What side effects are associated with this type of intervention?

Common treatments for Substance Use Disorder (SUD) include medications like topiramate and varenicline. Topiramate can cause side effects such as impaired concentration, confusion, dizziness, anxiety, and paresthesias. Varenicline, used for smoking cessation and potentially effective for cannabis use disorder, may lead to nausea, sleep disturbances, and abnormal dreams. Medication-assisted treatments for opioid addiction, such as methadone and buprenorphine, can cause constipation, sweating, and potential dependency. These side effects are important considerations for women with SUD, especially in the postpartum period.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Substance Use Disorder (SUD). These include buprenorphine, methadone, and naltrexone, which are commonly used for opioid dependence. Buprenorphine and methadone are opioid agonists that help reduce withdrawal symptoms and cravings, while naltrexone is an opioid antagonist that blocks the effects of opioids. Additionally, varenicline, a selective nicotinic acetylcholine receptor agonist, has shown promise in treating cannabis use disorder. These medications are often used in conjunction with behavioral therapies to improve treatment outcomes.

What other types of research exist?

Promising alternatives to MyPath for contraceptive decision-making among SUD patients include: 1) Digital health platforms that integrate reproductive health and SUD management, offering personalized counseling and follow-up care. 2) Mobile health applications that provide real-time support and resources for contraceptive choices and SUD treatment. 3) Telehealth services that offer remote access to reproductive health specialists and SUD counselors, ensuring continuous and comprehensive care. These tools leverage technology to enhance accessibility, personalization, and support for SUD patients.

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MyPath Intervention for Postpartum Birth Control Planning in Women with Substance Use Disorder (IMPACT Trial)

N/A

Recruiting

Led By Elizabeth Krans, MD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

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

Must have

Newly postpartum women 18 years old+

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment (24 - 37 weeks pregnant) to 18 months post delivery

Awards & highlights

No Placebo-Only Group

Summary

This trial tests MyPath, a tool designed to help women with substance use disorders make better decisions about birth control after giving birth. MyPath helps women think about their plans for more children, learn about their health, and choose the best birth control method for them. The goal is to improve their reproductive health outcomes by aligning contraceptive choices with their personal goals.

Who is the study for?

This trial is for new mothers aged 18 or older who have just given birth at Magee-Womens Hospital, speak English, and meet the criteria for substance use disorder as confirmed by medical records or urine tests. Women with fetal or neonatal death, severe psychiatric conditions requiring urgent treatment, or non-DSM-V level substance use are excluded.

What is being tested?

The study is testing MyPath, a new tool designed to help postpartum women with substance use disorders make decisions about birth control. It will be compared to the usual care these women receive to see if it makes a difference in their contraceptive choices.

What are the potential side effects?

Since this trial involves a decision support tool rather than medication, there are no direct side effects from interventions like drugs. However, participation may influence personal decision-making regarding reproductive planning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a new mother and I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment (24 - 37 weeks pregnant) to 18 months post delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment (24 - 37 weeks pregnant) to 18 months post delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment (24 - 37 weeks pregnant) to 18 months post delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Continuous contraceptive use

Contraceptive method continuation

Secondary study objectives

Decisional Conflict

Interpregnancy interval

Involvement

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MyPath InterventionExperimental Treatment1 Intervention

At the first visit participants randomized to this arm receive MyPath contraceptive decision tool.

Group II: Standard of CareActive Control1 Intervention

At the first visit participants randomized to this arm receive standard of care contraceptive counseling.

0 / 1Eligibility criteria met

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

Common treatments for Substance Use Disorder (SUD) include Cognitive-Behavioral Therapy (CBT), Motivational Interviewing (MI), and Behavioral Couples Therapy (BCT). CBT helps patients identify and modify negative thought patterns and behaviors associated with substance use. MI enhances intrinsic motivation to change by resolving ambivalence. BCT involves the patient's significant other to improve relationship dynamics that support recovery. These treatments are crucial as they address both the psychological and social aspects of SUD, promoting sustained recovery and improving overall quality of life.

2016 United Kingdom national guideline on the sexual health care of men who have sex with men.Relationship between drug treatment services, retention, and outcomes.An emerging problem: methamphetamine abuse among treatment seeking youth.