Mobile Therapy for Stimulant Use Disorder in HIV

(COSTA Trial)

Overseen By Jose Szapocznik, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Must be taking: Antiretrovirals

Disqualifiers: Cognitive impairment, Severe psychiatric symptoms, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called reSET to determine its effectiveness in treating stimulant use disorder in men who have sex with men and are living with HIV. The researchers aim to assess whether the app can help manage stimulant use and maintain HIV control. Participants will either use the app or continue their usual treatment methods for 12 weeks. The trial seeks men who are HIV-positive, have a stimulant use disorder, and are patients at specific clinics in Atlanta, Dallas/Fort Worth, Fort Lauderdale, or Los Angeles. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to have an active Antiretroviral Therapy prescription, so you should continue taking your HIV medication.

What prior data suggests that the reSET mobile therapeutic is safe for treating stimulant use disorder in men with HIV?

Research has shown that the reSET mobile app is safe for treating substance use disorders. The FDA has approved it, confirming its safety. In studies, 40.3% of patients using reSET successfully abstained from substances, indicating the app's effectiveness without causing major harm.

While most people use the app without issues, it is important to monitor any personal reactions or changes in feelings. As with any treatment, consulting a healthcare provider is advisable if concerns arise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stimulant use disorder in individuals with HIV include behavioral therapies and medications like bupropion or naltrexone. However, the reSET app offers a fresh approach by delivering therapy through a mobile platform, which makes it accessible anytime and anywhere. Researchers are excited about reSET because it provides cognitive behavioral therapy in a convenient, digital format, potentially enhancing engagement and adherence compared to traditional methods. This innovative delivery method could make treatment more personalized and adaptable to individual needs, paving the way for improved outcomes.

What evidence suggests that reSET is effective for treating stimulant use disorder in men with HIV?

Research shows that reSET, a mobile app, can help treat substance use disorder (SUD), including issues with stimulant use. Participants in this trial will join one of two groups: one group will use the reSET mobile app for 12 weeks, while the other will receive standard care. The FDA has approved the app for a 12-week treatment program for people with SUD. It helps users reduce their dependence on stimulants by offering therapeutic content on their phones. Additionally, studies suggest that similar apps can help people with HIV adhere to their antiretroviral therapy. While research on mobile apps for SUD treatment continues to expand, reSET has been recognized as a useful tool for managing stimulant use. ^{2 3 6 7 8}

Who Is on the Research Team?

Jose Szapocznik, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for men living with HIV who use stimulants and aren't currently in drug treatment. They must be over 18, patients at certain clinics in Atlanta, Dallas/Fort Worth, Fort Lauderdale, or Los Angeles, not have severe psychiatric symptoms or cognitive impairment, and be less than 90% adherent to their HIV treatment.

Inclusion Criteria

Reports that he is not currently in drug treatment

I am a male or a transgender female without hormonal treatment.

Person living with HIV who is an AIDS Healthcare Foundation (AHF) patient at one of the four metro areas: Atlanta, Dallas/Fort Worth, Fort Lauderdale, Los Angeles

Exclusion Criteria

Persons residing in criminal justice facilities will be excluded because they will not have access to a mobile device as required by reSET

Patients who can benefit from another type of treatment because of severity of stimulant use disorder or opiate use disorder will be referred appropriately

I am mentally capable of understanding and consenting to participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care treatment or use the reSET mobile app for 12 weeks

12 weeks

Follow-up

Participants are monitored for changes in RNA viral load and days of stimulant use

15 months

What Are the Treatments Tested in This Trial?

Interventions

• reSET

Trial Overview The study tests if reSET—a mobile app approved by the FDA—helps men who have sex with men manage stimulant use disorder while maintaining stable HIV viral load suppression. Participants will either receive standard care or use the reSET app alongside their usual treatment.

How Is the Trial Designed?

Group I: reSET Group Experimental Treatment 1 Intervention

Participants in this group will use the reSET mobile app for 12 weeks.

Group II: Standard of Care Group Experimental Treatment 1 Intervention

Participants in this group will receive standard of care treatment for 12 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Drug abuse, particularly with substances like opiates, methamphetamine, and cocaine, can increase HIV replication and contribute to neurotoxicity and damage to the blood-brain barrier, as shown in both in vitro and rodent studies.

Research on the combined effects of drug addiction and HIV on the brain is complicated by the challenges of studying polydrug use and withdrawal in animal models, highlighting the need for further investigation in simian models of HIV-associated neurocognitive disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human immunodeficiency virus-associated neurocognitive disorder: pathophysiology in relation to drug addiction. Nath, A.[2019]

In a study of 194 people living with HIV, there were no significant differences in mood, anxiety, or impulsivity between those treated with dolutegravir and those who had never used it, suggesting that dolutegravir does not contribute to these neuropsychiatric side effects.

Common issues like depression, anxiety, and impulsivity were found in the population, and these were associated with regular substance use rather than the use of dolutegravir, indicating that mental health challenges in this group may stem from factors other than the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance use, Unlike Dolutegravir, is Associated with Mood Symptoms in People Living with HIV. Van de Wijer, L., van der Heijden, W., van Verseveld, M., et al.[2022]

A systematic review of nine randomized controlled trials involving 640 patients found that central nervous system (CNS) stimulants did not significantly improve retention in treatment or reduce cocaine use compared to placebo.

However, dexamphetamine showed a promising reduction in cocaine use, with a lower rate of cocaine-positive urine screens compared to placebo, suggesting potential for further research into specific CNS stimulants like dexamphetamine and modafinil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of central nervous system stimulant treatment for cocaine dependence: a systematic review and meta-analysis of randomized controlled clinical trials. Castells, X., Casas, M., Vidal, X., et al.[2018]

A study involving focus groups of stimulant-using HIV-positive men revealed that app features such as user control, perceived usefulness, and security significantly influence their decision to download and continue using mobile health apps.

Participants suggested that effective ART adherence apps should include social networking features, local resource connections, and engaging feedback mechanisms, highlighting the importance of tailoring app design to meet the specific needs of this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating Effective Mobile Phone Apps to Optimize Antiretroviral Therapy Adherence: Perspectives From Stimulant-Using HIV-Positive Men Who Have Sex With Men. Horvath, KJ., Alemu, D., Danh, T., et al.[2023]

A pilot trial combining contingency management (CM) and behavioral activation (BA) for HIV-infected individuals with stimulant use disorder showed promising results, with participants reporting a significant reduction in self-reported stimulant use by an average of 4.14 days at 3 months and 5.0 days at 6 months.

The intervention was well-received, with 100% retention and attendance, suggesting that this combined approach may enhance the effectiveness and sustainability of treatment for stimulant use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying behavioral activation to sustain and enhance the effects of contingency management for reducing stimulant use among individuals with HIV infection. Mimiaga, MJ., Closson, EF., Pantalone, DW., et al.[2020]

People living with HIV (PLWH) are at a higher risk for substance use disorders (SUDs), particularly with drugs like cocaine and methamphetamine, which can worsen their neurocognitive health and overall well-being.

Chronic use of psychostimulants disrupts brain function and cognition in PLWH, leading to poorer health outcomes, highlighting the need for targeted interventions that address both HIV and substance use issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological, Behavioral, and Pathophysiological Characterization of the Co-Occurrence of Substance Use and HIV: A Narrative Review. Vines, L., Sotelo, D., Giddens, N., et al.[2023]

In a study of 313 participants, those with both HIV and a history of methamphetamine use disorder reported significantly poorer sleep quality compared to those with HIV but no history of methamphetamine use, indicating a strong link between MA use and sleep issues in this population.

Poor sleep quality in HIV+ individuals with a history of methamphetamine use was associated with various negative outcomes, including cognitive impairment and decreased quality of life, suggesting that addressing methamphetamine use could improve overall functioning and well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifetime Methamphetamine Use Disorder and Reported Sleep Quality in Adults Living with HIV. Sun-Suslow, N., Saloner, R., Serrano, V., et al.[2021]

In a study involving 13 HIV+ gay men, the combination of modafinil and cognitive behavioral therapy (CBT) over 16 weeks showed promising results, with 77% of participants completing the trial and 60% reducing their methamphetamine use by more than 50%.

Despite two participants discontinuing modafinil due to side effects, the overall retention and efficacy suggest that this combined treatment approach warrants further investigation in larger, double-blind trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provigil (modafinil) plus cognitive behavioral therapy for methamphetamine use in HIV+ gay men: a pilot study. McElhiney, MC., Rabkin, JG., Rabkin, R., et al.[2021]

In a study of 766 HIV-positive men who have sex with men (MSM), 35% reported stimulant drug use, which was linked to a lower likelihood of completing the study protocol compared to non-drug users.

Participants using other drugs had a significantly lower chance of having a high HIV viral load (≥1500 copies/mL) compared to those who reported no drug use, indicating that drug use behaviors can impact both study participation and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulant Use and Study Protocol Completion: Assessing the Ability of Men Who Have Sex with Men to Collect Dried Blood Spots for Laboratory Measurement of HIV Viral Load. Teran, RA., Carrico, AW., Horvath, KJ., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10373299/

Demonstration of an app-delivered digital therapeutic ... This study assessed the feasibility and utility of a digital, all-virtual program designed for treatment of methamphetamine use disorder (MUD).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6803067/

A Pilot Study of a Mobile App to Support HIV Antiretroviral ... APP+ is a theoretically-grounded mobile app intervention to improve antiretroviral (ART) adherence among men who have sex with men (MSM) who use stimulants.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN160018.pdf

De Novo Summary (DEN160018) Page 1 of 17 RESET FDA ... reSET is indicated as a 12 week (90 days) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid ...

4. iasusa.org iasusa.org/wp-content/uploads/2024/12/32-5-571.pdf

Managing Stimulant Use Among People With HIV This article highlights the cultural significance of stimulant use, its epidemiology, and the latest evidence- based interventions for stimulant ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S294976122400021X

Review Therapeutic Content of Mobile Phone Applications ... This meta-analytical umbrella review of reviews shows there are insufficient data to assert that MPAs, in total, significantly improve SUD-related outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5553728/

Using smartphones to decrease substance use via self ... Secondary outcomes are number of HIV risk behaviors and whether abstinence mediates the effects of EMA, EMI, or EMA + EMI on HIV risk behaviors.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8994143/

Patient- and Provider-Reported Experiences of a Mobile ... This pilot study aims to assess the feasibility and acceptability of reSET-O in a community-based opioid treatment program with a Hub and Spoke model of care.

8. hcplive.com hcplive.com/view/fda-permits-marketing-of-reset-mobile-app-for-sud

FDA Permits Marketing of reSET Mobile App for SUD ... The application could be accessed at home or with the clinician. Results showed that adherence to abstinence was 40.3% for the patient group using the treatment ...