ACTTION Phenotyping Substance Use Disorder

RELEVANCE: Phenotyping is a tool that has been recently introduced in the study of addiction and can be used to improve diagnosis and overall treatment outcomes. It aids in the identification of biological and behavioral markers of severity that can be useful in determining response to treatment. A recent study examined the feasibility and administration of the NIDA Phenotyping Assessment Battery (PhAB), a modular package of assessments and neurocognitive tasks, but the need for a…

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Expression of stress markers in MSM living with HIV receiving contingency management for methamphetamine use disorder (a.k.a. “EXPRESS+”)

RELEVANCE: Determining whether a patient is both feeling better and improving physiologically when treating people living with HIV (PLWH) for methamphetamine use disorder (MUD) requires identification of a clinically significant measure separate from abstinence. This study aims to address this challenge by testing a gene expression pattern identified by the field of social genomics, which may provide insight into both psychosocial health and biological processes that impact chronic disease risk in PLWH receiving MUD treatment.…

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HVTN 302: A phase 1, randomized, open-label clinical trial to evaluate the safety and immunogenicity of HIV trimer mRNA vaccines in healthy, HIV-uninfected adult participants.

RELEVANCE: Development of effective vaccines to protect individuals against HIV is a challenging and growing public health priority. The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV globally. DESCRIPTION: The HVTN 302 study is a phase 1 clinical trial looking to evaluate the safety and immunogenicity (how the immune system responds)…

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Inflammation in Methamphetamine and STIs (aka IMSTI)

RELEVANCE: Methamphetamine (MA) use is common among MSM and is an important driver of the HIV/STI epidemic. Understanding the biological and behavioral risk factors that drive ongoing HIV/STI transmission among MA-using MSM is critical to designing potent HIV prevention interventions. Prevalence of MA use is substantially higher among MSM (5.9% among HIV-negative MSM and 12.3% among MSM living with HIV) than the general population (0.7%) (2,3), with a 707% increase in MA-related mortality in Los…

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Phase 1B Drug-Drug Interaction Safety Trial of CS-1103 and a Relevant Challenge with IV Methamphetamine

RELEVANCE: There are no FDA approved medications for the treatment of Methamphetamine Use Disorder (MUD). Current treatment options rely heavily on counseling and behavioral interventions. Scientific evidence supports a combination strategy of pharmacotherapy approaches with behavioral therapies to improve patient outcomes and redefine treatment approach for stimulant use disorder. DESCRIPTION: Clear Scientific has developed CS-1103, the first rationally derived small molecule that has capacity for removing methamphetamine from the body. Funded by a grant from…

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Randomized, Double-Blind, Placebo-Controlled Trial of Monthly Injectable Buprenorphine for Methamphetamine Use Disorder (MURB)

RELEVANCE: The fourth wave of the opioid crisis involves increasing polydrug stimulant and opiate use. Incidence of overdose deaths due to polysubstance use involving opioids co-occurring with methamphetamine increased from 2017 to 2018 by 14.6%. According to the National Survey on Drug Use and Health in 2018, an estimated 1,867,000 of persons in US aged 12 years and older, reported methamphetamine use in the past year and 1,051 000 reported substance use disorder in the…

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Randomized, Placebo-Controlled Trial of Injectable Naltrexone and Monthly Injectable Buprenorphine for Cocaine Use Disorder (CURB-2)

RELEVANCE: Cocaine is one of the most commonly abused stimulants globally, and in the US, there are signs of a resurgence of cocaine use. A variety of pharmacotherapies for cocaine use disorder (CUD) has been explored but so far, no study has findings robust enough to warrant FDA approval. Recent research suggests that a kappa opioid receptor antagonist can curb the negative emotional states associated with stimulant withdrawal that leads to increased craving and drug-seeking behaviors.…

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