CLINICAL TRIAL

Buprenorphine Injection for Syndrome

Recruiting · 18 - 65 · Female · Huntington, WV

Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study

See full description

About the trial for Syndrome

Eligible Conditions
Substance, Addiction · Pregnancy Related · Substance Abuse · Drug Abuse in Pregnancy · Substance Withdrawal Syndrome · Neonatal Abstinence Syndrome · Neonatal Opioid Withdrawal Syndrome · Substance-Related Disorders · Opioid-Related Disorders · Syndrome

Treatment Groups

This trial involves 2 different treatments. Buprenorphine Injection 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.
Buprenorphine Injection
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Buprenorphine Sublingual Product
DRUG

Eligibility

This trial is for female patients between 18 and 65 years old. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participating in the MOMs trial (Unique protocol ID: 2019-0429-1)
View All
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
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Delivery
Screening: ~3 weeks
Treatment: Varies
Reporting: Delivery
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Delivery.
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 Buprenorphine Injection will improve 5 primary outcomes in patients with Syndrome. Measurement will happen over the course of Delivery.

Concentration of buprenorphine and metabolites in cord plasma
DELIVERY
Cord blood will be collected and used to estimate fetal exposure to buprenorphine.
DELIVERY
Fetal heart rate variability
ESTIMATED GESTATIONAL AGE (EGA) APPROXIMATELY 36 WEEKS
This is the measure of primary interest from the fetal evaluation (non-stress test and biophysical profile).
ESTIMATED GESTATIONAL AGE (EGA) APPROXIMATELY 36 WEEKS
Concentration of buprenorphine and metabolites in maternal plasma
DELIVERY
A blood draw around the time of delivery to evaluate the association between drug concentration and neonatal opioid withdrawal syndrome outcomes.
DELIVERY
Cmax of buprenorphine and metabolites in plasma
ESTIMATED GESTATIONAL AGE (EGA) APPROXIMATELY 36 WEEKS
A blood draw at the estimated time of maximum drug concentration ("peak") to evaluate trough-to-peak fluctuation for the conceptual model.
ESTIMATED GESTATIONAL AGE (EGA) APPROXIMATELY 36 WEEKS
Cmin of buprenorphine and metabolites in plasma
ESTIMATED GESTATIONAL AGE (EGA) APPROXIMATELY 36 WEEKS
A blood draw at the estimated time of minimum drug concentration ("trough") to evaluate trough-to-peak fluctuation for the conceptual model.
ESTIMATED GESTATIONAL AGE (EGA) APPROXIMATELY 36 WEEKS

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 syndrome be cured?

For the diagnosis of mental disorders, a diagnostic classification system that is flexible and reliable is required. To reduce the influence of external factors and to ensure an accurate diagnosis, a multidisciplinary approach including psycho-social approaches is recommended.

Anonymous Patient Answer

How many people get syndrome a year in the United States?

Many people who had contact with a person with stomatitis get it every year, mostly from family members and non family caregivers. There are many ways to prevent the spread of disease, such as eliminating and eliminating transmission.

Anonymous Patient Answer

What are the signs of syndrome?

There is a considerable range of clinical and biological features that make it difficult to define a recognizable syndrome. A diagnosis should be based on physical and endocrine findings. The association of breast cancer with thyroid disease is known. Patients with the syndrome should be screened for breast cancer, as it has a high probability of being under-diagnosed. It should be remembered that in many cases endocrine disorders occur without compromising the health status as long as symptoms are not severe.

Anonymous Patient Answer

What causes syndrome?

The cause of all syndromes is unknown, but the risk of developing some is increased by underlying genetic predisposition, as for example in Turner's syndrome, and this risk can be further enhanced by exposure to adverse physical factors such as radiation, and by lifestyle choices such as smoking. However, there is much that we do not understand about the causes of complex diseases such as schizophrenia.

Anonymous Patient Answer

What is syndrome?

Syndromes are a series of characteristics associated with certain clinical circumstances or biochemical parameters. Such associations may represent a syndromic phenotype, as seen in the myopia, myotonic dystrophy type 1, X-linked mental retardation, and osteogenesis imperfecta spectrum, and also in certain endocrine and metabolic syndromes such as obesity, diabetes mellitus, and hypercholesterolemia.

Anonymous Patient Answer

What are common treatments for syndrome?

The management of HACE (Hereditary Angioedema, C1-Inhibitor Deficiency syndrome, Edema) is complicated and requires an interdisciplinary approach. Many physicians treating patients with this syndrome are unaccustomed to referrals from other specialties for consultation, diagnostics and therapy. A careful medical history, physical examination and laboratory testing may aid in the diagnosis. This requires that patients presenting with this syndrome be referred to specialists for testing and treatment of specific disorders.

Anonymous Patient Answer

Who should consider clinical trials for syndrome?

A significant number of trials were completed in different European countries despite the lack of a common consensus on its indications and procedures. In a recent study, findings showed that clinical trials in various syndromes could be improved in the EU by increasing transparency of methodological quality assurance and reporting and by setting up a consensus on indications. It also suggested criteria for participation in clinical trials that could simplify enrollment, and it can help investigators in choosing the right clinical trial in a given country and to provide guidance to patients.

Anonymous Patient Answer

Is buprenorphine injection safe for people?

Injection of low-dose BZD/MND with or without methadone may not pose major risk for developing BZD-associated problems such as respiratory depression, hypotension, and injection tolerance. In the United States, BZD is the only available treatment for persons with opioid-related addiction. In the United Kingdom, MND remains the most common opioid analog that is prescribed for opioid-dependent persons. There is an urgent need for effective treatment options for heroin or opiate-dependent persons.

Anonymous Patient Answer

Is buprenorphine injection typically used in combination with any other treatments?

In a sample of patients with opioid-related OST in residential settings in the United States, buprenorphine was most often used in combination with another medication. There was greater incidence of buprenorphine overdose in a sample of patients who overdosed compared to a sample of patients who did not overdose.

Anonymous Patient Answer

How serious can syndrome be?

Results from a recent paper suggest that the seriousness of an HPS may not be necessarily correlated with the severity of symptoms seen at presentation. Indeed, as in the current cohort, patients with symptomatic or asymptomatic HPS appear to have similar prognoses for overall survival and a lower risk of developing renal failure and heart failure than those with overt syndrome.

Anonymous Patient Answer

How does buprenorphine injection work?

The authors concluded that this is the first report to show that injection of buprenorphine by a route other than intramuscular (IM) injection can decrease withdrawal symptoms in opioid-dependent patients. The reduction of withdrawal symptoms suggested that buprenorphine injection might be a useful means of reducing substance use in opioid-dependent patients, whether they are on methadone or buprenorphine maintenance therapeutics.

Anonymous Patient Answer

What are the common side effects of buprenorphine injection?

Buprenorphine injection is one of the most common means used for the administration of sublingual or subcutaneous BZD treatment. With this frequency of use, a wide range of side effects has been observed that deserve attention. In a recent study, findings of this study have a significant effect on the clinical management of patients on buprenorphine.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Syndrome by sharing your contact details with the study coordinator.