Thursday, December 6
10:15 am – 12:15 pm
Symposium I: Harm Reduction as a Goal in AUD Pharmacotherapy – Role For the WHO Risk Drinking Category Change
Raymond Anton, MD Chairperson; Daniel Falk, PhD, Stephanie O’Malley, PhD, and Bernard Silverman, MD
Summary: While the number of people with Alcohol Use Disorder (AUD) is increasing in the US, most people in need of treatment do not receive it. One reason for the reluctance of many AUD individuals in seeking treatment is the potential requirement for complete abstinence in many treatment programs. While complete abstinence has been shown to be one of the best long-term goals of AUD treatment, it is possible that other goals could be entertained either as intermediate goals prior to abstinence, or potentially as stable treatment outcomes. In fact, the FDA has suggested that drinking short of heavy drinking days is acceptable for FDA approval of new medications to treat AUD. This symposium will present data (compiled by the Alcohol Clinical Trials Initiative (ACTIVE), a private-public partnership examining “best-practices” in AUD clinical trials) that shows that reduction in drinking can lead to reduction in AUD symptoms and consequences. The focus will be on the World Health Organization (WHO) risk drinking level category change (already used in Europe for regulatory approval of new AUD medications) as a potential indicator of harm reduction and how it could be used as an acceptable outcome in future regulatory evaluations for AUD pharmacotherapy. The mission of ACTIVE, the support for harm reduction goals from a national survey (NESARC) conducted in two waves over 3 years (Anton), and from a large NIAAA sponsored Clinical Trial (Falk) will be presented. Data from 3 large multi-site trials will document how a reduction in WHO risk drinking category could be used to observe the efficacy of pharmacotherapy in both clinical trials and practice (O’Malley). The discussant (Silverman) will bring this information together and providce insight into how it could help the medication development process and potentially be useful to broaden treatment options and clinical care.
Friday, December 7
8:00 am – 9:00 am
Founders’ Award: Former Congressman (D-RI); Founder, The Kennedy Forum; Co-Founder, One Mind; Commissioner, President’s Commission on Combating Drug Addiction and the Opioid Crisis
The Honorable Patrick J. Kennedy
9:00 am – 11:00 am
Symposium II: Opioid Use Disorder in Women: Evidence from the National Institute on Drug Abuse Clinical Trials Network (CTN) and the Implications for Treatment
Shelly Greenfield, MD, MPH and Carmen Rosa, MS Co-Chairs; Celestina Barbosa-Leiker, PhD, Aimee Campbell, PhD, Kathryn McHugh, PhD, and Constance Guille, MD, MSCR
Summary: The purpose of this symposium is to provide an overview of the opioid epidemic among women and describe women-specific issues that are significant and relevant to opioid use disorder (OUD) treatment and response. This symposium has great relevance for clinical practice including addressing practice gaps in preventing rising death rates among women by opioid overdose, the need to treat co-occurring psychiatric disorders and pain, and suicide prevention in women with OUD, and treatment of pregnant and postpartum women with OUD and their infants. Speakers will present (1) an epidemiological overview including information on the rise in prescription opioid, heroin, and fentanyl deaths in women, as well as the epidemiology of both race and gender in OUD overdose deaths (20 min); (2) sex differences in baseline demographic and clinical characteristics from CTN 0051 (randomized controlled trial of Naltrexone ER versus Buprenorphine) including data demonstrating that compared with men, women in this trial were younger, had a telescoping course of OUD, had greater sexual risk behaviors and financial vulnerability, among other important clinical and sociodemographic characteristics (20 min); (3) co-occurring pain, anxiety disorders, trauma, and PTSD among with women with OUD (including results from the CTN 31- Prescription Opioid Addiction Treatment Study), the implications for treatment, as well as the increase in benzodiazepine prescribing in this population (20 min); (4) OUD in pregnant women, neonatal opioid withdrawal syndrome (NOWS) in newborns, and post-partum care including the evidence for opioid agonist treatment of pregnant women with OUD, and treatment of newborns with (NOWS) (20 min); and (5) Discussion of these data including summary of key points, implications for treatment of women with OUD and the epidemic more generally, and relevant next steps for research and practice (20 min); (6) Question and answer interactive session with attendees (20 min).
4:30 pm – 6:00 pm
Case Conference – Topic: A medically hospitalized woman with opioid use disorder
Michael Scimeca, MD and S. Alex Sidelnik, MD
Summary: The case will focus on a woman with opioid use disorder (OUD) who was seen on an inpatient medical unit. This will highlight a number of important aspects of addiction treatment including gender diversity, successful engagement of individuals with OUDs in medical settings, special considerations of managing OUD during medical hospitalizations, and structural barriers to providing medical treatment for individuals with substance use disorders.
Saturday, December 8
8:45 am – 10:45 am
Symposium III: A New Era of Treating Substance Use Disorders with Psychedelics
Bryan Adinoff, MD Chairperson; Roland Griffiths, PhD, Peter Hendricks, PhD, Albert Garcia-Romeu, PhD, MA, and Michael Bogenschutz, MD
Summary: Research investigating psychedelic drugs as treatments for drug addiction began in the 1950s, but was terminated in the 1970s due to concerns of nonmedical use, a misunderstanding of the risks, and the political environment. In recent years, however, the interest in the potential of these drugs for the treatment of various psychiatric disorders has dramatically increased. The heightened awareness of the therapeutic potential of psychedelics has yielded several exciting new clinical studies, suggesting a novel approach for the treatment of substance use disorders. This symposium will review recent and ongoing research by leaders in this emerging field. In their studies using the classic psychedelic psilocybin, the presenters will describe their paradigms, safety procedures, outcomes and potential mediators of effectiveness. Roland Griffiths will begin the session by reviewing past and recent data showing that both healthy volunteers and psychologically distressed cancer patients report positive changes in moods, attitudes and behavior lasting at least 6 months after psilocybin treatment. Peter Hendricks will present preliminary observations from an ongoing double-blind placebo-controlled trial of psilocybin in the treatment of cocaine use disorder. Albert Garcia-Romeu will review outcomes from a previous pilot study of psilocybin treatment of cigarette smoking (tobacco use disorder) and preliminary findings from an ongoing study comparing psilocybin with nicotine-replacement treatment of cigarette smoking. Michael Bogenschutz will review data from a previous pilot study of psilocybin treatment of alcohol use disorder and an ongoing double-blind study comparing psilocybin with diphenhydramine treatment. Bryon Adinoff will discuss the promising results of these trials, possible neurobiological mechanisms, and the implications for future research with psilocybin and other psychedelics for the treatment of substance use disorders.
3:15 pm – 5:15 pm
Symposium IV: Fentanyl and the current opioid epidemic
Thomas Kosten, MD Chairperson; Frances Levin, MD, Jane Maxwell, PhD, Sandra Comer, PhD, and John Mariani, MD
Summary: The goal of this symposium is to provide clinicians with a broad overview of fentanyl’s impact on opioid overdoses, its potential to override FDA-approved treatment agents such as buprenorphine and naltrexone, and alternative agents to prevent abuse and overdoses with fentanyl. First, epidemiological data will show the geographic variations in the prevalence of fentanyl, opioids and stimulants based on mortality and toxicological data across the U.S. Current data show important use patterns based on the type of heroin and/or other drugs such as methamphetamine, cocaine, or other opioids. Second, we will present a clinical perspective on buprenorphine treatment complicated by fentanyl abuse and street overdoses have increased. Clinicians in NYC are finding that 80% of the heroin users in these clinics have positive fentanyl urines. Whether fentanyl overdoses require repeated naloxone doses needs direct empirical examination, but certainly, emergency medical technicians in the field are indicating that they have to give multiple doses to reverse these overdoses. This can be a major problem for naloxone use in “civilian” overdose reversals, since 2 mg intranasal doses of naloxone appear ineffective. The third presentation will review the likely efficacy of clinically used doses of naltrexone and buprenorphine for blocking fentanyl abuse or overdose. This blocking may be particularly important for the depot formulations of naltrexone and buprenorphine, because these formulations have lower blood (and presumably brain) levels than 50 mg daily naltrexone or than 24 mg/day buprenorphine. Human laboratory studies can directly examine the dose related efficacy of buprenorphine for fentanyl blockade. Fourth, we will present new data on a fentanyl vaccine that specifically blocks fentanyl, but not other opiates, as a prevention measure for fentanyl overdose and abuse. Most of these data will be original and not previously presented. The clinical implications of fentanyl abuse for over-riding the blockade from naltrexone or buprenorphine as well as for causing overdoses are important to convey to patients and to develop new pharmacologic treatments such as a fentanyl vaccine.