Digital Program for Women with Opioid Use Disorder

Overseen By Dawn E. Sugarman, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mclean Hospital

Must be taking: Opioid treatment

Disqualifiers: Acute psychiatric, cognitive impairment, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new digital program designed specifically for women dealing with opioid use disorder. The study compares the usual treatment for opioid addiction with a version that includes this gender-specific digital intervention (GSDI). The goal is to determine if the digital program is user-friendly, satisfactory, and engaging for participants. Women diagnosed with opioid use disorder, who began medication treatment within the last 30 days and own a smartphone, might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research tailored specifically for women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It seems you can continue your medication treatment for opioid use disorder as usual.

What prior data suggests that this digital program is safe for women with opioid use disorder?

Research has shown that the digital program designed for women with opioid use disorder has not raised any specific safety concerns in past studies. These studies have primarily assessed the program's effectiveness rather than its safety.

As an online program, it is generally considered low-risk. It includes online lessons and mobile support, such as self-administered surveys and encouraging messages. These components are unlikely to cause harm, though limited solid data exists on any negative effects.

In summary, while specific safety data is lacking, the online nature of the program suggests it is likely safe and easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the gender-specific digital intervention (GSDI) for opioid use disorder because it offers a personalized approach tailored specifically for women. Unlike traditional treatments that rely solely on medication and therapy, GSDI incorporates a digital platform providing psychoeducation, relapse prevention skills, and motivational support. The combination of a web-based and mobile component ensures continuous engagement and self-monitoring, which could enhance adherence and improve outcomes. Additionally, the GSDI targets gender-specific challenges, potentially making it more effective for women compared to general treatment programs.

What evidence suggests that this digital program is effective for women with opioid use disorder?

Research has shown that digital programs can assist women with opioid addiction. These programs often address issues affecting women more than men, influencing treatment effectiveness. In this trial, participants will join one of two groups. One group will receive the gender-specific digital intervention (GSDI) alongside treatment as usual (TAU). The GSDI includes online learning and mobile support, aiming to improve self-care and help women adhere to their treatment plans. The other group will receive only the standard treatment as usual. Some studies suggest that combining digital tools with regular treatment might lead to better outcomes, such as medication adherence or relapse prevention. While more research is needed, early findings indicate these digital tools could be a promising addition to regular care. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for women over 18 with an opioid use disorder who have started medication treatment in the last 10 days. Participants must own a smartphone and be able to give informed consent.

Inclusion Criteria

Current opioid use disorder diagnosis

Have a smartphone

Able to provide informed consent

Exclusion Criteria

Admitted to their current treatment episode on an involuntary status

I do not have any mental health or cognitive issues that would stop me from following the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment-as-usual plus a gender-specific digital intervention or treatment-as-usual only

12 weeks

Weekly engagement with digital intervention

Follow-up

Participants are monitored for feasibility, satisfaction, and engagement with the intervention

12 weeks

Follow-up visits at 2, 6, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gender-specific digital intervention (GSDI)
• Treatment as usual

Trial Overview The study tests a gender-specific digital intervention (GSDI) alongside usual treatment for opioid use disorder versus usual treatment alone. It measures how well the digital tool works, how satisfied participants are, and their level of engagement.

How Is the Trial Designed?

Group I: Treatment as usual (TAU) Experimental Treatment 1 Intervention

TAU for opioid use disorder consists of a mix of medication treatment and individual and group therapy services across various levels of care: inpatient, residential, and outpatient. Residential treatment is for adults who have completed detoxification and require additional treatment in a structured environment. Inpatient treatment includes short-term care and detoxification treatment and incorporates a combination of group, family, and individual therapy targeted at medical stabilization, reducing the severity of the patient's symptoms, and providing resources and ongoing support to prevent relapse. Outpatient treatment is focused on comprehensive evaluation and stabilization.

Group II: Gender-specific digital intervention plus treatment as usual (GSDI+TAU) Experimental Treatment 2 Interventions

GSDI + TAU includes the addition of a gender-specific digital intervention (GSDI) to treatment as usual. The GSDI has a web-based component and a mobile component. The web-based portion of the GSDI includes: (1) gender-specific psychoeducation on substance use disorders, (2) specific education on opioid use disorder, including information about medication treatment for opioid use disorder, and (3) information on relapse-prevention skills. Participants complete the web-based portion immediately after completing baseline assessments. The mobile component includes three parts: (1) weekly self-report surveys of opioid and other substance use and medication adherence, (2) weekly skills-practice exercises, and (3) daily motivational messages encouraging self-care. Participants engage with the mobile component after completing the web-based portion until the end of the study (12 weeks).

Treatment as usual is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Nicotine Replacement Therapy (NRT) for:

• Smoking cessation

Approved in United States as Bupropion (Zyban) for:

• Smoking cessation

Approved in Canada as Varenicline (Chantix) for:

• Smoking cessation

Who Is Running the Clinical Trial?

Mclean Hospital

Lead Sponsor

Trials

221

Recruited

22,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A significant majority of individuals receiving medication treatment for opioid use disorder (93%) view cigarettes as very harmful, while 63% also see e-cigarettes as harmful, indicating a strong awareness of health risks associated with both.

Despite concerns about health harms, 65% of participants found e-cigarettes helpful for reducing or quitting cigarette use, suggesting potential acceptability as a harm reduction strategy among those in buprenorphine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of E-cigarettes among adults in treatment for opioid use disorder. Streck, JM., Regan, S., Kalkhoran, S., et al.[2023]

A study of 315 opioid dependent smokers revealed that 98.7% had heard of e-cigarettes, with 73.0% having tried them and 33.8% using them in the past month, indicating a high level of awareness and usage compared to the general population.

The primary motivations for using e-cigarettes included curiosity and the desire to quit nicotine, suggesting that e-cigs could be integrated into smoking cessation strategies for individuals with opioid dependence, although their optimal use as a cessation tool is still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-cigarette knowledge, attitudes, and use in opioid dependent smokers. Stein, MD., Caviness, CM., Grimone, K., et al.[2018]

Contingency management, an incentive-based treatment, showed the most promise for smoking cessation among pregnant women on buprenorphine or methadone, with 31% achieving abstinence in a 12-week study, compared to 0% in control groups.

Only three studies were found on smoking cessation treatments for this population, highlighting a significant gap in research and the need for more effective strategies to support pregnant women in medication-assisted treatment for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating tobacco use disorder in pregnant women in medication-assisted treatment for an opioid use disorder: a systematic review. Akerman, SC., Brunette, MF., Green, AI., et al.[2018]

A scoping review of 27 studies on digital health interventions for pregnant and early parenting women with substance use disorders (SUD) shows promising efficacy in supporting treatment, particularly for pregnant women, but highlights a lack of research for early parenting women.

Most studies did not involve family members or include pregnant and early parenting women in the design of interventions, indicating a need for future research to engage these women and their support systems in developing tailored digital solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Digital Technology to Support Pregnant and Early Parenting Women in Recovery from Addictive Substances: A Scoping Review. Raynor, P., Corbett, C., West, D., et al.[2023]

Smokers with opioid dependence have a higher severity of nicotine dependence compared to those without opioid dependence, as shown by data from a large national survey of 58,971 adult smokers.

Opioid-dependent smokers are approximately twice as likely to be nicotine dependent, indicating a need for tailored smoking cessation interventions for this vulnerable group to improve their chances of quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between opioid and nicotine dependence in nationally representative samples of United States adult daily smokers. Parker, MA., Streck, JM., Sigmon, SC.[2019]

Opioid-dependent smokers experience higher baseline tobacco withdrawal symptoms compared to smokers without substance use disorders, but both groups show similar reductions in withdrawal symptoms during a 2-week abstinence period.

Despite the initial higher withdrawal scores, the study found no significant differences in withdrawal severity between opioid-dependent and non-substance use disorder smokers during verified smoking abstinence, indicating that withdrawal may not be the primary reason for the low quit rates in opioid-dependent individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco withdrawal among opioid-dependent smokers. Streck, JM., Heil, SH., Higgins, ST., et al.[2023]

A study involving 20 hospitalized individuals with opioid use disorder (OUD) found that 60% were interested in receiving text messages to help them quit smoking, indicating a strong potential for mobile health interventions in this population.

Participants rated messages about the health benefits of quitting smoking as the most motivating, suggesting that a text message program could effectively support smoking cessation efforts among individuals with OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text-messaging to promote smoking cessation among individuals with opioid use disorder: quantitative and qualitative evaluation. Shankar, D., Borrelli, B., Cobb, V., et al.[2022]

The extended innovative system intervention (E-ISI) successfully increased motivation to quit smoking among patients receiving buprenorphine-assisted therapy, with 54% of participants engaging in the extended treatment.

Despite increased motivation and quit attempts, the E-ISI did not lead to higher long-term cigarette abstinence rates compared to standard treatment, indicating a need for more innovative smoking cessation strategies for patients with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cigarette Smoking Cessation Intervention for Buprenorphine Treatment Patients. Hall, SM., Humfleet, GL., Gasper, JJ., et al.[2020]

Among 319 opioid-dependent patients treated with buprenorphine, a significant 67.4% were current smokers, highlighting a high prevalence of tobacco use in this population.

Only 16.8% of current smokers received smoking cessation prescriptions, indicating a missed opportunity to provide effective cessation treatment alongside opioid dependency treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation treatment among office-based buprenorphine treatment patients. Nahvi, S., Blackstock, O., Sohler, NL., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05776966

NCT05776966 | Women's Opioid Treatment Follow-up Study The GSDI is a digital intervention that incorporates factors that are more prevalent in women with opioid use disorder that may affect their treatment outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11376107/

Digital health interventions to support women with opioid use ... Of 11 studies focused on OUD treatment, only three reported outcomes related to MOUD utilization. Two studies described community engagement to inform the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624002746

Digital health interventions to support women with opioid ... Of 11 studies focused on OUD treatment, only three reported outcomes related to MOUD utilization. Two studies described community engagement ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38861765/

Digital health interventions to support women with opioid use ... Of 11 studies focused on OUD treatment, only three reported outcomes related to MOUD utilization. Two studies described community engagement ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875924002996

Just an unfair score: Perceptions of gender inequity in the ... This study uses semi-structured interviews (N = 42) administered in 2022 to women with a history of SUD and criminal legal involvement.

6. withpower.com withpower.com/trial/digital-program-for-women-with-opioid-use-disorder-4dc90

Digital Program for Women with Opioid Use Disorder The research articles reviewed do not provide specific safety data for the digital program or similar interventions for women with opioid use disorder. They ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06545071

Autonomous Digital CBT Intervention for Opioid Use ... These data include demographics, such as age, sex/gender, race and ... interventions on biomedical or health-related outcomes. The assignments are ...