Preconception Intervention for Substance Use Disorder

Overseen By Giulia Croce Butler, MA

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

Trial Summary

What is the purpose of this trial?

The goal of this pilot trial is to test the feasibility and acceptability as well as efficacy of the adapted intervention, CHOICES-PLEAS (Pregnancy Liberated from Exposure to Alcohol and Substances) among women will illicit polysubstance use participating in a court-mandated jail-based 90-day substance use disorder treatment program. The main questions it aims to answer are: 1. What is the feasibility and acceptability of implementing the CHOICES-PLEAS intervention in a court-mandated jail-based substance use disorder treatment program? 2. Does participation in CHOICES-PLEAS lower the risk of a substance exposed pregnancy at 1 and 3 months after release compared to a control condition? 3. Does participation in CHOICES-PLEAS increase motivation to change substance use and reduce risky sexual behaviors at 1 and 3 months after release compared to a control condition? Participants will receive three one-on-one motivational interviewing sessions and one family planning referral visit during incarceration and one booster session at 1 month after release from jail. Researchers will compare the CHOICES-PLEAS intervention to a control condition to see if participation in the intervention reduces risk of substance exposed pregnancy, increases motivation to change substance use, and reduces risk of risky sexual behaviors.

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 data supports the effectiveness of the treatment CHOICES-PLEAS for Substance Use Disorder?

The CHOICES intervention, which is part of CHOICES-PLEAS, has been shown to effectively reduce the risk of alcohol-exposed pregnancies by using motivational interviewing and cognitive-behavioral strategies to encourage women to reduce alcohol use and adopt effective contraception. This approach has been successful in various settings, including primary care and substance abuse treatment, suggesting its potential effectiveness for Substance Use Disorder. ^{1 2 3 4 5}

Is the CHOICES intervention generally safe for humans?

The CHOICES intervention, which includes counseling sessions to reduce alcohol use and improve contraceptive use, has been tested in various settings like primary care and substance abuse treatment centers. While the studies focus on effectiveness, they do not report any significant safety concerns, suggesting it is generally safe for participants. ^{1 2 3 4 6}

How is the CHOICES-PLEAS treatment different from other treatments for substance use disorder?

CHOICES-PLEAS is unique because it focuses on preconception intervention, using motivational interviewing and cognitive-behavioral strategies to reduce alcohol and substance use while promoting effective contraception, specifically to prevent substance-exposed pregnancies. ^{1 2 4 5 7}

Research Team

Jennifer R Bello Kottenstette, MD

Principal Investigator

St. Louis University

Eligibility Criteria

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.

I have used substances like heroin, fentanyl, or cocaine in the last 3 months.

English-speaking

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A novel integration effort to reduce the risk for alcohol-exposed pregnancy among women attending urban STD clinics. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Preventing Alcohol and Tobacco Exposed Pregnancies: CHOICES Plus in Primary Care. [2023]

3. England 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. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

CHOICES: an integrated behavioral intervention to prevent alcohol-exposed pregnancies among high-risk women in community settings. [2021]

5. United States 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Neonatal and maternal outcomes following maternal use of buprenorphine or methadone during pregnancy: findings of a retrospective audit. [2018]

7. Ireland pubmed.ncbi.nlm.nih.gov

Preconception health service provision among women with and without substance use disorders. [2022]