Guanfacine + Mindfulness for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination treatment for individuals with opioid use disorder (OUD) who continue their buprenorphine (BUP) medication. Researchers are testing whether combining guanfacine, a medication that may help with stress-related cravings, with a mindfulness program called Mindfulness Oriented Recovery Enhancement (MORE) can better manage cravings and improve emotional control. Participants will be divided into groups to receive either the medication, the mindfulness program, both, or neither, to determine the most effective combination. The trial seeks individuals who have taken BUP for at least four weeks and have tested positive for non-prescription opioids. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative combination therapy.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that guanfacine, a type of medication, is generally well-tolerated. It treats conditions like ADHD and helps manage stress-related cravings by improving emotional control. However, it can cause side effects such as drowsiness or dry mouth, though serious side effects are rare.
Mindfulness-Oriented Recovery Enhancement (MORE) has also shown promise. Studies have found it effective in reducing opioid cravings and assisting people with chronic pain. As a behavioral approach, it focuses on changing thoughts and reactions to cravings. Most people find it safe and helpful.
This trial tests these treatments both separately and together. While guanfacine is already approved for other uses, MORE is a newer method for treating opioid use disorder. This is an early phase trial, so safety is still closely monitored, but past findings are promising.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Guanfacine and Mindfulness Oriented Recovery Enhancement (MORE) for opioid use disorder because they offer unique approaches compared to standard treatments like methadone or buprenorphine. Guanfacine, typically used for ADHD, targets stress-related pathways, potentially reducing cravings and withdrawal symptoms. MORE combines mindfulness training with cognitive behavioral therapy, aiming to enhance emotional regulation and reduce the risk of relapse. Together, these treatments could provide a holistic approach that not only addresses the physical aspects of addiction but also supports mental and emotional well-being.
What evidence suggests that this trial's treatments could be effective for opioid use disorder?
Research has shown that guanfacine, a type of medication, can help manage opioid withdrawal symptoms by improving emotional control. In earlier studies, individuals taking guanfacine experienced noticeable relief from withdrawal symptoms within just a few days. Mindfulness Oriented Recovery Enhancement (MORE) has also proven effective, reducing opioid misuse by 45% in a large study. MORE helps individuals manage their emotions better, which reduces cravings. In this trial, participants in the Combined Group will receive both guanfacine and MORE, potentially offering a stronger approach to managing opioid use disorder. Meanwhile, other participants will receive either guanfacine alone or MORE alone, allowing for a comparison of their individual effects.36789
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Guanfacine
- Mindfulness Oriented Recovery Enhancement (MORE)
Trial Overview
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.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Will receive MORE intervention and placebo medication
Will receive Guanfacine intervention and Support group control (non-mindfulness) intervention
Will receive both Guanfacine pharmacotherapy and MORE intervention
Will receive placebo and support group control (non-mindfulness)
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
Published Research Related to This Trial
Citations
Guanfacine Treatment in a Patient with Intravenous ...
Studies with α2A receptor agonists showed the efficacy to manage opioid withdrawal symptoms in individuals with opioid use disorder [10, 14].
Preliminary results of guanfacine treatment of acute opiate ...
Ten patients experiencing sudden opiate withdrawal received low doses of guanfacine. Improvement was noticeable within the first 4 days.
Preliminary results of guanfacine treatment of acute opiate ...
Ten patients experiencing sudden opiate withdrawal received low doses of guanfacine. Improvement was noticeable within the first 4 days and was most evident ...
4.
researchgate.net
researchgate.net/publication/229793578_Efficacy_of_clonidine_guanfacine_and_methadone_in_the_rapid_detoxification_of_heroin_addicts_A_controlled_clinical_trialEfficacy of clonidine, guanfacine and methadone in the ...
The efficacy of clonidine, methadone, and guanfacine in rapid detoxification of heroin inpatients was assessed in a randomized controlled ...
Treatment of Heroin Withdrawal with Guanfacine
Thirty-four addicts (29 males, 5 females) aged 17 to 31 years were treated for 5 to 15 days with varying doses of guanfacine (0.03 up to 1.75 mg daily).
6.
imgcdn.mckesson.com
imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9POTEX_GUANFACINE_HCL_ER_TAB_4MG_100BT.pdfGuanfacine (hydrochloride) SAFETY DATA SHEET
2.3. Material may be irritating to the mucous membranes and upper respiratory tract. May be harmful by inhalation or skin absorption.
Guanfacine: Uses, Interactions, Mechanism of Action
The risk or severity of CNS depression can be increased when Guanfacine is combined with Benactyzine. Benazepril, Guanfacine may decrease the ...
N22-037 S011 Guanfacine Clinical PREA
Adverse event safety data were audited for completeness and accuracy in a 5% sample ... disorder, obsessive-compulsive disorder, substance abuse ...
9.
file.medchemexpress.com
file.medchemexpress.com/batch_PDF/HY-17416R/Guanfacine-hydrochloride-Standard-SDS-MedChemExpress.pdfGuanfacine hydrochloride (Standard)
1.1 Product identifier. Product name : Guanfacine (hydrochloride) (Standard). Catalog No. : HY-17416R. CAS No. : 29110-48-3.
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