MI + MORE + NRT for Substance Abuse

Recruiting at 1 trial location

Overseen By Eric Garland, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Methadone

Must not be taking: Smoking cessation drugs

Disqualifiers: Severe cognitive impairment, psychosis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests treatments aimed at reducing the use of opioids, tobacco, and other drugs. It focuses on two main methods: Motivational Interviewing, a counseling approach that encourages behavior change, and Mindfulness-Oriented Recovery Enhancement, a therapy that combines mindfulness, positive emotion, and meaning in life. Participants will join different groups to determine which combination of treatments is most effective. This trial suits English-speaking adults currently on methadone who smoke cigarettes. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be on methadone and cannot be using smoking cessation medications.

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 safe for individuals dealing with addiction and stress. Studies have found that this method reduces cravings and improves emotional well-being, with no major side effects reported. MORE emphasizes mindfulness and positive feelings, which many participants find manageable.

Motivational Interviewing (MI) is another component of the treatment. This counseling method encourages behavior change and is widely used and considered safe. Participants typically find it supportive and helpful, with minimal risk of negative reactions.

These treatments have been studied in various settings and are generally well-received by those seeking help for substance abuse. While no treatment is entirely without risk, current evidence supports the safety of these approaches for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they combine two innovative approaches—Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE)—to tackle substance abuse. Unlike traditional methods that may focus solely on behavioral therapy or medication, this approach leverages MI's strength in enhancing motivation for change and MORE's focus on mindfulness to reduce cravings and increase well-being. This combination aims to address both the psychological and emotional aspects of addiction, potentially offering a more holistic and effective path to recovery.

What evidence suggests that this trial's treatments could be effective for substance abuse?

Research has shown that Mindfulness-Oriented Recovery Enhancement (MORE) reduces substance use, such as opioids and tobacco. Studies have found that MORE helps people manage cravings and improve overall well-being. Participants in these studies used fewer drugs and experienced better mental health. In this trial, some participants will receive MORE combined with Motivational Interviewing (MI), a counseling approach that encourages behavior change. Other participants will receive different combinations of these interventions, such as MORE without MI or MI with a support group. Together, MORE and MI have shown promise in helping people overcome addiction by addressing both the mental and behavioral aspects of substance use. ^{6 7 8 9 10}

Who Is on the Research Team?

Nina Cooperman, PsyD

Principal Investigator

Rutgers Robert Wood Johnson Medical School

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who smoke cigarettes and are currently on methadone. It's not suitable for those unable to attend sessions, pregnant or breastfeeding individuals, people with severe cognitive issues or psychosis, high suicidal risk, previous mindfulness training, or those already in smoking cessation programs.

Inclusion Criteria

I am currently taking methadone.

English-speaking

You are currently a cigarette smoker.

Exclusion Criteria

You have a high risk of feeling suicidal, as indicated by a questionnaire.

I cannot attend or fully participate in all required sessions or assessments.

I am currently trying to quit smoking with medication or counseling.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement interventions

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement

Trial Overview The study tests the effectiveness of combining Motivational Interviewing (MI) and Mindfulness-Oriented Recovery Enhancement (MORE) with Nicotine Replacement Therapy (NRT) to reduce opioid, tobacco, and other drug use. Participants will be grouped into different combinations of support groups, MI, MORE, and NRT.

How Is the Trial Designed?

Group I: MORE and No MI Experimental Treatment 1 Intervention

Group II: MORE and MI Experimental Treatment 1 Intervention

Group III: Support Group and MI Active Control 1 Intervention

Group IV: Support Group and No MI Active Control 1 Intervention

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

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]

Motivational interviewing (MI) may lead to a small to moderate reduction in substance use compared to no intervention, particularly in the short term, based on a systematic review of 93 studies involving 22,776 participants.

MI shows slight benefits over assessment and feedback in reducing substance use in the medium and long term, but it appears to have little to no effect compared to treatment as usual or other active interventions, indicating that its effectiveness may vary depending on the context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing for substance use reduction. Schwenker, R., Dietrich, CE., Hirpa, S., et al.[2023]

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]

Rolling Mindfulness-Based Relapse Prevention (MBRP) is feasible and acceptable for adults in short-term residential treatment for substance use disorders, with good attendance and high satisfaction reported among participants.

Attending more than one session of Rolling MBRP significantly improved mental health and mindfulness at discharge, suggesting that mindfulness practice is a crucial mechanism that enhances the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open trial of rolling admission mindfulness-based relapse prevention (Rolling MBRP): feasibility, acceptability, dose-response relations, and mechanisms. Roos, C., Kirouac, M., Stein, E., et al.[2020]

Mindfulness-based relapse prevention (MBRP) is particularly effective in reducing substance use for individuals with high levels of substance use disorder (SUD) symptoms, as well as those with both high SUD and depression/anxiety symptoms, based on data from two randomized trials involving a total of 454 participants.

In contrast, MBRP showed no significant effects for individuals with low levels of SUD symptoms and depression/anxiety, suggesting that this treatment may be best suited for those with more severe symptom profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline patterns of substance use disorder severity and depression and anxiety symptoms moderate the efficacy of mindfulness-based relapse prevention. Roos, CR., Bowen, S., Witkiewitz, K.[2019]

An eight-week mindfulness-based relapse prevention (MBRP) program was tested on 20 cannabis users, but preliminary results showed no significant difference in the number of joints smoked compared to those receiving standard treatment.

Despite the lack of significant quantitative results, many participants in the MBRP group reported positive qualitative changes in their cannabis consumption, suggesting that mindfulness may still play a beneficial role in managing substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. Schneegans, A., Bourgognon, F., Albuisson, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12305820/

Implementation and Effectiveness of Mindfulness-Oriented ... ... addiction treatment outcomes. Mindfulness-Oriented Recovery Enhancement (MORE) is an 8-week group intervention that integrates training in ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2789279

Mindfulness-Oriented Recovery Enhancement vs ... ... Addiction Behaviors Checklist were considered positive results. ... data collection (compensated by the National Institute on Drug Abuse grant).

3. link.springer.com link.springer.com/article/10.1007/s12671-022-01964-x

Mindfulness-Oriented Recovery Enhancement for Addictive ... Millions more were impacted by the deleterious consequences of addiction ... abuse, and addiction in chronic pain: A systematic review and data ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3532846/

Mindfulness-Oriented Recovery Enhancement for Alcohol ... Recent quantitative research indicates that participation in mindfulness interventions for addiction leads to reductions in substance use (Bowen ...

5. education.sudtraining.org education.sudtraining.org/Listing/Healing-the-Opioid-Crisis-with-Mindfulness-Oriented-Recovery-Enhancement-Outcomes-and-Mechanisms-of-An-Evidence-Based-Therapy-for-Chronic-Pain-Opioid-Misuse-Addiction-On-Demand-13224

Healing the Opioid Crisis with Mindfulness Oriented Recovery ... ... addiction, stress, and pain. This session will detail the theory underlying MORE, research data demonstrating MORE's effectiveness, and unique clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11342816/

Virtual reality-based Mindfulness-Oriented Recovery ... Rockville (MD): Substance Abuse and Mental Health Services ... Mindfulness-Oriented Recovery Enhancement for addiction, stress, and pain.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4752876/

Mindfulness-Oriented Recovery Enhancement Versus CBT ... Mindfulness-Oriented Recovery Enhancement for Addiction, Stress, and Pain. ... Seeking safety: A treatment manual for PTSD and substance abuse. Guilford ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/68/NCT04491968/Prot_SAP_001.pdf

Mindfulness Oriented Recovery Enhancement for Chronic ... Mindfulness-Oriented Recovery Enhancement for Addiction, Stress, and Pain. ... Substance Abuse and Addiction Collection of the PhenX Toolkit www.phenxtoolkit.org.

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/35/NCT02602535/SAP_000.pdf

Mindfulness-Oriented Recovery Enhancement for Opioid ... Accordingly, this project funded by the National. Institute on Drug Abuse (NIDA) is a randomized clinical trial (RCT) of MORE to reduce opioid.

10. drericgarland.com drericgarland.com/tag/craving/

craving Archives - Eric L. Garland, Ph.D. ... meditation—taps into this same mechanism to promote recovery from addiction. ... MORE and Mindful Savoring Highlighted by the National Institute on Drug Abuse.