Guanfacine + Mindfulness for Opioid Use Disorder
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.
Do I need to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you must be on buprenorphine (BUP) for at least 4 weeks and can be stabilized on SSRIs. Other medications affecting brain function should not have been used in the last 6 months.
What data supports the effectiveness of the treatment Guanfacine + Mindfulness for Opioid Use Disorder?
Research shows that Mindfulness-Oriented Recovery Enhancement (MORE) can help people with opioid use disorder by reducing drug use and improving emotional well-being. MORE combines mindfulness, cognitive-behavioral therapy, and positive psychology, and has been effective in addressing both addiction and chronic pain.12345
Is the combination of Guanfacine and Mindfulness-Oriented Recovery Enhancement (MORE) safe for humans?
The available research on Mindfulness-Oriented Recovery Enhancement (MORE) suggests it is a safe intervention for individuals with opioid use disorder, as it has been tested in various studies without reported safety concerns. However, there is no specific safety data available for the combination of Guanfacine and MORE.12345
How does the treatment Guanfacine + Mindfulness for Opioid Use Disorder differ from other treatments?
This treatment is unique because it combines guanfacine, a medication that has been studied for its potential to aid in opioid withdrawal, with Mindfulness-Oriented Recovery Enhancement (MORE), a behavioral therapy that integrates mindfulness, cognitive-behavioral therapy, and positive psychology to address both opioid use and chronic pain. This dual approach aims to tackle both the physical and psychological aspects of opioid use disorder, which is not commonly addressed by standard treatments.13456
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Guanfacine extended release or placebo, combined with either Mindfulness Oriented Recovery Enhancement or a Support Group control for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Neuroimaging Study
Participants undergo fMRI scans to assess brain activation and connectivity during exposure to stress, opioid, and neutral scripts
Treatment Details
Interventions
- Guanfacine
- Mindfulness Oriented Recovery Enhancement (MORE)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator