Buprenorphine/naloxone for Opioid Abuse

Phase-Based Estimates
The Pennsylvania Psychiatric Institute, Harrisburg, PA
+1 More
Buprenorphine/naloxone - Drug
All Sexes
Eligible conditions
Opioid Abuse

Study Summary

Buprenorphine Induction for Fentanyl Dependent Opioid Users

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Eligible Conditions

  • Opioid Abuse
  • Opioid-Related Disorders
  • Opioid Dependence Fentanyl

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Buprenorphine/naloxone will improve 1 primary outcome, 1 secondary outcome, and 1 other outcome in patients with Opioid Abuse. Measurement will happen over the course of 7 days.

7 days
Attrition rate measures
Number of patients on Buprenorphine at the end of 7 day induction period
Opioid withdrawal assessment

Trial Safety

Safety Estimate

1 of 3

Side Effects for

infections and infestations
gastrointestinal disorders
injury, poisoning, and procedural complications
nervous system disorders
musculoskeletal and connective tissue disorders
psychiatric disorders
general disorders and administration site conditions
skin and subcutaneous tissue disorders
alanine aminotransferase increased
respiratory, thoracic, and mediastinal disorders
aspartate aminotransferase increased
gamma glutamyltransferase increased
back pain
upper respiratory tract infection
weight increased
congenital anomaly
This histogram enumerates side effects from a completed 2010 Phase 4 trial (NCT00315341) in the Methadone ARM group. Side effects include: infections and infestations with 48%, investigations with 41%, gastrointestinal disorders with 33%, injury, poisoning, and procedural complications with 24%, nasopharyngitis with 23%.

Trial Design

2 Treatment Groups

No Control Group
Micro or Low Dose

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Buprenorphine/naloxone is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Micro or Low Dose
Micro or Low Dose Visit 1 Day 1 (intake/baseline) Participants will commence induction with a dose of 4mg if COWS is above 7. If COWS is below 7, participant will be instructed to return the next day, so that COWS can be above 7 to start the study. (These participants can still be in the study and will only have to re-do a baseline COW's on the day they come back to the clinic, which will then be considered their day 1).
Macro or High Dose
Macro or High Dosing Visit 1 Day 1 (intake/baseline) Participants will commence induction with a dose of 4mg if COWS is above 7. If COWS is below 7, participant will be instructed to return the next day, so that COWS can be above 7 to start the study. (These participants can still be in the study and will only have to re-do a baseline COW's on the day they come back to the clinic, which will then be considered their day 1).
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 days for reporting.

Who is running the study

Principal Investigator
S. K.
Prof. Sarah Kawasaki, Assistant Professor, Department of Psychiatry and Behavioral Health
Milton S. Hershey Medical Center

Closest Location

The Pennsylvania Psychiatric Institute - Harrisburg, PA

Eligibility Criteria

This trial is for patients born any sex 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:
18 years of age or older
Diagnosis of opioid use disorder (OUD) as determined through routine clinical care
Positive for fentanyl on point of care urine drug screen
Ability to read, write, and comprehend English
Patients willing to start buprenorphine at the onset of treatment (e.g., clinical intake)
Patients who need to initiate a buprenorphine induction at home must have an operating smartphone or tablet device with video capability.

Patient Q&A Section

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

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

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About 5% of the American adult population take, use, or abuse opioids at any given time. Each year, an average of 8.9 million Americans take opioids for a variety of reasons. More than 18 million Americans will start abusing opioids within the year, a rate of 5.9%. The rate of abuse in the United States will increase the more frequently opioids are prescribed.

Unverified Answer

What causes opioid abuse?

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Abusers show more severe psychological problems, more frequently abuse drugs other than prescription opioids. In addition, they report more frequent psychological consequences than nonabusers, although they do not experience fewer physical health difficulties.

Unverified Answer

Can opioid abuse be cured?

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There is only one effective treatment to cure opioid addiction and to prevent it from occurring again: abstinence. However, since opioid treatment centers only offer treatment to addicts and not healthy people, it is not feasible to treat opioid addictry in the wider society. Nevertheless, a significant number of addicts has succeeded in a [treatment center with the aim of obtaining permanent abstinence and staying clean for life; this procedure is called treatment oriented permanent abstinence, TOPA, program in English] and this approach to treatment is still under development and used only in a few places around the world. Although TOPA is promising for treating the addiction of other drugs as well as that of opioids, further research is necessary before it can become a global procedure.

Unverified Answer

What is opioid abuse?

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Opioid abuse is an important and evolving problem in the adult population with an accelerating prevalence, which may also be due in part to high rates of comorbidity with other substance misuse and psychiatric disorders.

Unverified Answer

What are the signs of opioid abuse?

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Opioid abuse is a major public health problem and affects most adults and youth in the USA. Symptoms of opioid abuse typically appear during or following opioid use. Symptoms can be severe and include\nhyperalgesia, hyper- and hypoesthesia, increased sweating, insomnia, confusion, panic attacks, and hallucinations. These symptoms can result in physical abnormalities, including increased heart rate, hypertension, and increased breathing rate. Those affected by opioid abuse may be tempted by their symptomatic relief from their addiction to take unscheduled doses prescribed by their physician (i.e. codeine, oxycodone, heroin). These unsupervised doses can lead to severe opioid-related adverse effects, including\ndeath from overdose.

Unverified Answer

What are common treatments for opioid abuse?

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There are several different therapeutic approaches used by family physicians to address prescription opioid addiction. A variety of medical and psychological strategies are used by physicians to treat opioid addiction in their patients. The treatment of chronic pain with an opioid-based opioid replacement therapy and opioid substitution therapy continue to be the preferred methods for opioid addiction treatment.

Unverified Answer

How does buprenorphine/naloxone work?

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Buprenorphine/naloxone combination therapy was more effective than buprenorphine monotherapy at decreasing opioid-induced withdrawal in a rat model. Buprenorphine/naloxone combination therapy was equally effective as naloxone. The withdrawal alleviation is due to the agonism of naloxone, which inhibits the opioid withdrawal effect of mu-opioid receptors.

Unverified Answer

What are the common side effects of buprenorphine/naloxone?

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Participants were generally satisfied with the study, found it a good intervention, the B/N kit was a good investment for reducing drug use, no serious side effects were reported, and participants reported greater confidence that they had completed abstinence. However, it is not known whether B/N kit use is associated with increased risk of relapse.

Unverified Answer

Is buprenorphine/naloxone safe for people?

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This systematic review provides comprehensive evidence that the safety of buprenorphine/naloxone treatment in people with drug use disorder is not compromised. Although further rigorous clinical trials are needed to confirm this finding for certain subgroups, buprenorphine/naloxone can have a place in the treatment of people with opioid dependence.

Unverified Answer

Have there been other clinical trials involving buprenorphine/naloxone?

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There has been no comparative buprenorphine/naloxone clinical trial in which participants received buprenorphine/naloxone or a placebo. Therefore, no conclusive evidence could be drawn as to whether the buprenorphine/naloxone combination can effectively treat or prevent opioid abuse.

Unverified Answer

What is buprenorphine/naloxone?

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The most commonly used routes of administration in this study include [inserting the needle into the nose (35%), placing the tablet under the tongue (42%), or the oral route (20%)]\n. The majority of buprenorphine users [65% of addicts] would prefer to use the nasal route of administration. Data from a recent study highlights the necessity to educate non-drug users on the importance of proper buprenorphine/naloxone use. Therefore, it is important to implement buprenorphine as a part of the treatment plan and educate clients when they first begin using buprenorphine/naloxone for their pain management.

Unverified Answer

Has buprenorphine/naloxone proven to be more effective than a placebo?

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Findings from a recent study supports the use of Buprenorphin/naloxone and buprenorphine/naloxone maintenance treatment for heroin dependent patients seeking treatment. The efficacy of these treatments justifies a higher dose of these treatments and justifies the use of other pharmaceuticals for maintenance treatment.

Unverified Answer
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