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New treatment option for Mindfulness
Official title Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Maintenance in Opioid Use Disorder
ClinicalTrials.gov ID: NCT06642181
What this study is testing
What is Guanfacine pharmacotherapy?
Guanfacine pharmacotherapy is an investigational medicine, given as an once-weekly, being studied as a potential treatment for mindfulness.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Newark, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.