Long-acting naltrexone for pre-release prisoners: A randomized trial of mobile treatment

This five-year NIH/NIDA funded study will focus on whether the addition of providing long-acting naltrexone (XR-NTX) treatment at a patients’ place of residence will increase adherence and thus efficacy of the medication. Project implementation will occur at seven prisons under the jurisdiction of the Maryland Department of Public Safety and Correctional Services (MDPSCS). 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 might 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.

The Effects of Manualized Treatment in a Seamless System

The overarching purpose of this study is to assist offenders in adopting a crime-free, drug-free lifestyle, and to increase the probability that they will successfully complete supervision. The intervention involves three complementary components: 1) an initial collaborative goal-setting session between the drug-involved offender, the Probation Agent (PO), and the Addiction Treatment Counselor or Clinician; 2) 18 weeks of group counseling, involving the drug-involved offenders, the Clinician, and the PO; and 3) 6 sessions designed to help the offender improve communications with significant others and strengthen informal social control networks in the community that can support the offender’s efforts at desistance.

Substance Abuse, HIV/AIDS, and Hepatitis Prevention in urban Native Americans

Now, and for many decades, drug and alcohol use and abuse problems have continued to occur in Native American communities. More recently, HIV/AIDS and hepatitis have appeared in all but a few of these communities. Along with the frustration, pain, and senseless deaths that result from these problems, Native Americans must struggle with treating and preventing a problem that doesn’t seem to fit within their own traditional healing systems. This study seeks to build a foundation for delivering and sustaining effective and culturally relevant services to prevent and reduce the onset of substance abuse (SA), and transmission of HIV/AIDS and hepatitis among urban Native Americans and Native American reentry populations in Baltimore, MD. The overall purpose of this project is to implement a culturally responsive SA/HIV/AIDS/Hepatitis program that will increase and sustain service capacity to Native Americans in order to address SA, HIV, and hepatitis problems. The increases in service capacity are designed to: (1) build skills and knowledge; (2) promote new peer group norms of preventive communications and behaviors; and (3) help sustain new health promoting habits. Using the Strategic Prevention Framework as a model to develop culturally relevant service capacity specifically for urban Native Americans, the five goals of the project are to: (1) Conduct a community needs assessment; (2) Mobilize and build capacity to address SA/HIV and hepatitis prevention needs; (3) Develop a comprehensive strategic plan; (4) Implement evidence based prevention programs and infrastructure development activities; and, (5) Assess program effectiveness. Service capacity will be enhanced through partnership with an urban Native American program, LifeLines Foundation that serves substance abusing Native Americans in Maryland. Through this partnership, we will develop workgroups that provide syntheses of state and local indicator data specifically on Native Americans; select culturally appropriate evidence based programs; and, utilize culturally appropriate evaluations. Culturally competent Native American evaluations will work in partnership with the local community utilizing both quantitative and qualitative methodology that will serve the purposes of on-going monitoring and evaluation in order to assess program effectiveness, ensure service delivery quality, identify successes, encourage needed improvement, and promote sustainability of effective policies, programs, and practices.

SBIRT in New Mexico

Rigorous research is needed to test the effectiveness of screening and brief interventions that can easily be scaled-up to reduce illegal drug use and HIV risk behaviors. The few existing clinical trials of SBIRT for illicit drug use have not examined SBIRT’s impact on HIV risk behavior. The presently proposed study will address this gap in scientific knowledge through a partnership between Friends Research Institute and the Sangre de Cristo Community Health Partnership, the organization responsible for implementing the SAMHSA-funded Screening, Brief Intervention, Referral, and Treatment (SBIRT) Initiative throughout New Mexico since 2003. The study will use a randomized controlled trial to compare the effectiveness of a standardized interpersonal brief intervention (IBI) based on motivational interviewing (currently used in the New Mexico SBIRT initiative) with a promising computerized brief intervention (CBI) in reducing illegal drug use and HIV risk behaviors and their associated health consequences. In addition, the study will assess whether participants’ computer experience differentially moderates the effectiveness of the two interventions. The study will take place at two large primary care clinics in New Mexico. All patients will complete a screening for substance use via the Alcohol, Tobacco, and Substance Involvement Screening Tool (ASSIST) as part of regular clinical care. Patients who score in a moderate-risk category for illegal drug use (n = 360, 180 at each site) will be randomly assigned within their respective clinics to the IBI or CBI condition. Patients with high-risk drug use will be referred for more intensive services as per standard clinical practice. Primary outcomes include drug use levels for major substances of abuse as measured by analysis of hair samples, global illicit drug risk ASSIST scores, and HIV risk behaviors. Secondary outcomes include self-reported frequency of hospitalizations, emergency room utilization, injuries, psychological distress, arrests, missed work days, and earned income. Data analysis will be conducted using a Generalized Linear Mixed Model approach. An effective computerized brief intervention has the potential to make a substantial impact on public health by reducing drug use and HIV risk behaviors because it can be easily scaled up and implemented throughout the health care system.

Risk Factors for HIV Among Urban African American Youth

The primary aim of this cross-sectional study is to examine the extent to which specific risk and protective factors predict both perceptions of HIV risk and participation in risky sexual behavior among high-risk African American youth. These youth, currently attending Alternative Education Programs (AEP), have exhibited academic, school conduct, and behavioral problems. Participants will be 200 male and female students, between the ages of 12 and 16. Half of the participants will be assessed the first project year and the remainder assessed in the second year. This research study has the potential to provide a greater understanding of issues related to perceptions of HIV risk and participation in risky sexual behaviors among high-risk urban African American youth. Findings from the study will be of significance to the field of public health by filling important knowledge gaps in terms of risk for HIV infection among such youth.

Reengineering Methadone Treatment: A Clinical Trial

Premature discontinuation from methadone treatment programs (MTP) is a frequent occurrence and is associated with continued illicit drug use, HIV infection, overdose death, and crime. This NIDA-funded study builds on the findings of our parent grant (5R01DA 015842) in which nearly half of over 350 newly admitted MTP were no longer in treatment at 12-month follow-up, in large part because of the powerful influence of program rules and the role of the counselor as enforcer of the rules. Our goal is to test the impact of a fundamental re-engineering of MTPs, based on the conceptual model of patient-centered care in order to avoid premature drop-out and to improve patient outcomes.

The Patient-Centered Methadone Program (PC-MTP) will reorganize the staff roles and MTP rules such that counselors will not be responsible for enforcing the clinics’ rules for their patients, patients will be encouraged but not required to participate in counseling, and most clinic rule infractions will result in consequences short of “administrative” discharge. This two-site randomized clinical trial with 300 participants will compare, on an intent-to-treat basis, the relative effectiveness of PC-MTP to treatment-as-usual MTP over the course of 12 months of treatment.

Prevention of Relapse to Opioid Addiction using Long-acting Injectable Naltrexone

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. This collaborative project will take place in five treatment sites where there is a large population of parolees with a history of opiate addiction: 1) University of Pennsylvania, Philadelphia, PA: 2) Rhode Island Hospital, Providence, RI; 3) New York University/Bellevue, New York, NY; 4) Columbia University, New York, NY; and 5) Friends Research Institute, Baltimore, MD.

After determining that all volunteers are opiate free by urine test results 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 assessments 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 cash 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.