Revisiting Preaddiction.

The directors of the National Institute on Drug Abuse and the National Institute on Alcohol Abuse and Alcoholism have proposed new efforts to enable earlier identification and intervention for harmful substance use and its consequences. As editors of The ASAM Principles of Addiction Medicine, we fully support this goal. The word "preaddiction" has been suggested as a diagnostic label to describe individuals who would be targeted for early intervention.

Experience Starting an Addiction Medicine Practice-based Research Network.

Objectives: This paper outlines the experience developing Addiction Medicine Practice-Based Research Network (AMNet), which promotes the adoption of patient-reported outcome measures (PROMs) and measurement-based care in outpatient addiction treatment practices and creates a platform for quality improvement and research.

Methods: From August 2019 to July 2023, the AMNet team selected patient-reported outcome measures for implementation in the American Psychiatric Association's clinical data registry (PsychPRO), recruited addiction medicine providers, and collected PROMs data.

Results: AMNet selected 12 PROMs for implementation in PsychPRO.

Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial.

To test esmethadone (REL-1017) as adjunctive treatment in patients with major depressive disorder (MDD) and inadequate response to standard antidepressants. In this phase 3, double-blind, placebo-controlled trial, outpatients with MDD () were randomized to daily oral esmethadone (75 mg on day 1, followed by 25 mg daily on days 2 through 28) or placebo between December 2020 and December 2022. The primary efficacy measure was change from baseline (CFB) to day 28 in the Montgomery-Asberg Depression Rating Scale (MADRS) score.

Patient Engagement in and Adaptations to Delivery of Outpatient Care for Opioid Use Disorder During the COVID-19 Pandemic.

Objective: The authors investigated adaptations to outpatient care delivery and changes in treatment demand and engagement among patients receiving medications for opioid use disorder (MOUD) in the months after the declaration of the COVID-19 public health emergency in 2020.

Methods: Data were collected through an online survey (June-November 2020) of outpatient MOUD prescribers. The survey obtained information on outpatient practices' adaptations to MOUD treatment and urine drug screening (UDS) and elicited provider views on the effects of the COVID-19 pandemic on patient demand for, and engagement in, treatment.

The novel uncompetitive NMDA receptor antagonist esmethadone (REL-1017) has no meaningful abuse potential in recreational drug users.

Esmethadone (REL-1017) is the opioid-inactive dextro-isomer of methadone and a low-affinity, low-potency uncompetitive NMDA receptor antagonist. In a Phase 2, randomized, double-blind, placebo-controlled trial, esmethadone showed rapid, robust, and sustained antidepressant effects. Two studies were conducted to evaluate the abuse potential of esmethadone.

Psychedelic drug abuse potential assessment research for new drug applications and Controlled Substances Act scheduling.

New medicines containing classic hallucinogenic and entactogenic psychedelic substance are under development for various psychiatric and neurological disorders. Many of these, including psilocybin, lysergic acid diethylamide (LSD), and 3,4-methylenedioxymethamphetamine (MDMA) are Schedule I controlled substances of the United States Controlled Substances Act (US CSA), and similarly controlled globally. The implications of the CSA for research and medicines development, the path to approval of medicines, and their subsequent removal from Schedule I in the US are discussed.

Novel rapid-acting sublingual nicotine tablet as a cigarette substitution strategy.

Rationale: Current nicotine replacement products provide a much slower onset of nicotine delivery than cigarettes, and hence are only marginally effective at supplanting cigarette smoking. Therefore, more effective forms of nicotine replacement are needed.

Objectives: This initial investigation characterized the pharmacokinetic (PK) and subjective effects of a novel sublingual (SL) nicotine tablet designed to deliver nicotine more rapidly to the bloodstream of smokers.

Addiction Medicine Practice-Based Research Network (AMNet): Assessment Tools and Quality Measures.

Introduction: The need for innovative approaches to address the opioid epidemic in the United States is widely recognized. Many challenges exist to addressing this epidemic, including the obstacles outpatient substance use treatment practices face in implementing measurement-based care (MBC), quality measurement systems, and evidence-based treatments. Also, there are insufficient opportunities for clinicians in these settings to participate in research, resulting in diminished translation of research findings into community-based practice.

Addiction Medicine Practice-Based Research Network (AMNet): Building Partnerships.

This column describes the collaboration among the American Psychiatric Association (APA), American Society of Addiction Medicine, Friends Research Institute, and the National Institute on Drug Abuse to create the Addiction Medicine Practice-Based Research Network (AMNet). The collaboration, which aims to address the opioid overdose epidemic in the United States, leverages the APA's clinical data registry (PsychPRO) and is recruiting office-based addiction medicine and addiction psychiatry practices for AMNet. AMNet aims to address knowledge gaps regarding patient care in such practices, facilitate performance improvement efforts, and serve as a research platform.

A clinical protocol of a comparative effectiveness trial of extended-release naltrexone versus extended-release buprenorphine with individuals leaving jail.

This study is a randomized, open label, controlled trial of extended-release buprenorphine (XR-B; BRIXADI™ formulation) versus extended-release naltrexone (XR-NTX) in Maryland jails. A 7-site, open-label, equivalence design will randomly assign 240 adults with a history of opioid use disorder (OUD), stratified by gender and jail, who are nearing release to one of two treatment arms: 1) XR-B in jail or 2) XR-NTX in jail, both followed by 6 monthly injections postrelease at a community treatment program. The primary aim is to determine the rate of pharmacotherapy adherence (number of monthly injections received) of XR-B compared to XR-NTX.

Health and economic outcomes of treatment with extended-release naltrexone among pre-release prisoners with opioid use disorder (HOPPER): protocol for an evaluation of two randomized effectiveness trials.

Background: Persons with an opioid use disorder (OUD) who were incarcerated face many challenges to remaining abstinent; concomitantly, opioid-overdose is the leading cause of death among this population, with the initial weeks following release proving especially fatal. Extended-release naltrexone (XR-NTX) is the most widely-accepted, evidence-based OUD pharmacotherapy in criminal justice settings, and ensures approximately 30 days of protection from opioid overdose. The high cost of XR-NTX serves as a barrier to uptake by many prison/jail systems; however, the cost of the medication should not be viewed in isolation.

Longitudinal analysis of HIV-risk behaviors of participants in a randomized trial of prison-initiated buprenorphine.

Background: It has been estimated that approximately 15% of people who are incarcerated in the US have histories of opioid use disorder. Relapse to opioid use after release from prison poses a serious risk of HIV infection. Prison-initiated buprenorphine may help to reduce HIV infection given the association between opioid use and HIV-risk behaviors.

A randomized controlled trial of buprenorphine for probationers and parolees: Bridging the gap into treatment.

Background: Buprenorphine can be effective in a variety of community substance use treatment settings outside of methadone programs, including outpatient programs and medical practices. In these settings, it has been found to be effective in reducing opioid use and retaining patients in treatment. Despite its effectiveness and safety, it is rarely provided to individuals with opioid use disorders in probation and parole settings.

A cholecystokinin B receptor antagonist and cocaine interaction, phase I study.

Aims: RPR 102681, a cholecystokinin-B antagonist, increased dopamine (DA) release and reduced cocaine self-administration in animals. This pilot study sought to assess the safety and pharmacokinetics (PK) of co-administration of RPR 102681 and cocaine, and to confirm the DA release mechanism of RPR 102681.

Methods: Sixteen cocaine-dependent participants were randomized to either placebo or RPR102681 at 3 ascending doses; cocaine was co-administered at steady state of RPR 102681.

Initiating buprenorphine treatment prior to versus after release from prison: Arrest outcomes.

Background: This secondary analysis of a randomized trial examines the association between initiation of buprenorphine treatment prior to, versus post-release, and rearrests during the 12-months following release.

Methods: Official rearrest data (N = 199) for the 12-months post-release were examined. Four outcomes were measured: (1) rearrested (yes/no), (2) time to rearrest, (3) number of rearrests, and (4) severity of charges (less severe vs.

Extended-release naltrexone (XR-NTX) for opioid use disorder in clinical practice: Vivitrol's Cost and Treatment Outcomes Registry.

Background And Aims: Extended-release naltrexone (XR-NTX), a μ-opioid receptor antagonist for prevention of relapse to opioid dependence, has demonstrated efficacy compared with placebo and comparative effectiveness with buprenorphine-naloxone. We report outcomes for XR-NTX in Vivitrol's Cost and Treatment Outcomes Registry.

Design: Observational, open-label, single-arm, multi-center registry assessing baseline characteristics and clinical and health-related quality-of-life outcomes associated with XR-NTX treatment in clinical practice.

Avatar-assisted therapy: a proof-of-concept pilot study of a novel technology-based intervention to treat substance use disorders.

Background: Avatar-assisted therapy (AAT) is a novel and emerging technology that uses the Internet to enable clinicians and clients in substance abuse treatment to participate in group counseling sessions from separate and remote locations in real time through the use of avatars and virtual environments.

Objectives: The current study is a pilot proof-of-concept feasibility study involving individuals in outpatient substance abuse treatment. This report addresses two questions: (1) are individuals who present for substance abuse treatment interested in receiving AAT and (2) what factors are associated with better treatment success.

A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release.

Background: This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting.

Methods: Study design was a 2 (In-Prison Treatment: Condition: Buprenorphine Treatment: vs. Counseling Only)×2 [Post-Release Service Setting Condition: Opioid Treatment: Program (OTP) vs.

Extended-release naltrexone for pre-release prisoners: A randomized trial of medical mobile treatment.

Background: Extended-release naltrexone (XR-NTX), is an effective treatment for opioid use disorder but is rarely initiated in US prisons or with criminal justice populations. Mobile treatment for chronic diseases has been implemented in a variety of settings. Mobile treatment may provide an opportunity to expand outreach to parolees to surmount barriers to traditional clinic treatment.

Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial.

Importance: The effectiveness of buprenorphine treatment of opioid dependence is limited by suboptimal medication adherence, abuse, and diversion.

Objective: To determine whether 6-month buprenorphine implants are noninferior to daily sublingual buprenorphine as maintenance treatment for opioid-dependent patients with stable abstinence.

Design, Setting, And Participants: Outpatient, randomized, active-controlled, 24-week, double-blind, double-dummy study conducted at 21 US sites from June 26, 2014, through May 18, 2015.

Buprenorphine dose induction in non-opioid-tolerant pre-release prisoners.

Background: In a previously reported randomized controlled trial, formerly opioid-dependent prisoners were more likely to enter community drug abuse treatment when they were inducted in prison onto buprenorphine/naloxone (hereafter called buprenorphine) than when they received counseling without buprenorphine in prison (47.5% vs. 33.

A Phase 4, Pilot, Open-Label Study of VIVITROL® (Extended-Release Naltrexone XR-NTX) for Prisoners.

This was a Phase 4, pilot, open-label feasibility study of extended-release injectable naltrexone (XR-NTX) administered to pre-release prisoners having a history of pre-incarceration opioid disorder. We evaluated the relationship between XR-NTX adherence and criminal recidivism (re-arrest and re-incarceration) and opioid and cocaine use. Twenty-seven pre-release male and female prisoners who had opioid disorders during the year prior to index incarceration were recruited and received one XR-NTX injection once each month for 7 months (1 injection pre-release from prison and 6 injections in the community) and of those 27, 10 (37%) were retained in treatment at 7-months post release.

Electronic cigarettes in adults in outpatient substance use treatment: Awareness, perceptions, use, and reasons for use.

Background And Objectives: Most studies on e-cigarettes have come from population-based surveys. The current research aimed to provide initial data on e-cigarette awareness, perceptions, use, and reasons for use among adults seeking substance use treatment.

Methods: A survey was conducted among 198 participants ≥18 years old in a community-based outpatient substance use treatment program.