Preconception Intervention for Substance Use Disorder

Recruiting at 1 trial location

Overseen By Phebe Madhusudanan, MD, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: St. Louis University

Disqualifiers: Non-English-speaking, Not capable of pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help women in a court-mandated jail-based treatment program reduce substance use and risky behavior before pregnancy. Participants receive personalized sessions to motivate change and plan for family needs. The study compares this program, called CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances), to a simple information booklet to determine which is more effective at reducing substance-exposed pregnancies and increasing motivation to avoid substance use. Women who can become pregnant, speak English, and have used substances like heroin or meth in the past three months might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in preventing substance-exposed pregnancies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves substance use disorder treatment, it's possible that changes to medication might be required. Please consult with the trial coordinators for specific guidance.

What prior data suggests that the CHOICES-PLEAS intervention is safe?

Research has shown that the CHOICES program, on which CHOICES-PLEAS is based, has been tested in various settings with positive safety outcomes. One study found that 68.5% of women participating in the CHOICES program reduced their risk of alcohol-exposed pregnancies six months later. These studies reported no major negative effects, suggesting the approach is well-tolerated.

CHOICES-PLEAS, like CHOICES, employs motivational interviewing, a counseling method that encourages positive change. It avoids medications, often resulting in fewer side effects. The program focuses on reducing substance use and improving health habits, which can enhance overall well-being.

Although specific safety data for CHOICES-PLEAS is not yet available, the program's foundation has demonstrated safety in similar contexts. Participants generally report positive experiences with such programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHOICES-PLEAS intervention because it offers a unique, personalized approach to addressing substance use disorder (SUD) in women before pregnancy. Unlike traditional treatments that often focus on broad lifestyle changes or medication-based interventions, CHOICES-PLEAS uses motivational interviewing, providing one-on-one sessions to empower women with tailored support during incarceration and after release. This method not only targets substance use but also includes family planning referrals, aiming to create a supportive environment for women to make informed decisions about their health and future pregnancies. The combination of personalized counseling and practical resources makes CHOICES-PLEAS a promising new approach for women with SUD.

What evidence suggests that the CHOICES-PLEAS intervention is effective for reducing substance use and risky behaviors?

Research has shown that the CHOICES program, which participants in this trial may receive, can help reduce pregnancies exposed to alcohol among women at high risk. This program has been promising in helping women use birth control more effectively and drink less alcohol. Studies have found that women in the CHOICES program are more likely to adopt safer habits that lower the risk of pregnancies affected by substances. The program uses motivational interviewing, a method that encourages people to change unhealthy behaviors. While this trial focuses on women in a jail-based treatment program, the strategies have also worked well in other high-risk groups. ^{1 3 5 6 7}

Who Is on the Research Team?

Jennifer R Bello Kottenstette, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had vaginal sex with a male partner in the last three years.

English-speaking

I can become pregnant because I haven't had permanent sterilization or use long-term birth control.

Exclusion Criteria

I cannot become pregnant (I am sterilized or use long-term birth control).

No use of an illicit substance, such as only alcohol or marijuana use not in combination with another substance

Participated in a focus group that was part of the formative work for this study to create the intervention adaptation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive the CHOICES-PLEAS intervention, including three motivational interviewing sessions and a family planning referral during a 90-day jail-based substance use disorder treatment program

12 weeks

3 visits (in-person)

Booster Session

Participants in the intervention group receive a one-on-one motivational interviewing booster session at 1 month post-release

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in substance use and risky sexual behaviors at 1 and 3 months post-release

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances)

Trial Overview 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.

How Is the Trial Designed?

Group I: CHOICES-PLEAS Experimental Treatment 1 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 condition Active Control 1 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.

CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) is already approved in United States for the following indications:

Approved in United States as CHOICES-PLEAS for:

• Substance use disorder treatment
• Prevention of substance-exposed pregnancy

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials

197

Recruited

41,400+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Project CHOICES is an effective intervention designed to reduce the risk of alcohol-exposed pregnancy by addressing both alcohol consumption and contraceptive use among women visiting STD clinics.

The program utilizes motivational interviewing and personalized feedback, aligning with CDC strategies to integrate services and improve health outcomes for women at high risk of heavy alcohol use and ineffective contraception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel integration effort to reduce the risk for alcohol-exposed pregnancy among women attending urban STD clinics. Hutton, HE., Chander, G., Green, PP., et al.[2021]

The Project Healthy CHOICES study found that college students at risk of alcohol-exposed pregnancies (AEPs) were significantly more likely (68%) to not be at risk compared to nonstudents (46%) after a 6-month follow-up, primarily due to effective contraception use.

Both the motivational feedback and information-only interventions did not show significant differences in outcomes, indicating that simply informing women about the risks of AEPs can be an effective public health strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Alcohol-Exposed Pregnancies: A Randomized Controlled Trial of a Self-Administered Version of Project CHOICES with College Students and Nonstudents. Sobell, LC., Sobell, MB., Johnson, K., et al.[2018]

The CHOICES intervention effectively reduces prenatal alcohol exposure among high-risk women by combining motivational interviewing and cognitive-behavioral strategies, as demonstrated in various randomized controlled trials across multiple settings.

The program includes four counseling sessions and a contraceptive session, focusing on promoting effective contraception and reducing alcohol use, which has shown promising results in preventing alcohol-exposed pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CHOICES: an integrated behavioral intervention to prevent alcohol-exposed pregnancies among high-risk women in community settings. Velasquez, MM., von Sternberg, K., Parrish, DE.[2021]

In a study of 2,672 women of childbearing age, 17.4% were identified as at risk for nicotine-exposed pregnancies (NEP), highlighting a significant public health concern that parallels the risk of alcohol-exposed pregnancies (AEP).

The analysis revealed that women at risk for unplanned pregnancies often faced both AEP and NEP risks simultaneously, suggesting that preconception counseling programs could effectively address both issues together, especially for those with additional risk factors like substance use and lower education levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and factors associated with the risk of a nicotine exposed pregnancy: expanding the CHOICES preconception counseling model to tobacco. Parrish, DE., von Sternberg, K., Velasquez, MM., et al.[2022]

The CHOICES Plus intervention significantly reduced the risk of alcohol- and tobacco-exposed pregnancies (AEPs and TEPs) among women, with a 38% reduction in AEP risk and a 40% reduction in TEP risk compared to the Brief Advice group over a 9-month follow-up period.

This study, involving 261 women in a low-income primary care setting, demonstrates that addressing alcohol and tobacco use before pregnancy can effectively prevent substance-exposed pregnancies, shifting the focus from treatment to prevention in public health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing Alcohol and Tobacco Exposed Pregnancies: CHOICES Plus in Primary Care. Velasquez, MM., von Sternberg, KL., Floyd, RL., et al.[2023]

In a study of 52,565 women aged 18-55 who delivered between 2012 and 2018, only 6.0% received preconception services, highlighting a significant gap in care for both women with and without substance use disorders (SUD).

Women with SUD were more likely to receive preconception services (9.6%) compared to those without SUD (5.7%), but this association diminished when considering psychiatric comorbidities, suggesting that addressing mental health may be crucial in improving access to preconception care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception health service provision among women with and without substance use disorders. Bello, JK., Salas, J., Grucza, R.[2022]

In a study of 98 women on pharmacotherapy (methadone or buprenorphine) during pregnancy, a significant 24% of infants born at or after 33 weeks required medication for withdrawal symptoms, highlighting the potential risks associated with substance use in pregnancy.

The study found no significant difference in withdrawal medication requirements between mothers who used multiple substances and those who did not, indicating that polysubstance use may not increase the risk of withdrawal in infants, although the small sample size warrants caution in interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal and maternal outcomes following maternal use of buprenorphine or methadone during pregnancy: findings of a retrospective audit. Blandthorn, J., Forster, DA., Love, V.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4661109/

Development and Implementation of CHOICES Group to ... Development and Implementation of CHOICES Group to Reduce Drinking, Improve Contraception, and Prevent Alcohol-Exposed Pregnancies in American Indian Women.

2. researchgate.net researchgate.net/publication/237015681_CHOICES_An_Integrated_Behavioral_Intervention_to_Prevent_Alcohol-Exposed_Pregnancies_among_High-Risk_Women_in_Community_Settings

CHOICES: An Integrated Behavioral Intervention to Prevent ... CHOICES is an integrated behavioral intervention for prevention of prenatal alcohol exposure in women at high risk for alcohol-exposed ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547220303019

Women with a substance use disorder: Treatment ... Findings suggest that pregnant women, compared to similarly situated nonpregnant women, are significantly less likely to complete substance use treatment.

4. health.state.mn.us health.state.mn.us/people/womeninfants/womenshealth/tfpsud/preghealth.pdf

Task Force on Pregnancy Health and Substance Use ... According to a World Health Organization survey of fourteen countries, SUD and alcohol use disorder are respectively the number one and four ...

5. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2821473

Health Care Needs and Costs for Children Exposed to ... This cohort study assesses associations among substance use during pregnancy, health care needs among children, and out-of-home care.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5378586/

Impact of the CHOICES intervention in preventing alcohol ... A total of 193 non-pregnant American Indian women enrolled in the OST CHOICES Program, and all were at-risk for AEP because of binge drinking and being at-risk ...

7. astho.org astho.org/communications/blog/states-aim-improve-outcomes-for-people-experiencing-sud-pregnancy/

States Aim to Improve Outcomes for People Experiencing ... State legislators can help improve maternal health outcomes by recognizing SUD as a significant cause of pregnancy-associated death.