Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642181
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Combined Guanfacine and Mindfulness Meditation As an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combined Guanfacine and Mindfulness Meditation As an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 medicationbehavioral 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 N80 OUD individuals on BUP will be randomized to either 6-weeks of Guanfacine extended release GXR 3mgs n40 or placebo PBO n40 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 PBOSG n20 GXR Grp GXRSG n20 MORE Grp PBO MORE n20 Combined Grp GXRMORE n20 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 N144 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None