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

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. This protocol builds up on results of the Cocaine Use Reduction with Buprenorphine (CURB) study. It aims to evaluate the safety and efficacy of combined monthly injections of extended release naltrexone (XR-NTX) and injectable Buprenorphine (BUP) for Cocaine use disorder (CUD) compared to placebo.

NIDA K23-DA045928-02 Patient-Oriented Career Development Award, Mentalizing deficits in cocaine addiction, associations with immune dysregulation and childhood maltreatment. Role: Principal Investigator

Drug addicted individuals frequently experience social stress (e.g., childhood maltreatment) which may impact interpersonal functioning, exacerbate illness risk (e.g., craving, relapse), and shape neural and physiological responses to stress. This study is aimed at characterizing these complex relationships by: (I) characterizing the behavioral and neural correlates of deficits in mentalizing in cocaine addicted individuals vs. matched healthy controls, using two well-validated functional magnetic resonance imaging paradigms that robustly activate the mentalizing network and characterization of Social Navigation; (II) comparing inflammation between the two study groups, using an immune-blood-profile previously associated with cocaine use, but here examined for the first time vis-à-vis mentalizing and childhood maltreatment; and (III) discerning whether inflammation markers mediate the relationships between childhood trauma with altered neural engagement/behavior during a novel mentalizing task. A better understanding of social cognitive impairments in cocaine addicted individuals, and particularly how they may be related to psychophysiological and social-environmental elements, may inform more effective treatment strategies, improving quality of life, and reducing societal burden.

Social Navigation in Cocaine Addiction in collaboration with Daniela Schiller, Ph.D.

We have added to the K23 protocol an fMRI task that depicts a Map for Social Navigation for a comprehensive assessment of other social-cognitive factors that are beyond mentalizing. Social interactions can be framed by domains of power (being submissive or authoritative) and affiliation (sharing private information or intimacy), guided by episodic memory of prior social interactions. Revealing neural substrates of social interactions is complex because it is a dynamic phenomenon that requires consideration of ongoing changes in responses to social encounters. A well-validated and naturalistic fMRI paradigm, the Social Navigation task, has resulted in a two-dimensional geometric model of social interactions as shown by a ‘social space’ framed by power and affiliation in healthy individuals. Hippocampal brain activity predicted changes in subjective affiliation and power between people and fictional characters in a virtual role-playing game.

NIDA UG3/UH3 Clinical Trial 1UG3 DA050323-01 Principal Investigator: Yasmin Hurd, PhD; Co-Investigator: Keren Bachi, PhD, LSCW 

Development of Medications to Prevent and Treat Opioid Use Disorders and Overdose. Cannabidiol in the treatment of opioid use disorder: A randomized, double-blinded, placebo-controlled study of pharmacological and long-term effects of Cannabidiol administration on opioid craving, relapse, and psychosocial functioning in individuals with opioid use disorder.