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

Launched by RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY · Oct 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how two different approaches—medication and mindfulness—can work together to help people with opioid use disorder who are already being treated with buprenorphine, a medication that helps reduce cravings and withdrawal symptoms. The researchers want to see if adding guanfacine, a medication that may help control stress and cravings, along with a mindfulness program called Mindfulness Oriented Recovery Enhancement (MORE), can improve the overall treatment results. The trial will involve 224 participants who are between 18 and 55 years old and have a history of opioid use disorder. They must also be in good health and able to understand English.

Participants in the trial will be divided into four groups to test different combinations of guanfacine and mindfulness training over six weeks. They will take part in sessions that assess their feelings of craving, anxiety, and stress, using guided imagery exercises. This study aims to find out if combining these treatments can help individuals manage their cravings and emotions better than using either treatment alone. It's important to note that the trial is not yet recruiting participants, and individuals interested in joining will need to meet specific health and safety criteria.

Gender

ALL

Eligibility criteria

• 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.