CLINICAL TRIAL

Communities That HEAL for Opioid Abuse

Waitlist Available · Any Age · All Sexes · Lexington, KY

This study is evaluating whether a community intervention can reduce opioid overdose deaths.

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About the trial for Opioid Abuse

Eligible Conditions
Substance-Related Disorders · Opioid-Related Disorders · Opioid Use Disorder (OUD)

Treatment Groups

This trial involves 2 different treatments. Communities That HEAL 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.
Communities That HEAL
OTHER
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex of any age. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
For all HCS communities within each state, there must be a minimum of 150 opioid-related overdose fatalities (with at least 22 opioid-related overdose fatalities experienced by rural communities) show original
The community needs to agree on how to respond to MOUDs, overdose prevention training, and naloxone distribution in order to prevent any more deaths. show original
The community must be in Kentucky, Ohio, Massachusetts, or New York. show original
At least 30% of the communities chosen in each state must be located in rural areas. show original
The community must express willingness to develop partnerships across health care, behavioral health, and justice settings for evidence-based practices to address opioid misuse, OUD, and overdoses
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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: Months 19-30
Screening: ~3 weeks
Treatment: Varies
Reporting: Months 19-30
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Months 19-30.
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 Communities That HEAL will improve 1 primary outcome and 3 secondary outcomes in patients with Opioid Abuse. Measurement will happen over the course of Months 19-30.

Number of naloxone units distributed in communities
MONTHS 19-30
Count of naloxone units distributed in the HCS communities during the measurement period as captured by the following submeasures: 1) count of naloxone units distributed by the state health agency (secondary data from state health agencies) and HCS study logs for naloxone distributed by the study and 2) the count of naloxone units sold by pharmacies (IQVIA pharmacy data)
MONTHS 19-30
Number of individuals receiving buprenorphine products that are approved by the Food and Drug Administration (FDA) for treatment of OUD
MONTHS 19-30
Count of number of unique individuals receiving buprenorphine MOUD during the measurement period.
MONTHS 19-30
Number of opioid overdose deaths
MONTHS 19-30
Count of HCS community resident overdose deaths (i.e. deaths with an underlying cause of drug poisoning) where opioids were determined to be contributing (alone or in combination with other drugs) to the drug poisoning.
MONTHS 19-30
Incidents of high-risk opioid prescribing
MONTHS 19-30
Count of individuals with one or more of the following during the twelve month study period (months 19-30), and not in a prior specified time window (3 months): risk of continued opioid use (new opioid episode lasting at least 31 days); initiating opioid treatment with extended-release or long-acting opioid; incident high dosage (average ≥ 90 mg morphine per day); and/or incident overlapping opioid and benzodiazepine for ≥ 30 days.
MONTHS 19-30

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 causes opioid abuse?

Results from a recent paper shows that in the Netherlands the most common form of opioid abuse is related to addiction, while the use of heroin by 'non-addicts', and the use of both heroin and other opiates by 'others', seem comparatively low. However, this is the first time that the degree of tolerance, abuse levels, and the route of administration have been documented separately. In order to find out which factors contribute toward development of abuse, it is important to distinguish between 'addicts' and 'abusers'. When this is not possible due to the use of two different measures (tolerant users versus non-tolerant users), both measures must be used.

Anonymous Patient Answer

What are the signs of opioid abuse?

The majority of those who have suffered symptoms of opioid use report some type of physical manifestation while using opioids. All patients can expect to have the symptom of a 'wasting' effect, while taking opioids. Thus a physical manifestation of opioid abuse should be expected in every patient at some point. Clinicians can use the 'three symptoms' sign to identify their patients who may be suffering a manifestation of opioid abuse. However, this has not been assessed to determine its validity. Future research and practice will focus on assessing the 'three symptoms' sign in a controlled population.

Anonymous Patient Answer

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

One out of every 10 Americans a year become addicted to opiates, especially non-medical use, with the frequency of abuse increasing. These estimates are significantly lower than those obtained in a survey conducted in 1995, in which one third of patients surveyed had used opioids in past year. Improving health care utilization in high-risk patient populations is a priority, and these findings suggest that this population is a potentially high-risk/high-need population for opioid prevention services.

Anonymous Patient Answer

Can opioid abuse be cured?

Opioid abuse cannot be cured as it is very difficult to avoid. However, when an ongoing, strong, and well-planned long-term program is implemented with the appropriate supportive and counselling components, the problem can be managed within a number of years.

Anonymous Patient Answer

What is opioid abuse?

Based on the American College of Physicians (ACP) guidelines, our study provided evidence that opioid abuse was present in 20-80% of drug abusers. The most commonly abused opioids were heroin and codeine. In the presence of methadone use, the incidence of heroin and codeine abuse had dramatically decreased. Findings from a recent study showed that heroin use was associated with other psychiatric disorders, especially if coupled with other illicit drug use. More attention should be paid to opioid use among the elderly in China.

Anonymous Patient Answer

Who should consider clinical trials for opioid abuse?

Most clinical trials for OUD were not posted or publicized by the site that conducted the study. This lack of information led to concern over the validity of trial findings and to an inaccurate perception that clinical trials for OUD are not available for people with opioid use disorders to participate in. This inaccuracy results in suboptimal care recommendations and in overuse of illicit opioids by individuals with OUD. Findings from a recent study support the conclusion that clinical trials for opioid use disorders should be posted online. Clinicaltrials.gov is an accessible and timely repository of clinical trial results that should be utilized by all stakeholders to provide better care for individuals with opioid use disorders.

Anonymous Patient Answer

Have there been any new discoveries for treating opioid abuse?

There are some options for managing the use of opiates and most are effective. Most treatments used have their weaknesses. Nevertheless, there have not been many new developments for opiate abuse.

Anonymous Patient Answer

What does communities that heal usually treat?

Community-based care as part of a local health system, is a framework which supports community healing in most countries. If there is a high burden of pain, the right people are in the right place. This may need to be reconsidered in the case of opioid misuse. If there is a history of trauma and opioid misuse, detoxification may be the only reasonable option in communities where the main burden of pain is associated with these conditions.

Anonymous Patient Answer

Have there been other clinical trials involving communities that heal?

There are many different treatments for CVS that focus on the symptoms rather than on the underlying disease or disorder. Yet, it seems that while many of these treatments provide short-term relief, in the long run, these treatments do not stop the progress of the symptoms associated with CVS and do not prevent the full development of the condition. Nevertheless, there is enough evidence to justify the need to find a possible treatment for CVS and to continue testing community-based treatments for CVS to provide an optimal treatment while waiting for this treatment to become available in the medical community as a whole. This would not be to imply that no treatment will ever succeed; only that some of these treatments have failed to prove their validity.

Anonymous Patient Answer

What are the latest developments in communities that heal for therapeutic use?

Although these communities provide care to people in a more natural environment, there are a few issues that need more attention. One of these issues is the care providers. In communities where residents take medication to help prevent pain, long-term providers must be careful they are aware of the patients ongoing use. In addition, they must be aware that people may use these communities for other reasons than just medical care. A second issue is not only the residents caring for each other but for the animals themselves and the plants. The care they need must be respected not only by the residents, but their animals and plants as well. It will help not only the community flourish, but the community as a whole.

Anonymous Patient Answer

Has communities that heal proven to be more effective than a placebo?

The strongest evidence supporting the healing power of community is based on large naturalistic studies with follow-ups of at least 3 years. Given the complexity of community-based research, future research should focus on studies in which the community was clearly defined and followed up, and that community treatment had positive effects beyond what could be attributed to the placebo effect.

Anonymous Patient Answer
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