What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder (OUD) include medications such as methadone, buprenorphine, and naltrexone. Methadone can cause side effects like constipation, sweating, and potential for dependency. Buprenorphine may lead to headaches, nausea, and sleep disturbances. Naltrexone can cause gastrointestinal issues, dizziness, and liver enzyme abnormalities. These treatments aim to reduce opioid cravings and withdrawal symptoms, thereby supporting recovery. In the context of the trial on overnight infant respite care and parenting skills, these treatments can help mothers manage their OUD more effectively, potentially reducing stress and improving caregiving abilities.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. Methadone is a long-acting opioid agonist that reduces withdrawal symptoms and cravings. Buprenorphine, a partial opioid agonist, helps to alleviate withdrawal symptoms and reduce cravings with a lower risk of misuse. Naltrexone, an opioid antagonist, blocks the euphoric effects of opioids and is used to prevent relapse. These medications are often used in combination with counseling and behavioral therapies to provide comprehensive treatment for individuals with OUD, similar to the supportive approach being studied in the trial involving overnight infant respite care and parenting skills for postpartum mothers with substance use disorders.

What other types of research exist?

Promising, novel alternatives to Overnight Infant Respite Care and Parenting Skills for OUD patients include: 1) Behavioral interventions for infant sleep problems, 2) Integrative health approaches such as acupuncture, 3) Use of probiotics for infant health, and 4) Comprehensive family support programs that offer holistic care including mental health support, substance use counseling, and parenting education.

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Night Respite Care for Postpartum Mothers with Substance Use Disorder

N/A

Recruiting

Led By Davida M Schiff, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through three months following intervention

Awards & highlights

Study Summary

This trial looks at overnight care for babies of moms with substance use disorder, in order to help them build parenting skills.

Who is the study for?

This trial is for mothers with substance use disorders who are the primary caretakers of an infant under 12 months, living in a residential treatment program. They must speak English or have limited proficiency and be diagnosed with a substance use disorder. Mothers with untreated serious mental health issues, active substance use, violence history, or unsafe home environments cannot join.Check my eligibility

What is being tested?

The study tests overnight infant respite care combined with parenting skills support for postpartum mothers with substance use disorders. It's a single-arm pilot study focusing on feasibility within residential treatment programs.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like night respite care and parenting education, traditional side effects associated with medications are not applicable. However, there may be emotional or psychological impacts from participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through three months following intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through three months following intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and through three months following intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recruitment and Enrollment

Study Acceptability

Study Feasibility

Secondary outcome measures

Ability to fall asleep

Filings for child abuse/neglect

Maternal mental health - Anxiety

+12 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Night Respite CareExperimental Treatment1 Intervention

18 overnight night respite care sessions over six weeks with parental skills provided through teachable moments before and after respite care supports

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Opioid Use Disorder (OUD) include pharmacological and psychosocial interventions. Medications like methadone, buprenorphine, and naltrexone work by interacting with opioid receptors in the brain to reduce cravings and withdrawal symptoms. Methadone and buprenorphine are opioid agonists that activate these receptors to a lesser degree, while naltrexone is an antagonist that blocks opioid effects. Psychosocial treatments, such as Cognitive Behavioral Therapy (CBT) and family therapy, focus on changing behaviors and thought patterns related to substance use. These combined approaches are essential for addressing both the physiological and psychological aspects of addiction, thereby improving the chances of long-term recovery. This is particularly relevant for programs like Overnight Infant Respite Care and Parenting Skills, which aim to reduce stress and enhance caregiving abilities, supporting the overall well-being of mothers with OUD.

Family in pediatric obesity management: a literature review.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,945 Previous Clinical Trials

13,203,843 Total Patients Enrolled

Davida M Schiff, MDPrincipal InvestigatorMassachusetts General Hospital

Media Library

Night Respite Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746507 — N/A

~9 spots leftby Dec 2024

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