Michael S. Gordon - US grants

DESCRIPTION (provided by applicant): The proposed research will examine the role of temporal processing in audiovisual speech integration for older and younger adults. Sensory and cognitive changes with age may degrade temporal processing in older adults. If time varying aspects of speech are salient to multimodal integration, then older adults should be impaired relative to younger adults for the coordination of intersensory information. Experiments will test the importance of perceptual speed and the temporal congruity of the modalities for detection of audiovisual speech. This research has implications for multimodal perception, temporal processing of speech, sensory and cognitive changes with age and communication across lifespan.

DESCRIPTION (provided by applicant): Substantial evidence indicates that criminal justice populations are at disproportionately high risk for HIV infection from both injection drug use and unprotected sex. HIV testing and prevention have largely been ignored among community correction (i.e., probation and parole) populations. Despite the demonstrated link between criminal justice involvement and HIV risk behaviors and infection, little is known about the prevalence of HIV risk behaviors and infection among individuals on parole or probation. We propose to conduct both a randomized trial of HIV testing in community corrections, and a single arm intervention (cohort) study of linkage to HIV care for people with HIV recruited through community corrections (probation and parole). The first study is a two-group randomized controlled trial in which 6,000 male and female probationers and parolees in Baltimore City, Maryland and Providence, Rhode Island will be randomly assigned either to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or 2) Off-site referral for rapid HIV testing at a community health center or HIV testing clinic. For the cohort study, all individuals identified at community corrections with HIV will be offered enrollment in a one year intervention study using Project Bridge to help improve linkage into HIV care. The rationale for choosing the two cities of Baltimore, MD and Providence, RI is due to the historically high rates of heroin addiction which is associated with multiple HIV-related risk behaviors and a high likelihood of being on probation and/or parole. Outcomes for the randomized trial will include: a) undergoing HIV testing; and b) receipt of HIV testing results. Outcomes for the cohort study will include: a) time to next (or first) appointment with their HIV provider; b) retention in HIV care, c) initiation of HAART medications for those positive for whom such medications are prescribed; and d) proportion of individuals achieving undetectable HIV plasma viral load over 12 months for those prescribed HAART. PUBLIC HEALTH RELEVANCE: The present proposal is of great significance because of the over 5 million individuals on parole and probation in the US and their disproportionate involvement in drug use and other HIV risk behavior compared to the general population. Furthermore, there are many potential barriers to receiving care in the community that exist for such a marginalized and stigmatized population. The study is highly innovative as we are not aware of reports of attempts to integrate HIV testing and linkage to care in this large at-risk population. Finally, this application is of high public health relevance because of the need to greatly improve access to testing and treatment for at-risk populations to stem the tide of HIV infection in the United States.

DESCRIPTION (provided by applicant): Opioid addiction has remained widespread throughout the United States since the 1960s and a large proportion of users are involved in crimes to support their habits. After release from incarceration, relapse to opioid addiction is very common and this leads to more crimes and re-incarceration. Treatment advances in the area of medications have not reached this population. Effective medications such as methadone and buprenorphine are not well accepted by prosecutors and judges. Permission to conduct research on the most effective treatment approaches is very difficult to obtain for patients under legal restraint because informed consent is problematic. Naltrexone, an opiate receptor antagonist, has demonstrated pharmacological efficacy in preventing relapse to opioid addiction and it has been reported to be clinically effective in parolee populations although it is rarely used. Recently a depot formulation with a one month duration has received FDA approval for the treatment of alcoholism. The purpose of this study is to determine whether a monthly injection of naltrexone is practical and useful in the prevention of relapse and when compared to treatment as usual. We will also monitor HIV risk behaviors to determine whether the intervention reduces risk of HIV and hepatitis C infections. This collaborative project will take place in six treatment sites where there is a large population of parolees with a history of opiate addiction. In order to prevent even a subtle form of coercion, referrals from parole officers will not be accepted. After determining that all volunteers are opiate free by urine test and not currently opiate dependent using a naloxone test, they will be randomized to depot naltrexone or Treatment as Usual (TAU). Participants in both groups will be given identical follow up monthly for six months with measures of opiate use by self-report, urine test and hair analysis. An additional random urine test will take place each month between monthly visits. Both groups will be re-evaluated six and 12 months later. The University of Pennsylvania will be the coordinating site and each site will have a randomization goal of 20 new patients per year over 3.5 to 4 years to accrue a total of 360 to 400 participants. Treatment outcome will be measured by urine tests, hair analysis, self-report and continuation in treatment. Both naltrexone and comparison groups will receive equivalent voucher incentives to remain in the program. A benefit-cost analysis will be conducted to compare the costs of the treatment with the quantifiable benefits in terms of reduced crime, re-incarceration and medical services and increased employment. PUBLIC HEALTH RELEVANCE: This project will test the benefits of a new treatment using a depot medication for preventing relapse to opioid addiction. If successful, it will influence the care given to probationers and parolees and likely relieve some of the overcrowding of our prisons. The data from this study can also be used by the FDA to evaluate the benefits of this treatment that could improve the lives of patients suffering from opioid addiction.

? DESCRIPTION (provided by applicant): Disorders involving opioid use are a severe problem among jail and prison inmates. Inmates in the US, Canada, Australia, and many European and Asian nations have disproportionately higher rates of opioid use disorders than their general populations. Scarce resources are provided for corrections-based substance use treatment in many nations, and many inmates with OUDs remain untreated. The use of long-acting, injectable naltrexone (XR-NTX) may be a promising form of treatment for pre-release prisoners. Naltrexone blocks the intoxicating and reinforcing effects of opioids, but has no opioid-like effects. This proposed five-year study will focus on whether the addition of providing XR-NTX treatment at a patients' place of residence will increase adherence and thus efficacy of the medication. Project implementation will occur at five pre-release prisons under the jurisdiction of the Maryland Department of Public Safety and Correctional Services (MDPSCS): 1) Metropolitan Transition Center (MTC) for men; 2) Baltimore Pre-Release Unit (BPRU) for men; 3) Jessup Pre- Release Unit (JPRU) for men; 4) Baltimore City Correctional Center (BCCC) and 5) Maryland Correctional Institution (MCI) for Women. Following initial screening, informed consent, and medical examination, pre- release prisoners at each facility will be block randomized (N=240) within gender to either: Condition 1. XR- NTX-OTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at an opioid treatment program; or Condition 2. XR-NTX+MMTx (n=120): One injection of XR-NTX in prison, followed by six monthly injections post-release in the community at the patient's place of residence. All participants will be confirmed opiate-free by urine test and negative naloxone and oral naltrexone tests, and evaluated monthly for seven months and 12 months after release from prison. The proposed study has two specific aims: Aim1. To compare the two study conditions in terms of: a) XR-NTX treatment adherence; b) opioid use; c) criminal activity; d) re-arrest; e) re-incarceration; and f) HIV risk-behaviors (i. needle use; ii. risky sexual behaviors). Aim 2. To determine if the number of months of post-release XR-NTX treatment is related to outcome (a-f above), and if so, is there a point at which XR-NTX v. Non-XR-NTX equilibrates? This would help determine the number of injections, important because of XR-NTX cost. Many individuals in the criminal justice system drop out of treatment and therefore increasing ways to improve adherence by attempting to: 1) expand capacity; and 2) implement access by providing treatment at their place of residence may positively impact outcomes.

ABSTRACT This proposed five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program. Project implementation will occur at Guilford Avenue, the primary intake unit for Baltimore City Community Supervision (Probation and Parole). The proposed study is a parallel two-group randomized controlled trial in which 160 men and 160 women with OUD on community supervision in Baltimore will be randomly assigned within community supervision status (probation or parole) and gender to one of two treatment conditions: (1) Buprenorphine Bridge Treatment (BBT): Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment; or (2) Treatment as Usual (TAU): Participants will receive a referral to buprenorphine treatment in the community. Both conditions will receive information on overdose prevention. Participants will be assessed at baseline, and 1, 2, 3, 6, and 12 months post-intake using a comprehensive assessment battery. The Primary Aim: To compare the relative effectiveness of BBT to TAU in terms of: (a) illicit opioid urine test results. The Secondary Aim: To examine the extent to which BBT is superior to TAU in terms of: (b) number of days receiving opioid treatment; (c) number of days using illicit opioids; (d) quality of life (i. physical health; ii. mental health); (e) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); (f) criminal activity; (g) re-arrest; and (h) re-incarceration. The proposed study is significant because the large number of probationers/parolees with OUD have limited access to an efficacious treatment, buprenorphine pharmacotherapy. The proposed study is innovative because it would be the first trial in the US assessing the effectiveness of interim buprenorphine initiated at a community supervision office compared to referral to a community treatment program. The public health impact would be widespread, as this model of care could be scaled-up throughout many areas of the US with criminal justice populations with high rates of OUD.

Abstract The proposed study is a Type 1 hybrid effectiveness-implementation trial. Early adopters from the Maryland extended-release naltrexone (XR-NTX) initiative and additional counties who are willing to provide CAM2038, a new extended-release-buprenorphine (XR-B) formulation will participate in a randomized controlled trial conducted in 7 counties (10 jails) throughout the state of Maryland, in which 240 incarcerated men and women will be randomly assigned within gender within jail to one of two groups: Arm 1. XR-B (n=120). XR-B in jail followed by 6 monthly injections post-release at a community treatment program. Arm 2. XR-NTX (n=120). One injection of XR-NTX in jail, followed by 6 monthly injections post-release at a community treatment program. Aim 1. To determine the effectiveness of XR-B compared to XR-NTX in terms of: Primary. (a) pharmacotherapy adherence (number of monthly injections received). Secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) HIV risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). Aim 2. To use a learning collaborative involving all 7 RCT county jurisdictions as well as 3 additional counties that selected not to participate in the randomized trial to understand factors related to: (a) acceptability of providing long-acting agonists and antagonists in jail settings; and (b) feasibility of providing medication continuity of care from jail to community treatment providers. Aim 3. Calculate the cost to the correctional health system of implementing an XR-B or XR-NTX program, and determine the relative value of each strategy, including the costs associated with the subsequent interventions in the community, from a state- policymaker and societal perspective. The proposed study is innovative because it would be the first randomized clinical trial in the US assessing effectiveness of receiving XR-B vs. XR-NTX in county jails. The public health impact of the study will be highly significant and far-reaching because most individuals with OUD do not receive treatment while incarcerated, thereby substantially raising their likelihood of relapse to drug use, overdose death, HIV/AIDS infection, and re-incarceration. Finally, understanding how to expand acceptance of medications for opioid use disorder in jails, particularly long-acting medications, has far-reaching implications for treatment expansion in this population.