Patient Navigation for Opioid Abuse

1
Effectiveness
1
Safety
University of Utah, Salt Lake City, UT
Opioid Abuse+2 More
Patient Navigation - Behavioral
Eligibility
18+
Female
Eligible conditions
Opioid Abuse

Study Summary

This study is evaluating whether a program which provides pregnant women with opioid use disorder with a variety of services will help them and their children.

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Eligible Conditions

  • Opioid Abuse
  • Opioid-Related Disorders
  • Pregnancy Related
  • High Risk Pregnancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Patient Navigation will improve 4 primary outcomes and 4 secondary outcomes in patients with Opioid Abuse. Measurement will happen over the course of 36 months.

36 months
Adequacy of Prenatal Care
Adherence to Medication-Assisted Treatment (MAT)
Child and mother bond following delivery
Incidence of depression and anxiety
Linkage/Retention in Psychosocial Services
Needle use and safe sex frequency
Opioid Abstinence
Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD) Treatment Linkage/Retention

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Patient Navigation

This trial requires 122 total participants across 2 different treatment groups

This trial involves 2 different treatments. Patient Navigation 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.

Patient Navigation
Behavioral
The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Patient Navigation
2014
Completed Phase 2
~38290

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 36 months for reporting.

Who is running the study

Principal Investigator
J. C.
Prof. Jerry Cochran, Associate Professor
University of Utah

Closest Location

University of Utah - Salt Lake City, UT

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult (≥18 years)
English speaking
Pregnant women (pregnancy status verified by gestational age >6 weeks from last menstrual period confirmed by ultrasound)
OUD verified by examination of medical records for an OUD diagnosis, urine toxicology, and the Diagnostic and Statistical Manual of Mental Disorders (DSM) Checklist (modified from the DSM-IV to confirm current diagnosis for substance use disorders)
Plan to carry their babies to delivery verified by patient self report
Participant

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 causes opioid abuse?

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The most prominent cause of opioid dependence is trauma and/or the abuse of a drug. Opioid abuse does not occur in individuals who have not experienced trauma. Opioid abuse is more likely to occur in persons who abuse other drugs, particularly when both drugs are present, and it is also more common in individuals of lower socioeconomic status. The use of heroin by adolescent boys is a significant factor in the increase of youth hospitalization for overdose among them.

Unverified Answer

What is opioid abuse?

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A recent systematic review found opioids are rarely the cause of overdose fatalities in the US. Opioid use often is attributed to prescription-only pain relievers. The authors suggest the focus be more on reducing overuse and addiction problems, along with raising awareness of the high likelihood of fatal opioid overdose. If available, prescription opioids should be prescribed in a slow, consistent, monitored fashion and only for a certified treatment of pain only. Additionally, efforts should be made to educate doctors and patients about alternatives to prescription opioids, and to discourage use of illicit drugs.

Unverified Answer

What are the signs of opioid abuse?

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There are signs of opioid drug use (and abuse) that can be noticed outside of routine clinical visits or tests. This information would be helpful for physicians, especially after patient encounters. It could be useful in the development of prevention and treatment strategies for opioid abuse.

Unverified Answer

What are common treatments for opioid abuse?

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Naltrexone, nalmefene, and buprenorphine are effective treatments in opioid clinics. However, many heroin abusers were unable to complete their full course of treatment. In fact, a majority of addicts failed to complete the treatment cycle. Additionally, buprenorphine alone is likely to fail to treat most heroin addicts, while nalmefene or naltrexone may be more effective in opiate clinics. Thus, outpatient clinics may not have enough of these treatments available to treat most heroin abusers.

Unverified Answer

Can opioid abuse be cured?

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Methadone therapy can be used as a treatment for opiate addicts. However, we advise that treatment of non-medical opiate use should be continued with proper drug monitoring.

Unverified Answer

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

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The rate of people exposed to opiate abuse in the United States of America during 1999-2003 appears to be less than the national average. If the rates of opiate abuse during 2001-2003 are applied to the national statistics, the number of people exposed to opiates may be significantly lower. However, extrapolations must be adjusted for the time period and the actual incidence rate of opium use and opiate abuse is likely to be higher.

Unverified Answer

Have there been other clinical trials involving patient navigation?

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We found no clinical trials of the patient navigators, but we cannot assert that patients with non-specific symptoms might not benefit from patient navigation. Patient navigation may be an option for treatment of specific physical symptoms by addressing a patient's health needs in a more holistic manner. There is a need for further research in this area.

Unverified Answer

Does opioid abuse run in families?

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Although genetic influences might underlie the increased prevalence of substance use disorders, they do not appear to be a sufficient explanation of the heritability of opioid abuse. Other environmental factors, such as family, school, and social environment, may help to explain the link between parental and societal factors and substance use, but not to the extent of familial factors.

Unverified Answer

What is the average age someone gets opioid abuse?

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The reported average age for abuse onset suggests opioid use occurs earlier in adolescence compared to previously reported rates for heroin, other drugs, alcohol, and marijuana. If such use occurs earlier in adolescence, there may be an opportunity to reduce the incidence of adverse effects associated with the use of opioids.

Unverified Answer

Is patient navigation safe for people?

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Patient-centered approaches for the patient and the providers (navigation) are safe: all involved were informed, no patients were denied care, and there were few concerns about patient safety. Navigation may be helpful for patients with chronic illnesses such as schizophrenia.

Unverified Answer

Have there been any new discoveries for treating opioid abuse?

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Our current treatment for opioid use disorder is not very effective, and the majority of individuals do not benefit greatly from such treatment in the long term because chronic opioid use causes tolerance and/or psychological dependence to the analgesia. Thus, we still need to design and implement clinical studies to test whether other forms of therapies can help to treat opioid users who are resistant to current therapies, as well as explore the reasons for this resistance.

Unverified Answer

Is patient navigation typically used in combination with any other treatments?

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Patient navigators were more likely to be used in combination with other health care interventions. The two major barriers to obtaining navigation were cost (almost half) and difficulty in accessing it (28%). Patients with more disabilities who travel from home to outpatient visit were more likely to be able to seek navigator assistance. If patients are able to access navigators, they are more likely to use other health services, particularly for self-management of illnesses.

Unverified Answer
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