CLINICAL TRIAL

High Intensity for Opioid Abuse

Recruiting · Any Age · All Sexes · Portland, OR

This study is evaluating whether a low- or high-intensity implementation strategy is more effective in supporting hospital-based opioid use disorder treatment.

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About the trial for Opioid Abuse

Eligible Conditions
Opioid-Related Disorders · Substance Use Disorders (SUD) · Disease · Opioid Use Disorder, Moderate · Opioid Use Disorder, Severe · Substance-Related Disorders

Treatment Groups

This trial involves 2 different treatments. High Intensity 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
High Intensity
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Low Intensity
OTHER

Eligibility

This trial is for patients born any sex of any age. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Commit to having buprenorphine-waivered prescribers willing and able to write prescriptions to bridge discharged patients to post-discharge OUD treatment, or available direct entry into outpatient MOUD with methadone or buprenorphine.
Have hospital staff who express willingness to engage with a site/hub team for training and for data collection.
Be a community hospital deemed by the lead investigators to be in the region of a site/hub. Region will usually be defined as state unless a compelling case can be made as to geographic feasibility of implementing the intervention and access to relevant Medicaid data.
Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.
Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge.
Be willing to be randomized to low-intensity or high-intensity implementation support.
Provide inpatient general medical care.
Have sufficient numbers of Medicaid OUD discharges (any listed diagnosis; sufficient is defined as at least enough such that when added to the other hospitals in the region there are on average 100 discharges per year). Medicaid data must capture at least 3 discharge diagnoses, outpatient MOUD, and be available within no more than 12 months of discharge.
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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: 34 days following hospital discharge
Screening: ~3 weeks
Treatment: Varies
Reporting: 34 days following hospital discharge
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 34 days following hospital discharge.
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 High Intensity will improve 1 primary outcome in patients with Opioid Abuse. Measurement will happen over the course of 34 days following hospital discharge.

Engagement with MOUD
34 DAYS FOLLOWING HOSPITAL DISCHARGE
measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention.
34 DAYS FOLLOWING HOSPITAL DISCHARGE

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 are the signs of opioid abuse?

Opioid use is associated with many symptoms common to the abuse of other psychoactive agents, such as anxiety, paranoia, dysphoria, depersonalization, irritability, restlessness, and craving.

Anonymous Patient Answer

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

There is a relatively high rate of illicit heroin and opioid abuse in most areas of the country. The highest figures may be due to the recent growth of heroin use in San Diego County, and the fact that such use is not detected. Furthermore, there is a high rate of abuse of prescription medication. Although the majority of abusers are men, it is evident that both sexes can be adversely affected by this issue. The high rates of abuse are difficult to explain and are of concern for those charged with the responsibility of caring for the public. Preventive measures include improved education and awareness and control of prescription opioid use.

Anonymous Patient Answer

What is opioid abuse?

Results from a recent paper suggest that addiction may not only be defined by the compulsive use of a substance but also by the persistent reward process. Therefore, it is necessary to prevent the risk of developing an addiction to an addictive substance before it is established.

Anonymous Patient Answer

What are common treatments for opioid abuse?

A significant number of individuals are prescribed a variety of medications for the management of opioid abuse. The use of antidepressants, selective serotonin reuptake inhibitors (SSRIs), and stimulants have been demonstrated in clinical studies on the use of prescription drugs to treat alcohol and cocaine use disorders. The use of these medications should be examined in a broader sample of individuals who take medicines to obtain a better understanding of the use of such agents in the general population. A number of medications may be used to treat opioid use disorders, but the role of each type of drug used is yet to be established.

Anonymous Patient Answer

What causes opioid abuse?

There is a lack of consensus on the true cause of alcohol and drug abuse and most theories about addiction are a product of the limitations of current knowledge and research. However, current theories have made significant advances in explaining the mechanism through which drugs are rewarding and/or addictive, which is still an important topic in relation to both the prevention and treatment of drug use and dependence.

Anonymous Patient Answer

Can opioid abuse be cured?

Even though patients are likely to continue to abuse opioids, there will be a shift in the population to non-opioid forms of abuse after successful treatment of opioid abuse. These non-opioid forms of abuse have been associated with a much reduced likelihood of chronicity of abuse. Opioid-positive patients, those with a history of opioid abuse, those who reported a lifetime history of a number of different types of abuse, and those who report having switched to nonprescription opioids are likely to continue to use opioids.

Anonymous Patient Answer

Has high intensity proven to be more effective than a placebo?

Although the overall high intensity group used more opioids than the control group, these results suggest that the placebo effect is a significant factor in the outcome of this treatment strategy.

Anonymous Patient Answer

What is the primary cause of opioid abuse?

In the United Kingdom, the leading cause of opioid abuse is prescription opiate dependence and treatment related pain. There were no significant differences between male and female subjects.

Anonymous Patient Answer

Does opioid abuse run in families?

Opioid-abusing adolescent siblings are more likely than non-abusing siblings to be the parent of their parent's opiate-using siblings than siblings without opioid abuse. In a recent study, findings suggest that drug-specific genetic risk does exist in the family, indicating the need to investigate gene-environment interactions with a genetic basis.

Anonymous Patient Answer

What is high intensity?

The use of high-intensity therapy for opioid addiction does not translate into fewer relapses, and relapse rates are comparable with that achieved with low- and intermediate-intensity therapy, if not actually greater. Therefore, in terms of effectiveness, we caution against the introduction of high-intensity therapy for opioid dependence. What differences might exist in treatment effectiveness between different high-intensity treatment approaches are unclear.

Anonymous Patient Answer

How serious can opioid abuse be?

Opioid abusers are at high risk for other kinds of harm. They are at risk for a variety of physical and psychological harms; the high level of comorbid medical problems found in our sample suggests that the health professionals involved in a drug rehabilitation treatment assignment must screen their patients for these concerns.

Anonymous Patient Answer

Who should consider clinical trials for opioid abuse?

Recent findings suggests that clinical trials for opioid use disorders should be targeted towards high-risk patients. Furthermore, the results also suggest that it is important to pay close attention to the number of trials and patients in addition to the risk-benefit ratio of the clinical trials.

Anonymous Patient Answer
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