WORTH Paths Digital Intervention for Substance Addiction

Overseen By Melissa N Slavin, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Fairleigh Dickinson University

Disqualifiers: Pregnancy, Infertility, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Women in the criminal legal system are more likely to experience substance use disorders and unintended pregnancy than women in the general public. However, they often face barriers to accessing substance use treatment and sexual and reproductive health services. This study tests the feasibility and acceptability of Women on the Road to Health (WORTH) Promoting Access to Treatment, Health, and Support (Paths), a digital intervention adapted from the evidence-based CDC Best Practice HIV prevention intervention, Women on the Road to Health (WORTH), originally developed at Columbia University School of Social Work. WORTH Paths is designed to help reproductive-aged women in the criminal legal system with substance use disorders and unmet need for contraception reduce drug use and improve contraceptive use. Participants (N=50) will be randomly assigned to one of two groups: WORTH Paths Intervention Group - Participants will attend three virtual group sessions with facilitated videoconference sessions and self-paced digital activities focused on reducing drug use and increasing contraceptive use. They will also receive guidance on how to access and navigate health services. Control Group - Participants will receive a virtual general wellness program that includes education on substance use and sexual and reproductive health but does not include skills-based training related to these topics. The focus will be on general wellness and stress reduction. Both groups will receive resources for substance use treatment and sexual and reproductive health services. Researchers will track changes in drug use and contraceptive use over three months. Participants will complete surveys and provide urine samples to confirm changes in drug use. Primary aims: Feasibility: Measured by session attendance, treatment completion, dropouts, and reasons for termination. Acceptability: Measured by participant ease of use, helpfulness, and satisfaction. Primary behavioral outcomes: Self-reported drug use confirmed by urine drug tests. Contraceptive use, including initiation and consistent use. Secondary behavioral outcome: Linkage to substance use disorder treatment (measured by appointments made and sessions attended).

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves tracking drug use, it's possible that some medication adjustments might be necessary. It's best to discuss your specific situation with the study team.

What data supports the effectiveness of the WORTH Paths Intervention treatment for substance addiction?

Research shows that digital interventions, like the WORTH Paths Intervention, can effectively help people with substance use disorders. Studies have found that digital therapies can increase abstinence (staying away from substances) and improve retention in treatment, meaning more people stick with their recovery programs. ^{1 2 3 4 5}

Is the WORTH Paths Digital Intervention for Substance Addiction safe for humans?

Digital interventions for substance use disorders, like the WORTH Paths Digital Intervention, have been studied and are generally considered safe for humans. They are designed to be accessible and engaging, and some have even been authorized by the FDA for treating substance use disorders. ^{1 2 3 4 6}

What makes the WORTH Paths Digital Intervention unique for treating substance addiction?

The WORTH Paths Digital Intervention is unique because it uses digital technology to deliver treatment, which can increase accessibility and convenience for users. Unlike traditional face-to-face therapy, this digital approach can be accessed via personal computers or smartphones, making it more flexible and potentially reaching a wider audience, including those in rural or under-resourced areas. ^{1 4 7 8 9}

Research Team

Melissa N Slavin, PhD

Principal Investigator

Fairleigh Dickinson University

Eligibility Criteria

This trial is for reproductive-aged women in the criminal legal system with substance use disorders and a need for contraception. They should be interested in reducing drug use and improving contraceptive use. Specific eligibility details are not provided, but typically participants must meet certain health criteria to join.

Inclusion Criteria

Past year criminal legal involvement (e.g., incarceration or community supervision)

Meets criteria for current substance use disorder (SUD) as defined by DSM-5 and assessed by the Mini-International Neuropsychiatric Interview (MINI)

Meets criteria for unmet need for contraception (capable of pregnancy, sexually active, does not want to become pregnant within the next year, but is currently not using contraception)

Exclusion Criteria

I am able to understand and consent to my treatment.

Currently pregnant or actively trying to conceive

I have been diagnosed with infertility due to menopause, tubal ligation, or hysterectomy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the WORTH Paths program, including three virtual group sessions and digital activities focused on reducing drug use and increasing contraceptive use.

3 weeks

3 virtual group sessions

Control

Participants receive a general wellness program with education on substance use and reproductive health, stress management, and mindfulness exercises.

3 weeks

3 virtual group sessions

Follow-up

Participants are monitored for changes in drug use and contraceptive use through surveys and urine tests.

3 months

Treatment Details

Interventions

• WORTH Paths Intervention

Trial Overview The WORTH Paths digital intervention aims to help women reduce drug use and increase contraceptive use through virtual group sessions, videoconferences, and self-paced activities. It's being compared to a control group receiving general wellness education without skills training.

Participant Groups

Group I: WORTH Paths Digital Intervention Group Experimental Treatment 1 Intervention

Participants will receive a culturally tailored program adapted for reproductive-aged women involved in the criminal legal system with substance use disorders and unmet contraceptive needs. The intervention consists of three facilitated group sessions over videoconference with digital interactive activities to support behavior change. Key components include: * Raising awareness about different contraceptive methods and substance use treatment options * Discussing personal motivations for reducing drug use and using contraception * Developing skills to identify and manage substance use and reproductive health triggers * Digital interactive activities to reinforce learning and skill-building * Practicing decision-making tools and goal-setting strategies * Addressing barriers related to safety including intimate partner violence * Creating a safety plan and strategies for maintaining progress * Resources for state and online substance use and sexual/reproductive health services

Group II: WORTH Paths Digital Wellness Group Active Control 1 Intervention

Participants in this arm will receive the WORTH Paths Wellness Group, a wellness-focused intervention delivered via three facilitated group sessions over videoconference with digital interactive activities. Sessions cover general health, stress reduction, and navigating health services. Topics include education about substance use and sexual and reproductive health risks, guided meditation and mindfulness training, stress management techniques, and an overview of substance use and reproductive health services. Participants will also receive digital wellness resources, including recorded mindfulness exercises and links to online platforms for health services.

Who Is Running the Clinical Trial?

Fairleigh Dickinson University

Lead Sponsor

Trials

1

Recruited

50+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study involving 602 patients with substance use disorders who used the reSET® digital therapeutic, there was a high engagement level, with a median of 33 out of 61 lessons completed and 52% of patients finishing all core modules.

The treatment showed promising outcomes, with a retention rate of 74% during the last four weeks and 62% of patients achieving abstinence by the end of the 12-week program, indicating the potential effectiveness of digital therapeutics in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. Xiong, X., Braun, S., Stitzer, M., et al.[2023]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

The National Drug Abuse Treatment Clinical Trials Network (CTN) has successfully integrated digital technologies into substance use disorder (SUD) research, leading to the first FDA-authorized 'prescription digital therapeutic' for SUD treatment, showcasing the efficacy of digital health tools.

CTN's research has also explored telehealth and digital screening methods to enhance SUD treatment accessibility, particularly in rural and underserved communities, indicating a promising direction for expanding care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of digital health to the assessment and treatment of substance use disorders: The past, current, and future role of the National Drug Abuse Treatment Clinical Trials Network. Marsch, LA., Campbell, A., Campbell, C., et al.[2021]

A digital therapeutic (DT) significantly increased abstinence rates among patients with substance use disorders (40.3% in the DT group vs. 17.6% in the treatment-as-usual group) over a 12-week period, indicating its efficacy in reducing substance use.

The DT also improved retention in treatment (76.2% vs. 63.2%), and importantly, there were no significant differences in adverse event rates between the DT and traditional treatment groups, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. Maricich, YA., Nunes, EV., Campbell, ANC., et al.[2022]

A study of 66 active cocaine users found that most participants reported regular Internet use, indicating that this population has similar rates of Internet access as the general public.

Younger individuals and those who use other drugs were more likely to be Internet users, suggesting that web-based interventions could be effectively targeted to reach cocaine users for treatment and research purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of internet access in active cocaine users. Strickland, JC., Wagner, FP., Stoops, WW., et al.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Effects of Digital Interventions to Support People in Recovery From Substance Use Disorders: Systematic Review. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

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

The application of digital health to the assessment and treatment of substance use disorders: The past, current, and future role of the National Drug Abuse Treatment Clinical Trials Network. [2021]

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

Safety and efficacy of a digital therapeutic for substance use disorder: Secondary analysis of data from a NIDA clinical trials network study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Digital interventions for substance use disorders in young people: rapid review. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Help for Substance Users (SU): A Systematic Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Profile of internet access in active cocaine users. [2018]

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

The effectiveness of electronic approaches to substance abuse prevention for adolescents. [2019]