Mindfulness Therapy for Heroin Addiction
(MORE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must be taking: Methadone, MAT
Disqualifiers: Schizophrenia, Neurological disease, Cardiovascular, others
No Placebo Group
Trial Summary
What is the purpose of this trial?In this study, neuroimaging of reward processing, drug cue reactivity and inhibitory control is used before and immediately after 8 weeks of two types of group therapy in individuals with opioid addiction; clinical outcomes will be assessed before, immediately and three months after treatment. Results could point to factors that track and predict recovery with treatment, offering clinicians markers that can be used for enhancing precision medicine with the goal of reducing morbidity and mortality associated with opiate addiction.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires participants to be stabilized on methadone or another form of medication-assisted treatment (MAT).
What data supports the effectiveness of the treatment Mindfulness-Oriented Recovery Enhancement (MORE) for heroin addiction?
Research shows that Mindfulness-Oriented Recovery Enhancement (MORE) is effective in helping people recover from opioid use disorder, which includes heroin addiction. It combines mindfulness training, cognitive behavioral therapy, and positive psychology to support recovery and has shown positive effects in reducing substance use and improving well-being.
12345Is Mindfulness-Oriented Recovery Enhancement (MORE) safe for humans?
The research on Mindfulness-Oriented Recovery Enhancement (MORE) does not specifically mention safety concerns, suggesting it is generally considered safe for use in humans, as it is being tested in clinical settings for opioid use disorder and other conditions.
23456How is the Mindfulness-Oriented Recovery Enhancement treatment different from other treatments for heroin addiction?
Mindfulness-Oriented Recovery Enhancement (MORE) is unique because it combines mindfulness training, cognitive behavioral therapy (CBT), and positive psychology to address both addiction and related issues like chronic pain. Unlike standard treatments, MORE focuses on enhancing emotional regulation and well-being, making it a comprehensive approach to recovery.
23457Eligibility Criteria
This trial is for adults aged 18-64 with heroin addiction, specifically those who have chosen heroin as their primary drug and are stabilized on methadone or similar treatments. It's not suitable for individuals with metal implants, serious medical conditions like heart disease, a history of significant head trauma, neurological diseases, schizophrenia, autism spectrum disorders, or infectious diseases such as Hepatitis B/C or HIV/AIDS.Inclusion Criteria
My main addiction is to heroin.
Inclusion criteria for healthy controls: Dependence on nicotine or caffeine is non-exclusionary
I am between 18 and 64 years old.
+2 more
Exclusion Criteria
I have a history of brain-related neurological diseases, including seizures.
I have had a head injury that made me lose consciousness.
I have a condition like high blood pressure, diabetes, cancer, an autoimmune disease, or an infection such as Hepatitis or HIV.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo 8 weeks of group therapy, with neuroimaging assessments conducted immediately before and after treatment
8 weeks
2 MRI scans (pre and post-treatment)
Follow-up
Participants are monitored for clinical outcomes and undergo neuroimaging assessments 3 months after treatment
3 months
1 MRI scan
Participant Groups
The study compares two types of behavioral group therapies to see which is more effective in treating opioid addiction. Participants will undergo brain scans before and after the 8-week therapy sessions to observe changes in reward processing and impulse control. The effectiveness will be evaluated at different stages: before treatment starts, right after it ends, and three months later.
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral group therapy 1Experimental Treatment1 Intervention
8-weeks of group therapy
Group II: Behavioral group therapy 2Active Control1 Intervention
8-weeks of group therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Icahn School of Medicine at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
University of UtahCollaborator
References
Mindfulness-based programs for substance use disorders: a systematic review of manualized treatments. [2021]Substance use disorders are prevalent and returning to substance use (i.e., relapse) following treatment is common, underscoring the need for effective treatments that will help individuals maintain long-term reductions in substance use. Mindfulness-based interventions (MBIs) have been increasingly developed and evaluated for the treatment of substance use disorders. The aim of this article was to update a systematic review conducted by Li et al. in 2017 on the outcomes of randomized control trials of MBIs for substance use disorders. In addition, we provided a session-by-session examination of the most widely used MBI protocols.
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. [2022]Chronic pain is highly prevalent among people in methadone maintenance treatment (MMT) for opioid use disorder and is known to be an important contributor to treatment discontinuation and opioid relapse. Mindfulness-Oriented Recovery Enhancement (MORE) is one of the few interventions developed and tested as an integrated treatment to simultaneously address both pain and illicit opioid use; however, this study is the first to evaluate MORE as an adjunct to MMT.
The Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM): Development and Validation of a New Tool to Assess Therapist Adherence and Competence. [2022]Mindfulness-Oriented Recovery Enhancement (MORE) is a mind-body therapy that unites complementary aspects of mindfulness training, third-wave cognitive behavioral therapy (CBT), and principles from positive psychology into an integrative treatment for addiction and its comorbidities. As interest in MORE has grown among researchers and clinicians, there is an increasing need to provide quality assurance measures to ensure treatment integrity during implementation of MORE. Here, we describe the development and validation of the Mindfulness-Oriented Recovery Enhancement Fidelity Measure (MORE-FM).
Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. [2020]Mindfulness-based interventions (MBIs) have been used as an intervention to support recovery from alcohol use disorder (AUD) and opioid use disorder (OUD). We sought to identify attitudes and experiences toward standardized MBIs among individuals recovering from these substance abuse disorders (SUD) through a qualitative approach.
Mindfulness-oriented recovery enhancement in opioid use disorder: Extended emotional regulation and neural effects and immediate effects of guided meditation in a pilot sample. [2023]Mindfulness-Oriented Recovery Enhancement (MORE) is an efficacious intervention to aid recovery from substance use disorder. This study in a pilot sample of individuals in treatment for opioid use disorder (OUD) characterizes longer-term changes after the MORE intervention and immediate effects of a brief MORE guided meditation session.
Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. [2022]Relapse is highly prevalent following substance abuse treatments, highlighting the need for improved aftercare interventions. Mindfulness-based relapse prevention (MBRP), a group-based psychosocial aftercare, integrates evidence-based practices from mindfulness-based interventions and cognitive-behavioral relapse prevention (RP) approaches.
Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. [2023]As opioid overdose deaths increase, buprenorphine/naloxone (B/N) treatment is expanding, yet almost half of patients are not retained in B/N treatment. Mindfulness-based interventions (MBIs) designed to promote non-judgmental awareness of present moment experience may be complementary to B/N treatment and offer the potential to enhance retention by reducing substance use and addressing comorbid symptoms. In this pilot study, we examined the feasibility and acceptability of the Mindful Recovery OUD Care Continuum (M-ROCC), a trauma-informed, motivationally sensitive, 24-week MBI. Participants (N = 18) were adults with Opioid Use Disorder prescribed B/N. The study team conducted assessments of satisfaction, mindfulness levels, and home practice, as well as qualitative interviews at 4 and 24-weeks. M-ROCC was feasible in a sample with high rates of childhood trauma and comorbid psychiatric diagnoses with 89% of participants retained at 4-weeks and 72% at 24-weeks. Positive qualitative interview responses and a high rate of participants willing to refer a friend (100%) demonstrates program acceptability. Participant mindfulness increased from baseline to 24-weeks (β = 0.24, p = 0.001, d = 0.51), and increases were correlated with informal mindfulness practice frequency (r = 0.7, p