Guanfacine + Mindfulness for Opioid Use Disorder

Overseen By Suchismita Ray, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Buprenorphine

Must not be taking: Cerebral function drugs

Disqualifiers: Severe substance use, Psychotic, Hypotensive, Pregnant, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

224 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{3 6 7 8 9}

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

I have been on BUP for opioid use disorder for at least 4 weeks.

Positive urine toxicology screen for non-prescription opioids

Able to read English and provide informed consent

Exclusion Criteria

R33 phase will additionally include failure to satisfy fMRI safety protocols

Current SCID V criteria for a moderate to severe substance use disorder other than opioids or nicotine (mild use permitted)

Psychotic or severely psychiatrically disabled (i.e. suicidal, current mania)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Guanfacine extended release or placebo, combined with either Mindfulness Oriented Recovery Enhancement or a Support Group control for 6 weeks

6 weeks

Weekly visits for intervention sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Neuroimaging Study

Participants undergo fMRI scans to assess brain activation and connectivity during exposure to stress, opioid, and neutral scripts

Concurrent with treatment phase

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?

Group I: MORE Group Experimental Treatment 1 Intervention

Will receive MORE intervention and placebo medication

Group II: Guanfacine Group Experimental Treatment 1 Intervention

Will receive Guanfacine intervention and Support group control (non-mindfulness) intervention

Group III: Combined Group Experimental Treatment 2 Interventions

Will receive both Guanfacine pharmacotherapy and MORE intervention

Group IV: Control Group Active Control 1 Intervention

Will receive placebo and support group control (non-mindfulness)

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study of 30 individuals undergoing methadone maintenance treatment (MMT), those who participated in Mindfulness-Oriented Recovery Enhancement (MORE) experienced significantly fewer days of illicit drug use and lower cravings compared to those receiving standard treatment alone over a 16-week follow-up period.

Participants in the MORE group also reported reduced pain, lower levels of depression and anxiety, and improved well-being and social functioning, suggesting that MORE may effectively address both chronic pain and opioid use disorder in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized clinical trial of mindfulness-oriented recovery enhancement as an adjunct to methadone treatment for people with opioid use disorder and chronic pain: Impact on illicit drug use, health, and well-being. Cooperman, NA., Hanley, AW., Kline, A., et al.[2022]

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM) was developed and validated to assess therapist competence and adherence to the MORE treatment manual, showing high internal consistency and adequate reliability across 40 treatment sessions involving 295 participants.

Higher fidelity in delivering the MORE treatment was linked to significant reductions in opioid misuse, suggesting that the MORE-FM is an effective tool for ensuring treatment integrity and predicting positive clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. Hanley, AW., Garland, EL.[2022]

The 8-week Mindfulness-Oriented Recovery Enhancement (MORE) intervention significantly improved emotional regulation in women undergoing treatment for opioid use disorder, as evidenced by decreased difficulty in managing emotions after the program.

Functional MRI results showed increased connectivity in brain regions associated with affect regulation after the MORE intervention, suggesting that this mindfulness approach may enhance brain function related to emotional control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample. Ray, S., Bhanji, J., Kennelly, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10817805/

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].

2. psychiatryonline.org psychiatryonline.org/doi/10.1176/ajp.141.10.1271

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.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/6148895/

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_trial

Efficacy 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 ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/070674378703200807

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.pdf

Guanfacine (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.

7. go.drugbank.com go.drugbank.com/drugs/DB01018

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 ...

8. fda.gov fda.gov/files/drugs/published/N22-037-S011-Guanfacine-Clinical-PREA.pdf

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.pdf

Guanfacine hydrochloride (Standard) 1.1 Product identifier. Product name : Guanfacine (hydrochloride) (Standard). Catalog No. : HY-17416R. CAS No. : 29110-48-3.