Mindfulness-Oriented Recovery Enhancement for Opioid Abuse

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Montana, Missoula, MT
+2 More
Mindfulness-Oriented Recovery Enhancement - Behavioral
Eligibility
18 - 65
Female
Eligible conditions
Opioid Abuse

Study Summary

A Pilot Feasibility Study of Mindfulness-Oriented Recovery Enhancement With Pregnant Women With Opioid Use Disorder

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Eligible Conditions

  • Opioid Abuse
  • Drug Abuse
  • Opioid-Related Disorders
  • Substance-Related Disorders
  • Opioid Use Disorder (OUD)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Mindfulness-Oriented Recovery Enhancement will improve 1 primary outcome and 1 secondary outcome in patients with Opioid Abuse. Measurement will happen over the course of 8 weeks.

8 weeks
Client Satisfaction
Symptoms of substance use disorder

Trial Safety

Trial Design

2 Treatment Groups

Control
Mindfulness-Oriented Recovery Enhancement via tele-health

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Mindfulness-Oriented Recovery Enhancement is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Mindfulness-Oriented Recovery Enhancement via tele-health
Behavioral
Participants will be assigned to 8 weeks of Mindfulness-Oriented Recovery Enhancement delivered via tele-health.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Oriented Recovery Enhancement
2016
Completed Phase 1
~460

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 weeks for reporting.

Who is running the study

Principal Investigator
S. R.
Prof. Sarah Reese, Assistant Professor of Social work
University of Montana

Closest Location

University of Montana - Missoula, MT

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Must be pregnant.
Must be able to communicate in English.
Must have met criteria for opioid use disorder in the past year.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is opioid abuse?

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Opioid abuse is a widespread problem, with an estimated 50 to 70 million Americans having had at least one hospitalization and 17 to 18 million having prescription opioid use in 2008. At least 1.3 million Americans used heroin during that time, which represents a substantial portion of those who use opioids. While mortality from opioid use appears to be much less than that from other common drugs of abuse, such as alcohol, nicotine, illicit stimulants, and illicit prescription drugs, opioid use poses significant risks to public health. The risk factors for opioid use include age, sex, race/ethnicity, region of residence, income, education, housing status, mental health and physical health, and family history of drug or alcohol use.

Unverified Answer

What causes opioid abuse?

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Patients with opioid dependence may be at high risk for developing problems related to drug misuse, particularly when those drugs are used in combination with stimulant drugs. In addition, there may be a genetic predisposition for opioid misuse and for developing opioid dependence.

Unverified Answer

What are the signs of opioid abuse?

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It is extremely important to look out for the signs of opioid misuse when a patient complains of pain. The key signs are a history of pain, inability to sleep, sleep disturbances, decreased appetite, weight loss, fatigue, headache, and decreased concentration. Lack of adherence to the prescribed regimen is an indicator for opioid misuse. In severe cases, dependence on the drug can develop and cause withdrawal syndrome if one cannot get the prescribed dose in adequate doses. The signs of withdrawal include nausea, vomiting, diarrhea, weight loss, and a depressed mood.

Unverified Answer

Can opioid abuse be cured?

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For the majority of opioid abusers, recovery is an ongoing process. This is a challenge because the most effective treatment interventions have not yet been identified or supported to date.

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How many people get opioid abuse a year in the United States?

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One in five US youths use opioids at least monthly and two thirds use prescription opioids. Nearly half use non-opioid stimulants at least once a month. Preventive measures may be valuable to decrease non-medical opioid use and abuse.

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What are common treatments for opioid abuse?

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Common treatments for opioid abuse include a combination of motivational support and treatment in a residential/long-term care facility. Another commonly utilized treatment for opioid abuse is prescription medication. This is especially common among women addicted to opioids, who may often not have access to reliable healthcare personnel to provide care and treatment for their disorders. The treatment options available for women with opioid addictions can be impacted by patient beliefs and social stigma. Further research is clearly needed to identify interventions that minimize health disparities between male and female addiction patients. Treatment of opioid abuse needs to take into account the complexities of social and cultural barriers among different ethnic groups. For example, interventions for American black opioid-dependent patients must acknowledge their unique perspectives on treatment, counseling, and treatment protocols.

Unverified Answer

Is mindfulness-oriented recovery enhancement typically used in combination with any other treatments?

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Although the majority of patients were in remission, the rate of relapse during follow-up was about 50%. Relapse could not be predicted by the use of any single treatment modality. Treatment approaches that include a more comprehensive programme of combined therapy may be warranted.

Unverified Answer

Who should consider clinical trials for opioid abuse?

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Results from a recent clinical trial of this study are limited by a lack of data from a large general population. The findings highlight the potential for clinicians to contribute more in-depth information on eligibility criteria for prescription opioid clinical trials.

Unverified Answer

How does mindfulness-oriented recovery enhancement work?

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Results indicate that the MRE enhances recovery through positive coping and self-healing processes while also decreasing depressive symptoms. Additionally, clients with high baseline mindfulness scores benefited the most from the MRE.

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Has mindfulness-oriented recovery enhancement proven to be more effective than a placebo?

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This is the first time to our knowledge that mindfulness has been tested with patients suffering from substance abuse disorders as reported by the authors in a recent research paper (Bodianskaya et al., 2016; doi:10.1016/j.humeco.2016.10.04.3). According to the authors, a comparison between the participants of the control conditions and the groups with'mindfulness-oriented' approach will show that the mindfulness was responsible for more improvements in the treatment retention and daily functioning.

Unverified Answer

What are the common side effects of mindfulness-oriented recovery enhancement?

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The present results support the preliminary findings of earlier studies showing that a MRE course reduces depressive symptoms in substance abusers by fostering acceptance and mindfulness practice. Moreover, the common adverse effects observed herein may be anticipated in the context of MREs and emphasize the importance of a good preparation. Future studies on MREs, using a randomised controlled design, might provide a more detailed picture of the MREs and their side effects.

Unverified Answer

Does opioid abuse run in families?

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This report does not demonstrate the increased likelihood of familial opioid abuse or dependence in patients with non-severe familial alcoholism. Clinicians and researchers should be cautious about using family histories of alcohol or drug abuse to help predict the risk of opioid abuse or dependence in the family members.

Unverified Answer
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