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Preconception Intervention for Substance Use Disorder
N/A
Recruiting
Led By Jennifer R Bello Kottenstette, MD
Research Sponsored by St. Louis University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one and three months after release from jail
Awards & highlights
Study Summary
This trial will test the efficacy of an intervention to reduce the risk of substance exposed pregnancies among women with substance use disorder.
Who is the study for?
This trial is for English-speaking women in jail who can get pregnant and have had unprotected sex with a male partner. They must have used substances like heroin, fentanyl, opioids, cocaine, methamphetamine, marijuana or alcohol combined with another substance in the three months before their arrest or treatment program.Check my eligibility
What is being tested?
The CHOICES-PLEAS intervention is being tested to see if it's feasible and acceptable in a court-mandated jail-based program. It aims to reduce the risk of pregnancies exposed to substances and encourage changes in substance use and sexual behavior after release from jail.See study design
What are the potential side effects?
Since this study involves motivational interviewing sessions rather than medication, there are no direct side effects like those seen with drugs. However, participants may experience emotional discomfort discussing sensitive topics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one and three months after release from jail
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one and three months after release from jail
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with a change in risk of substance exposed pregnancy compared to baseline using Timeline Followback method assessing substance use and risky sexual behaviors
Secondary outcome measures
Decisional balance to change contraception use
Decisional balance to change substance use
Readiness to change risky sexual behavior
+3 moreOther outcome measures
Feasibility of delivering the intervention in the 90-day substance use disorder treatment program
Participant acceptance of and satisfaction with the intervention
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CHOICES-PLEASExperimental Treatment1 Intervention
Participants in the experimental arm will receive the motivational interviewing intervention, CHOICES-PLEAS which consists of three one-on-one sessions and one family planning referral visit during incarceration and one booster session at one month after release from jail.
Group II: Control conditionActive Control1 Intervention
Participants in the active comparator will receive a control condition that consists of a booklet with general information about healthy lifestyle for women as well as a referral guide to local resources.
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Who is running the clinical trial?
St. Louis UniversityLead Sponsor
194 Previous Clinical Trials
43,565 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,641 Total Patients Enrolled
Jennifer R Bello Kottenstette, MDPrincipal InvestigatorSt. Louis University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot become pregnant (I am sterilized or use long-term birth control).I have had vaginal sex with a male partner in the last three years.I have used substances like heroin, fentanyl, or cocaine in the last 3 months.I have not had vaginal sex with a male partner in the last 3 years.I can become pregnant because I haven't had permanent sterilization or use long-term birth control.I do not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: CHOICES-PLEAS
- Group 2: Control condition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project presently recruiting participants?
"According to clinicaltrials.gov, recruitment for this specific trial is currently paused. The experiment was first posted on July 1st 2023 and the last update occurred on May 8th of that same year. Although there are no immediate opportunities here, 371 other medical trials presently seek volunteers."
Answered by AI
What are the prerequisites for participating in this medical research?
"Eligibility criteria for this trial includes a diagnosis of substance use disorder and an age between 18-44 years old. The research team is looking to enrol approximately 90 participants in total."
Answered by AI
Is this study open to participants eighteen years and older?
"This medical trial has an age range of 18 to 44 years old, meaning that patients need to be within this window in order to qualify for participation."
Answered by AI
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