Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) for Opioid Abuse

Phase-Based Estimates
1
Effectiveness
1
Safety
Penn Prevention CRS, Philadelphia, PA
Opioid Abuse+4 More
Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Opioid Abuse

Study Summary

This study is evaluating whether a mobile health unit may help individuals with opioid use disorder and HIV.

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Eligible Conditions

  • Opioid Abuse
  • Opioid-Related Disorders
  • HIV Infections
  • Drug Use
  • Opioid Use Disorder (OUD)
  • Opioids Use

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD) will improve 17 secondary outcomes in patients with Opioid Abuse. Measurement will happen over the course of Up to 52 weeks.

Week 52
Assess whether the intervention increases the proportion of participants with undetectable HCV RNA among those with chronic HCV infection at enrollment
Evaluate whether 26 weeks of "one stop" integrated health services delivered in a mobile health delivery unit, supported by peer navigation, increases MOUD use
Evaluate whether 26 weeks of "one stop" integrated health services delivered in a mobile health delivery unit, supported by peer navigation, increases PrEP use at 26 and 52 weeks
Evaluate whether 26 weeks of "one stop" integrated health services delivered in a mobile health delivery unit, supported by peer navigation, increases viral suppression at 26 and 52 weeks
Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases MOUD use at 26 and 52 weeks
Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases PrEP use at 26 and 52 weeks
Evaluate whether 26 weeks of peer navigation to similar health services available at community-based agencies increases viral suppression at 26 and 52 weeks
Evaluate whether the intervention increases use of PrEP among HIV-negative individuals
Evaluate whether the intervention reduces opioid and polysubstance use at 26 and 52 weeks
Evaluate whether the intervention reduces prevalence of bacterial STIs
Evaluate whether the intervention reduces the rate of fatal overdose events by 26 and 52 weeks
Evaluate whether the intervention reduces the rate of non-fatal overdose events by 26 and 52 weeks
52 weeks
Evaluate whether the intervention improves use of MOUD
Evaluate whether the intervention increases rates of viral suppression among HIV-positive individuals
Evaluate whether the intervention reduces HCV incidence
Week 52
Assess the prevalence of SARS-CoV-2 seropositivity at baseline, 26 and 52 weeks
Up to 52 weeks
Document the impact of the COVID-19 epidemic on participants' experiences of seeking, obtaining and/or maintaining health services, housing, food security and drugs

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Peer navigation to connect them to health services available at community-based agencies
Integrated health services delivered in the mobile unit and peer navigation

This trial requires 860 total participants across 2 different treatment groups

This trial involves 2 different treatments. Medication For Opioid-use Disorder (MOUD) For Opioid-use Disorder (OUD) 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.

Integrated health services delivered in the mobile unit and peer navigationParticipants in the intervention arm will be provided integrated health services delivered in the mobile unit and peer navigation for 26 weeks.
Peer navigation to connect them to health services available at community-based agenciesParticipants in the active control arm will be provided 26 weeks of peer navigation to connect them to health services available at community-based agencies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HIV testing
2013
Completed Phase 4
~710
Peer navigation
2016
Completed Phase 4
~220

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 26 weeks and 52 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 26 weeks and 52 weeks for reporting.

Closest Location

Penn Prevention CRS - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I've shared needles and/or had unprotected sex with someone who is HIV-positive or whose status I don't know in the last three months. show original
The text is saying that the person is able to provide enough locator information. show original
Confirmed HIV status, as defined in the HPTN 094 Study Specific Procedures Manual
People in the age group of 18 to 60 years old. show original
The individual's urine test is positive for opioids and there are signs of recent injection drug use. show original
Diagnosed with OUD per Diagnostic and Statistical Manual of Mental Disorders (DSM)-5
Able and willing to give informed consent
with you I am willing to start treatment with you. show original
(AOU) This person is able to successfully complete an Assessment of Understanding show original

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 use is associated with an increased risk of HIV transmission among PWAs. Further research is needed to better understand the effect of opioid abuse on the epidemic of HIV among PWAs.

Unverified Answer

What are the signs of opioid abuse?

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Signs of opioid abuse are a prolonged increased use of pills and injecting drugs and increased use of heroin, with the majority of cases using multiple routes of administration. They comprise a distinct presentation, which may be a useful marker of abuse.

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Can opioid abuse be cured?

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Patients and families with opioid dependence cannot be cured, but a relatively small number of heroin abusers have had the opportunity to experience freedom from drug usage. These cases illustrate the necessity of a coordinated approach to the treatment of opioid dependence.

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

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There are more than 10 million people misusing opioids a year in the United States, which will result in significant societal and economic burden if left untreated.

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What causes opioid abuse?

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There appears to be a strong genetic tendency to opioid abuse, but the genetic predisposition appears to manifest through the other aspects of the environment.

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What are common treatments for opioid abuse?

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It may be difficult to discontinue a prescription for opioids, in the majority of cases, as many patients are dependent on opioids. CBT for heroin and methadone abusers is available as well as naloxone maintenance. The role of pharmacotherapy in the treatment of opiate dependence is limited. However, due to the addictive potency of opiates, the management and control of addiction is of paramount importance. Other options used for treatment or prevention of opiate use include psychotherapy and buprenorphine maintenance, which is used in a limited but meaningful number of patients.

Unverified Answer

Is medication for opioid-use disorder (moud) for opioid-use disorder (oud) safe for people?

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Medication for opod use could be safely administered to people who meet current criteria for treating a diagnosis of opod. The lack of harm and high acceptability of this treatment have implications for the development of other medications for treating the condition(https://www.cdc.gov/opstheorist/factsheets/treatment/medication.html).

Unverified Answer

Does medication for opioid-use disorder (moud) for opioid-use disorder (oud) improve quality of life for those with opioid abuse?

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The use of the medication moud is associated with improvements of physical health status among people with opioid abuse. Medication moud is also associated with better social functioning, quality of life, and a sense of empowerment and control over the effects of abuse. The benefits of medication moud need to be evaluated prospectively as a means of reducing the risk for other substance use disorders before prescribing it.

Unverified Answer

Is medication for opioid-use disorder (moud) for opioid-use disorder (oud) typically used in combination with any other treatments?

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There are many medications that have not been used in combination with other treatments to treat OUD. For those, a review of the literature is helpful and potentially lead to more effective treatment.

Unverified Answer

Has medication for opioid-use disorder (moud) for opioid-use disorder (oud) proven to be more effective than a placebo?

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Results from a recent paper demonstrate that MDD does not reduce drug effects in terms of decreasing the reinforcing effects of drugs or reducing substance-using in alcohol-dependent individuals. Results from a recent paper suggest that MDD-moud may be inappropriate for this population given the results with a medication more effective than a placebo.

Unverified Answer

What is the primary cause of opioid abuse?

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It is important for patients and clinicians and to prevent opioid abuse, to clarify the etiology associated with opioid use through investigations to the extent possible since treatment will vary based on the etiology.

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Have there been any new discoveries for treating opioid abuse?

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New data suggests that the mu opioid receptor could be a target for controlling substance abuse because of its regulatory functions in the brain. More research needs to be done before this possibility seems to be substantiated.

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