Mobile Therapy for Stimulant Use Disorder in HIV
(COSTA Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Must be taking: Antiretrovirals
Disqualifiers: Cognitive impairment, Severe psychiatric symptoms, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.
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 data supports the effectiveness of the treatment reSET for stimulant use disorder in HIV?
The research suggests that combining contingency management (reward-based therapy) with behavioral activation (engaging in positive activities) can help reduce stimulant use in people with HIV. This approach was well-received and showed a reduction in stimulant use over six months, indicating it might enhance the effectiveness of treatments like reSET.
12345Is the mobile therapy for stimulant use disorder in HIV safe for humans?
The research on the combined contingency management and behavioral activation intervention for stimulant use disorder in HIV-positive individuals suggests it was well-received and acceptable, with participants attending all sessions and rating it positively. This indicates that the intervention was generally safe for the participants involved in the study.
12367How is the treatment reSET unique for stimulant use disorder in HIV?
The treatment reSET is unique because it combines mobile therapy with contingency management (reward-based incentives) and behavioral activation (engaging in positive activities) to help reduce stimulant use in individuals with HIV, offering a novel approach compared to traditional methods that may not sustain long-term effects.
13489Eligibility Criteria
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.
I am a man who has had sex with men in the past year.
+8 more
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: reSET GroupExperimental Treatment1 Intervention
Participants in this group will use the reSET mobile app for 12 weeks.
Group II: Standard of Care GroupExperimental Treatment1 Intervention
Participants in this group will receive standard of care treatment for 12 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Applying behavioral activation to sustain and enhance the effects of contingency management for reducing stimulant use among individuals with HIV infection. [2020]There is a high prevalence of stimulant use among HIV-infected individuals, which is associated with suboptimal antiretroviral therapy (ART) adherence, HIV treatment interruptions, detectable HIV viral load, and transmission of HIV via increased sexual risk behavior. Contingency management (CM) is an initially effective treatment for stimulant use. However, the effects of CM are not sustained after the active intervention has ended. One potential contributor to the intractability of existing treatments may be a lack of attention to replacement activities or the role of depressed mood. Behavioral activation (BA) is an evidence-based approach for depression that involves identifying and participating in pleasurable, goal-directed activities. As a potential approach to address the CM rebound effect - informed by our formative qualitative research with the participant population - we conducted an open pilot trial of an intervention combining CM-BA for HIV-infected individuals with stimulant use disorder. Participants completed weekly BA therapy sessions (10-16 sessions) and thrice-weekly toxicology screenings (12 weeks); contingencies were rewarded for negative toxicology tests to support reengagement into positive life activities. Major assessments were conducted at baseline, 3-, and 6-months. Toxicology screening was repeated prior to the 6-month assessment. Eleven participants with stimulant use disorder enrolled; 7 initiated treatment and completed the full intervention. The mean age was 46 (SD = 5.03) and 14% identified as a racial/ethnic minority. Of the completers, the mean change score in self-reported stimulant use within the past 30 days (within-person change; reduction in self-reported stimulant use) was 4.14 days at 3 months and 5.0 days at 6 months [Cohen's d = 0.89]. The mean change score in weekly toxicology screens (reduction in positive toxicology screens) was .71 at 3 months and 1 at 6 months [Cohen's d = 1.05]. Exit interviews indicated that the integrated intervention was well received and acceptable. This study provides preliminary evidence that a combined CM-BA intervention for this population was feasible (100% retention at 6-months), acceptable (100% of intervention sessions attended; participants rated the intervention 'acceptable' or 'very acceptable'), and may be an option to augment the potency and sustained impact of CM for this population. Future pilot testing using a randomized controlled design is warranted.
Creating Effective Mobile Phone Apps to Optimize Antiretroviral Therapy Adherence: Perspectives From Stimulant-Using HIV-Positive Men Who Have Sex With Men. [2023]The use of stimulant drugs among men who have sex with men (MSM) with human immunodeficiency virus (HIV) is associated with decreased odds of antiretroviral therapy (ART) adherence and elevated risk of forward HIV transmission. Advancing tailored and innovative mobile phone-based ART adherence app interventions for stimulant-using HIV-positive MSM requires greater understanding of their needs and preferences in this emerging area.
Neurological, Behavioral, and Pathophysiological Characterization of the Co-Occurrence of Substance Use and HIV: A Narrative Review. [2023]Combined antiretroviral therapy (cART) has greatly reduced the severity of HIV-associated neurocognitive disorders in people living with HIV (PLWH); however, PLWH are more likely than the general population to use drugs and suffer from substance use disorders (SUDs) and to exhibit risky behaviors that promote HIV transmission and other infections. Dopamine-boosting psychostimulants such as cocaine and methamphetamine are some of the most widely used substances among PLWH. Chronic use of these substances disrupts brain function, structure, and cognition. PLWH with SUD have poor health outcomes driven by complex interactions between biological, neurocognitive, and social factors. Here we review the effects of comorbid HIV and psychostimulant use disorders by discussing the distinct and common effects of HIV and chronic cocaine and methamphetamine use on behavioral and neurological impairments using evidence from rodent models of HIV-associated neurocognitive impairments (Tat or gp120 protein expression) and clinical studies. We also provide a biopsychosocial perspective by discussing behavioral impairment in differentially impacted social groups and proposing interventions at both patient and population levels.
Provigil (modafinil) plus cognitive behavioral therapy for methamphetamine use in HIV+ gay men: a pilot study. [2021]To evaluate the efficacy of modafinil combined with cognitive behavioral therapy (CBT) for treatment of methamphetamine (MA) dependence among HIV+ gay men.
Substance use, Unlike Dolutegravir, is Associated with Mood Symptoms in People Living with HIV. [2022]Contradictory data have been reported concerning neuropsychiatric side effects of the first-line antiretroviral drug dolutegravir, which may be partly due to lack of control groups or psychiatric assessment tools. Using validated self-report questionnaires, we compared mood and anxiety (DASS-42), impulsivity (BIS-11), and substance use (MATE-Q) between dolutegravir-treated and dolutegravir-naive people living with HIV (PLHIV). We analyzed 194, mostly male, PLHIV on long-term treatment of whom 82/194 (42.3%) used dolutegravir for a median (IQR) of 280 (258) days. Overall, 51/194 (26.3%) participants reported DASS-42 scores above the normal cut-off, 27/194 (13.5%) were classified as highly impulsive, and 58/194 (29.9%) regularly used recreational drugs. Regular substance use was positively associated with depression (p = 0.012) and stress scores (p = 0.045). We observed no differences between dolutegravir-treated and dolutegravir-naive PLHIV. Our data show that depressed and anxious moods and impulsivity are common in PLHIV and associate with substance use and not with dolutegravir use.
Lifetime Methamphetamine Use Disorder and Reported Sleep Quality in Adults Living with HIV. [2021]This study evaluated whether a history of lifetime methamphetamine (MA) use disorder increases risk for poor sleep quality in people with or without HIV infection (HIV+/HIV-). Participants (n = 313) were stratified into four groups based on HIV status and lifetime MA use disorder diagnosis [HIV+/MA+ (n = 84); HIV+/MA- (n = 141); HIV-/MA+ (n = 16); and HIV-/MA- (n = 72)] and compared on global sleep outcomes using the Pittsburgh Sleep Quality Index (PSQI). Significant differences on global sleep were observed between HIV+/MA+ and HIV+/MA- groups, but not between the HIV- groups. Follow-up multiple regression analyses within the HIV+ subgroups examined global sleep scores as a function of MA status and clinical covariates, including those related to HIV disease and demographics. HIV+ individuals with a history of MA use disorder evidenced significantly poorer sleep quality and were more likely to be classified as problematic sleepers than those without a lifetime disorder. This was independent of depressed mood, body mass index, and viral suppression while on treatment. Poorer reported sleep quality among HIV+/MA+ was associated also with multiple adverse functional outcomes, including greater objective cognitive impairment, unemployment, clinical ratings of functional impairment, and self-reported cognitive difficulties, decreased independence in activities of daily living, and poorer overall life quality. Interventions to avoid or curtail MA use in HIV+ individuals may help protect sleep quality and improve functioning.
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. [2021]Stimulant use is associated with higher HIV viral load (VL) and sexual HIV transmission risk among men who have sex with men (MSM) living with HIV. There is little research on willingness of drug users living with HIV to fully participate in studies, especially those involving self-collection of biomarker data. This study presents findings from an at-home dried blood spot collection study measuring laboratory-quantified VL among U.S. HIV-positive MSM who reported high-risk sexual behavior and/or suboptimal antiretroviral therapy (ART) adherence to assess the association between drug-use behavior and (1) ability to complete a study protocol and (2) VL outcomes. Among recruited participants (n = 766), 35% reported stimulant drug use (amphetamines, cocaine, crack, crystal meth, ecstasy, or a combination of stimulant drugs), 39% reported using other drugs (heroin, marijuana, prescription opioids, and others), and 27% reported no drug use in the past 3 months. In all, 61% of enrolled participants completed the study protocol. Stimulant drug users were less likely (ARR 0.84; 95% CI 0.72-0.98) to complete the protocol than other drug users. Furthermore, other drug users were significantly less likely than non-drug users (ARR 0.52; 95% CI 0.28-0.97) to have an HIV VL result ≥ 1500 copies/mL. This study provides important estimates regarding the likelihood of participation in biomedical research activities among HIV-positive MSM with varying drug-use behaviors, showing that it is feasible to conduct such biomedical studies with drug-using MSM who report high-risk sexual behavior and struggle with their ART adherence.
Efficacy of central nervous system stimulant treatment for cocaine dependence: a systematic review and meta-analysis of randomized controlled clinical trials. [2018]To evaluate the efficacy of central nervous system (CNS) stimulants compared with placebo for the treatment of cocaine dependence.
Human immunodeficiency virus-associated neurocognitive disorder: pathophysiology in relation to drug addiction. [2019]Human immunodeficiency virus (HIV) infection in the United States and increasingly in other parts of the world is now being driven by drug-abusing populations. Both HIV infection and drugs of abuse affect the basal ganglia, hippocampal structures, and the prefrontal cortex. Understanding the interactions between the two and their combined effects is critical. In vitro studies show that opiates, methamphetamine, and cocaine can potentiate HIV replication and can enhance or synergize with HIV proteins to cause glial cell activation, neurotoxicity, and breakdown of the blood-brain barrier. Many of these studies have been confirmed in vivo by using rodent models. However, the complexities of polydrug addiction and drug withdrawal have yet to be examined in simian models of HIV-associated neurocognitive disorder. Clinical studies in substance-abusing, HIV-positive patients pose multiple challenges whether aimed at studying disease pathogenesis or conducting clinical trials. This review examines the literature to date, lists the experimental challenges faced by researchers studying effects of drug addiction on HIV neuropathogenesis, and suggests future directions for research.