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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital program called the WORTH Paths Intervention, designed to assist women involved in the criminal justice system who struggle with substance use and need better access to contraception. Participants will join one of two groups: one group will engage in sessions focused on reducing drug use and improving contraceptive use, while the other will focus on general wellness and stress reduction. Researchers will track changes in drug and contraceptive use over three months. Women who have been involved with the criminal legal system in the past year, have a substance use disorder, and need contraception but aren't currently using it might be a good fit. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance support systems for women facing similar challenges.

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 prior data suggests that the WORTH Paths digital intervention is safe?

Research has shown that digital tools for treating substance use disorders are generally safe and easy to use. Studies have found that these tools can help individuals reduce substance use and remain engaged in their treatment. Tools like the one tested in the WORTH Paths study typically include interactive activities and online support sessions.

Although specific safety data for the WORTH Paths tool is not yet available, other similar digital tools have not reported any serious side effects, suggesting they are safe for participants. These tools primarily focus on providing education and support, which are low-risk activities.

Overall, digital tools are gaining popularity because they offer a safe way to help manage substance use disorders. They provide a convenient option for those who might have difficulty accessing traditional treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WORTH Paths Digital Intervention for substance addiction because it offers a culturally tailored program specifically for reproductive-aged women involved in the criminal legal system. Unlike standard treatments that primarily focus on either substance use or reproductive health, this intervention integrates both, providing education on contraceptive methods and substance use treatment options simultaneously. Moreover, it uses a digital platform to deliver facilitated group sessions, making it accessible and flexible for participants who might face barriers to attending in-person sessions. This approach also emphasizes personal safety, addressing intimate partner violence and creating safety plans, which is not typically a focus in conventional treatments.

What evidence suggests that the WORTH Paths digital intervention is effective for substance addiction and contraceptive use?

Research has shown that digital tools can aid in treating substance use problems. Programs like WORTH Paths, for example, can enhance treatment outcomes and support behavioral changes. In this trial, participants in the WORTH Paths Digital Intervention Group will receive a culturally tailored program that focuses on personal motivations and teaches skills to manage triggers, aiming to reduce drug use and improve contraceptive use. Meanwhile, the WORTH Paths Digital Wellness Group will concentrate on general health, stress reduction, and navigating health services. Studies have found that digital cognitive behavioral therapy can reduce heavy drinking. Additionally, integrating technology with traditional treatments can enhance recovery. ^{3 4 5 6 7}

Who Is on the Research Team?

Melissa N Slavin, PhD

Principal Investigator

Fairleigh Dickinson University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. humanfactors.jmir.org humanfactors.jmir.org/2023/1/e46678/

Optimizing Digital Tools for the Field of Substance Use and ... Identifying factors associated with user retention and outcomes of a digital intervention for substance use disorder: a retrospective analysis ...

2. library.samhsa.gov library.samhsa.gov/sites/default/files/pep23-06-00-001.pdf

Digital Therapeutics for Management and Treatment in ... Areas for future research include the impact of DTx in the prevention of mental health conditions and substance use disorders, the safety and effectiveness.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2452310020300081

Digital health and addiction A robust and growing line of research has examined how digital health may enhance our understanding and treatment of addiction.

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1233888/full

Digital interventions targeting excessive substance use ... Digital cognitive behavioral therapy for alcohol has been shown to be effective in comparison with minimal control intervention (g = 0.20: 95% ...

5. recoveryanswers.org recoveryanswers.org/research-post/contingency-management-app-exploring-feasibility-automated-digital-contingency-management-substance-use-disorder/

Technology-enhanced contingency management Leveraging digital tools for substance use treatment may be able to complement formal treatment and improve individual recovery-related outcomes. Studies show ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8666102/

Safety and efficacy of a prescription digital therapeutic as ... The objective of this study was to further evaluate the efficacy of the PDT in treatment-seeking individuals with OUD by analyzing abstinence data in the last ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/08897077.2022.2060425

Safety and efficacy of a digital therapeutic for substance ... The results demonstrate that use of a DT safely increased abstinence (reduced substance use) and retention in treatment among patients with substance use ...