervention and placebo medication

Group II: Guanfacine GroupExperimental Treatment1 Intervention

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

Group III: Combined GroupExperimental Treatment2 Interventions

Will receive both Guanfacine pharmacotherapy and MORE intervention

Group IV: Control GroupActive Control1 Intervention

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