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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to 1) examine barriers and facilitators to implementation of MI and MORE for polysubstance use and evaluate strategies for optimizing training, fidelity, and clinic uptake, and 2) evaluate patient outcomes related to the effectiveness of MORE decreasing opioid, tobacco, and other drug use.

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.

What data supports the effectiveness of the treatment MI + MORE + NRT for Substance Abuse?

Mindfulness-Oriented Recovery Enhancement (MORE) has shown promise in helping people recover from substance use disorders, including opioid use disorder, by improving emotional regulation and mental health. Mindfulness-based interventions, like MORE, have been positively received by individuals recovering from alcohol and opioid use disorders, suggesting they may be effective in supporting recovery. ^{1 2 3 4 5}

Is the MI + MORE + NRT treatment safe for humans?

The studies on Mindfulness-Oriented Recovery Enhancement (MORE) and mindfulness-based interventions suggest they are generally safe for people recovering from substance use disorders, with high engagement and satisfaction reported by participants. ^{1 2 3 4 6}

How is the MI + MORE + NRT treatment for substance abuse different from other treatments?

The MI + MORE + NRT treatment is unique because it combines Motivational Interviewing (MI), which helps people find their own reasons to change, with Mindfulness-Oriented Recovery Enhancement (MORE), a therapy that integrates mindfulness and positive psychology, and Nicotine Replacement Therapy (NRT). This combination addresses both the psychological and physical aspects of substance abuse, making it a comprehensive approach. ^{1 2 3 7 8}

Research Team

Nina Cooperman, PsyD

Principal Investigator

Rutgers Robert Wood Johnson Medical School

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Perceptions about mindfulness-based interventions among individuals recovering from opioid and alcohol use disorders: Findings from focus groups. [2020]

2. United States 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. [2022]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An open trial of rolling admission mindfulness-based relapse prevention (Rolling MBRP): feasibility, acceptability, dose-response relations, and mechanisms. [2020]

5. France pubmed.ncbi.nlm.nih.gov

Mindfulness-based relapse prevention for cannabis regular users: Preliminary outcomes of a randomized clinical trial. [2022]

6. United States 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. [2019]

7. United States 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. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Motivational interviewing for substance use reduction. [2023]