Treatment for Opioid Abuse

Phase-Based Estimates
1
Effectiveness
1
Safety
Virginia Commonwealth University, Richmond, VA
Opioid Abuse+2 More
Eligibility
18+
All Sexes
Eligible conditions
Opioid Abuse

Study Summary

This study is evaluating whether a drug may help individuals with opioid use disorder.

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Eligible Conditions

  • Opioid Abuse
  • Opioid-Related Disorders
  • Analgesics, Opioid
  • Drug Drug Interaction (DDI)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Treatment will improve 6 primary outcomes and 5 secondary outcomes in patients with Opioid Abuse. Measurement will happen over the course of Change from baseline to discharge, up to 24 hours.

Hour 24
Change in Blood Pressure
Change in Buprenorphine Plasma Concentration (PK)
Change in Lemborexant PK
Change in drug effects
Change in objective opioid withdrawal
Change in opioid withdrawal effects
Impulsivity
Hour 24
Change in pulse oximetry
Hour 24
Change in opioid craving
Change in patient consciousness
Change in respiration

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Placebo Arm
Placebo group

This trial requires 18 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Placebo Arm
Drug
Comparative placebo, all subjects will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.
Lemborexant Arm
Drug
Study Drug Dosage: 5 mg of lemborexant, and 10 mg of lemborexant, all subjects will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to discharge, up to 24 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to discharge, up to 24 hours for reporting.

Closest Location

Virginia Commonwealth University - Richmond, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Urine drug screening will be conducted during screening and on admission to the clinical research unit to verify that the participant is using buprenorphine. show original
Please read and understand the study procedures, and sign this form to consent to participate in the study show original
The person has been using opioids regularly, to the point that it has caused significant problems in their life, and they are currently receiving medication-assisted treatment using buprenorphine-naloxone in a dose of 8mg/2mg to 24mg/6mg or buprenorphine in a dose of 5.7mg/1.4mg to 17.1/4.3 once daily for at least the last two weeks. show original
People aged 18 to 65 years old, both male and female. show original
You have a Pittsburgh Sleep Quality Index total score of 6 or higher if you have a score of 6 or higher on the Pittsburgh Sleep Quality Index. 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.

Can opioid abuse be cured?

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With correct treatment, most drug abusers regain control and/or reduction in usage. However, significant numbers of individuals never successfully achieve remission of drug use. Current addiction treatment programs are under-utilized.

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What are the signs of opioid abuse?

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The symptoms of opioid overdose that are most common are gastrointestinal and neurological. More subtle signs of opioid abuse are likely to manifest with the duration of heroin use.\n

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What are common treatments for opioid abuse?

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Frequent treatments for opioid abuse include medical and dental care, psychological counseling, and medication-assisted treatment or naloxone. These treatments may be utilized by nonhealth professionals to help patients overcome their opioid dependence.

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What is opioid abuse?

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Opioid abuse is a highly prevalent and potentially under-recognized problem that is associated most with heroin use and misuse, especially for the poor. Many more people experience heroin use and overdose of other opioids through prescription/over-the-counter prescription drugs than other street drugs.

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What causes opioid abuse?

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It is more important to identify causes of opioid abuse, than to treat only the abuse itself. Opioid use may be increased by genetic susceptibility, stress responses to physical pain and exposure to stressful events such as natural disasters and wars.

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

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About 10% of men and 10-22% of women in the United States misuse opioids. More than 3 million opioid abusers will have an overdose in the year 2010.

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Is treatment typically used in combination with any other treatments?

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The majority of patients are not taking more than one other drug for the treatment of acute severe illness. Despite this, there was no consistent use of guideline-recommended treatments. The role of the clinical pharmacist during patients' hospitalizations should be explored, as pharmacokinetics and pharmacodynamics do not account for all interactions.

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What is the latest research for opioid abuse?

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There have been many studies that have been published with the topic titled “Opioid abuse.” However, this research focuses on the symptoms, causes, and treatments for both illicit and medical opioid abuse rather than the prevention of it. It is very important that clinicians and addicts learn as much information as possible about how to deal with opioid abuse to help them recover. There are different prevention methods that have been found to help prevent this, although they have not been thoroughly studied.

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What is the average age someone gets opioid abuse?

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Although there is not a consensus about the average age of onset of opioid abuse, our study shows that opioid use has increased over time. The number of patients on methadone and buprenorphine increased in parallel with the number of patients age 20 years or older on a opioid maintenance treatment. This finding may imply that opioid dependence has become more prevalent over time.

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Does treatment improve quality of life for those with opioid abuse?

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Treatment of opioid abuse is associated with improvement in HRQL. If validated the findings of this pilot study suggest the HRQL effects could potentially have implications beyond improved quality of life.

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Have there been other clinical trials involving treatment?

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A total of 6 trials have been published since [the last review for a minimum of 10 years] using opioid-based drugs as treatment for chronic, moderate to severe pain. Several of these studies may be helpful in further [treatment] choices. However, none are specifically tailored to either opioid-based or co-mixed-mixed opioid use. One of the two trials is specifically geared toward a co-mixed-mixed use population, though it has yet to be submitted for publication (http://www.researchgate.

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How serious can opioid abuse be?

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Opioid overdoses are a significant health problem, and urgent and effective intervention is needed. The rate of fatal overdoses is more than 10 times higher than for any other drug, and deaths are more common in elderly women than in other populations. While the risk of overdose death increases with age, the risk of overdose death is significantly greater in people aged less than 40 years who are abusing opioids than in people aged 70 years or older who are abusing opioids.

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