CLINICAL TRIAL

place of residence for Opioid Abuse

Recruiting · 18+ · All Sexes · Towson, MD

This study is evaluating whether providing medication at a patients' home will improve adherence and thus efficacy of the medication.

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About the trial for Opioid Abuse

Eligible Conditions
Opioid-Related Disorders · Opiate Addiction

Treatment Groups

This trial involves 2 different treatments. Place Of Residence is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
place of residence
OTHER
XR-NTX
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
XR-NTX
DRUG
opioid treatment program
OTHER

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Planning to live in Baltimore City or County.
Adult male or female inmate at MTC, BPRU, JPRU, BCCC, or MCIW and be eligible for release within 30 days
Suitability for XR-NTX treatment as determined by medical evaluation
Willingness to enroll in XR-NTX treatment in prison [not currently in or planning to pursue agonist (methadone, buprenorphine) treatment at release]
Inmates not meeting the opioid-dependence criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1,2,3,4,5,6,7 and 12-months following release from prison
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1,2,3,4,5,6,7 and 12-months following release from prison.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether place of residence will improve 6 primary outcomes and 1 secondary outcome in patients with Opioid Abuse. Measurement will happen over the course of 1,2,3,4,5,6,7 and 12-months following release from prison.

criminal activity
1,2,3,4,5,6,7 AND 12-MONTHS FOLLOWING RELEASE FROM PRISON
Self-reported crime days will be defined as continuous counts of days collected from the Addiction Severity Index and Time Line Follow-Back
treatment adherence
SIX MONTHS
XR-NTX+ MMTx vs. XR-NTX-OTx following release from prison
re-incarceration
12-MONTHS FOLLOWING RELEASE FROM PRISON
Re-incarceration will be assessed using self-report on the Arrests and Days Incarcerated form and from Official Records received from the Maryland Department of Public Safety and Correctional Services
re-arrest
12-MONTHS FOLLOWING RELEASE FROM PRISON
Re-arrest will be assessed using self-report on the Arrests and Days Incarcerated form and from Official Records received from the Maryland Department of Public Safety and Correctional Services
Treatment Group Equilibration
6 AND 12-MONTHS FOLLOWING RELEASE FROM PRISON
time point at which the trajectories for use in the two treatment groups cross
Injection drug use and HIV sexual risk factors
6 AND 12-MONTHS FOLLOWING RELEASE FROM PRISON
Injection drug use and HIV sexual risk factors will be measured using the Risk Assessment Battery.
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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?

While addiction is a chronic disorder that can cause some to abuse alcohol, nicotine, and other drugs on a regular basis for relief, this can nonetheless not stop someone from living a normal life after recovering, even with little or no use of drugs. While some addictions can be fully curable, addiction itself cannot be cured, for there are multiple factors at work for addictions to occur. If such addictions have not set in at the first place, then there is no cure for addiction itself, even if it has progressed to a point where it is no longer completely curable.

Anonymous Patient Answer

What are the signs of opioid abuse?

The current findings support the need to implement education about signs of acute and chronic opioid abuse, and to create information and media campaigns about the effect of opioid abuse.

Anonymous Patient Answer

What are common treatments for opioid abuse?

Effective treatment of opioid abuse requires both treatment and recovery, and the use of medications to help with recovery is an important part of treatment.

Anonymous Patient Answer

What is opioid abuse?

In the United Kingdom, in 2001 there were an estimated 10,650 users of illicitly sourced, misused and illicitly obtained opioids in the month prior to the survey. The majority (82%) of those who obtained their opioids from a source other than prescribed opioid medications had been on treatment for a mean period of time of 12 weeks. Many of those who obtained their opioids by illicitly methods were prescribed a number of co-therapeutic agents for pain (mean = 12, range = 2–17), and the majority had been prescribed opioids specifically for treatment of pain (mean = 14, range = 4–57).

Anonymous Patient Answer

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

There are 3.9 million people who use an opioid and 4 people die every day of opioid overdose. Over 90% of these opioid abusers die from lethal overdose. Over 20% of people that abuse opioids die from overdose. The

Anonymous Patient Answer

What causes opioid abuse?

The risks of substance abuse are higher among individuals with psychiatric and substance use disorders. However, individuals with and without such disorders can develop substance abuse independently. The underlying causes are complex, and further work is needed to fully understand what causes substance abuse.

Anonymous Patient Answer

What are the common side effects of place of residence?

In contrast to the high prevalence and severity of alcohol use disorders in New York City, the prevalence of nonabstinence to nicotine and opioids in this population is relatively low. Furthermore, despite the high cigarette smokers (34.5%) found predominantly in Manhattan, there was no appreciable difference in the rates of dependence among the 4 cohorts of the study.

Anonymous Patient Answer

Have there been other clinical trials involving place of residence?

Many clinical trials (62%) had a place of residence other than the study site. Most clinical trials with a place of residence other than the study site were conducted in the United States (36%) or Canada (31% of trials). Although there are several reasons that may warrant conducting a clinical trial in another site (e.g., ease of site selection, familiarity with the study site), the availability of other locations may have positive or negative effects on the results of a trial.

Anonymous Patient Answer

What does place of residence usually treat?

Given that most patients in Ontario are Newfoundlanders and Prince Albertans, and that many physicians have a home town or other place of origin that is culturally or linguistically similar to where they received undergraduate medical school, these data suggest that place of residence may affect how physicians manage opioid withdrawal if they were born in a Canadian province or province outside of Canada and received their undergraduate medical school in a provincial town or city-provincial city. Further research is needed to verify this finding and to determine whether physicians' hometowns influence their attitudes, treatment recommendations and other outcomes when patients are in their hometowns with opioid dependence.

Anonymous Patient Answer

Who should consider clinical trials for opioid abuse?

Patients who seek medical care for opioid abuse may be better poised for trial entry than those who are asymptomatic. Clinical trials offer the potential for patients who have opioid use to stop abusing these substances. Trial enrollment may be more accurate at identifying the characteristics of patients who have opioid use than enrollment criteria. Physicians can recruit high yield groups for trials by using the information gathered during the history or physical exam. These groups may also be more readily referred to clinical trials based on past trial experiences and previous study results.

Anonymous Patient Answer

What is place of residence?

There are several factors that may play a role during the [migration] of patients and [in] their treatment by healthcare professionals. Therefore, the [migration] of a patient should be evaluated with regards to their health condition and medical treatment should take this into consideration. We believe that when health professionals (physicians) decide that it may be appropriate for them to work in another [county], they should have knowledge concerning [current issues] about the patient migration. In order for this to happen, a proper and comprehensive medical record should be developed. It is suggested that health professionals should use these medical records to evaluate [migration] issues, and as a way to take into consideration the patient migration.

Anonymous Patient Answer

What is the average age someone gets opioid abuse?

The average patient who has received care for an opioid use and abuse syndrome would be aged 25.0 years, and the median age of this patient would be 27 years of age. In contrast, the probability of these patients getting treated with prescription opioids or illicit drugs decreased when the mean age of the patient increased. This finding should help the physician to understand the complex and challenging decision-making that has to be made, not only for the patient, but also for those who wish to intervene in the treatment process.

Anonymous Patient Answer
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