Mindfulness Therapy for Heroin Addiction

(MORE Trial)

Overseen By Kathryn R Drury

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: Methadone, MAT

Disqualifiers: Schizophrenia, Neurological disease, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of mindfulness therapy for individuals dealing with heroin addiction. Researchers will examine brain activity and behavior changes before and after 8 weeks of therapy to identify factors that may enhance recovery. These findings could assist doctors in tailoring treatments to reduce the harm caused by opioid use. Individuals who have been using heroin and are stable on medications like methadone may be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to more personalized treatment options.

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).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) is generally easy for participants to handle. Studies have found that people using MORE report few, if any, negative effects. For example, research comparing MORE to cognitive behavioral therapy (CBT) found both treatments safe, with no major negative outcomes reported.

Researchers have also tested MORE in different groups, including veterans dealing with pain and opioid use issues. These studies consistently show that MORE can be safely used across various groups.

While specific data on negative effects related to opioid addiction is limited, existing research suggests that MORE is a safe treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for heroin addiction that often rely on medication-assisted therapy, Mindfulness-Oriented Recovery Enhancement (MORE) offers a unique approach by focusing on mental practices. Researchers are excited about MORE because it helps individuals develop mindfulness skills, which can reduce cravings and enhance emotional regulation. This method empowers people to gain more control over their responses to stress and addiction triggers, potentially leading to long-lasting recovery without the side effects associated with medications.

What evidence suggests that this trial's treatments could be effective for heroin addiction?

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE), which participants in this trial may receive, can help reduce opioid use, including heroin. Studies have found that individuals using MORE reported fewer days of heroin use. MORE aids individuals in managing cravings and reacting less to drug-related triggers. This method encourages focusing on healthier coping strategies instead of drug use. Early results suggest that mindfulness practices can also improve emotional control, which is important for recovery. Overall, promising evidence indicates that MORE can be a useful tool in treating heroin addiction. ^{1 6 7 8 9}

Who Is on the Research Team?

Rita Goldstein, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Nelly Alia-Klein, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 understand the study and can give my consent.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral group therapy #1
• Behavioral group therapy #2
• Mindfulness-Oriented Recovery Enhancement (MORE)

Trial Overview

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.

How Is the Trial Designed?

Group I: Behavioral group therapy 1 Experimental Treatment 1 Intervention

8-weeks of group therapy

Group II: Behavioral group therapy 2 Active Control 1 Intervention

8-weeks of group therapy

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

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]

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]

Mindfulness-based interventions (MBIs) have been found to be as effective as traditional treatments for substance use disorders, helping to reduce the frequency and quantity of substance use, cravings, and related problems based on a systematic review of 30 randomized controlled trials.

The review highlights the need for further large-scale studies to explore the best settings and protocols for MBIs, as well as to identify which patient populations may benefit the most from these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based programs for substance use disorders: a systematic review of manualized treatments. Korecki, JR., Schwebel, FJ., Votaw, VR., et al.[2021]

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]

Participants recovering from alcohol and opioid use disorders found mindfulness-based interventions (MBIs) beneficial for their recovery, particularly valuing the non-pharmacological nature of these therapies.

Key factors influencing participation in MBIs included perceived provider empathy and social connectedness, with participants suggesting that incentives like gift cards could enhance engagement and retention in recovery programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. Jones, KO., Lopes, S., Chen, L., et al.[2020]

Mindfulness-based relapse prevention (MBRP) and cognitive-behavioral relapse prevention (RP) significantly reduced the risk of relapse to substance use and heavy drinking compared to treatment as usual (TAU) during a 12-month follow-up with 286 participants.

At the 12-month mark, MBRP participants reported fewer days of substance use and heavy drinking compared to both RP and TAU, suggesting that mindfulness practices can enhance long-term recovery outcomes by helping individuals manage cravings and negative emotions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. Bowen, S., Witkiewitz, K., Clifasefi, SL., et al.[2022]

The pilot study involving 18 adults with Opioid Use Disorder showed that the Mindful Recovery OUD Care Continuum (M-ROCC) was feasible and acceptable, with 89% of participants retained in the program at 4 weeks and 72% at 24 weeks.

Participants demonstrated significant increases in mindfulness over the 24-week period, which correlated with their frequency of mindfulness practice, suggesting that integrating mindfulness-based interventions could enhance retention in buprenorphine/naloxone treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of mindful recovery opioid use care continuum (M-ROCC): A concurrent mixed methods study. Fatkin, T., Moore, SK., Okst, K., et al.[2023]

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This study phase will conduct a clinical trial to assess MORE efficacy and to explore factors impacting the efficacy of MORE on opioid use outcomes.

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