Social Research Center

Research Projects

A Phase 4, Pilot, Open-label Study of VIVITROL® in the Prevention of Re-arrest and Re-incarceration

This is a Phase 4, open-label, longitudinal study with a pre-post design (N=30). Pre-release opioid-dependent participants from two Maryland prisons (one for men and one for women) will receive one injection of VIVITROL® (naltrexone for extended-release injectable suspension) prior to release from prison and will be offered six monthly injections of VIVITROL for six months post release. Following prison release, participants will be seen for study visits and receive VIVITROL injections at Glenwood Life Counseling Center in Baltimore, MD. Participants will complete follow-up visits one and two months after the last VIVITROL injection. Participants will be assessed at 10 time points: at screening (study entry: approximately one month prior to release from prison), at baseline (approximately 1 week prior to release), and then monthly for 6treatment visits, an end of treatment visit and a safety follow-up visit following their release from prison. Adherence to VIVITROL, both in prison and in the community, will be assessed. The primary endpoint will be evaluated based on incidence of subject re-arrest as determined by review of official criminal justice records and self-report. The secondary endpoints will be evaluated based on incidence of subject re-incarceration as determined by review of official criminal justice records and self-report; drug abuse treatment program entry; retention in the community measured using the number of VIVITROL injections subjects receive in the community and if subject takes part in substance abuse treatment program; opioid overdose measured through relevant AEs and Opiate Overdose Form; opioid use measured using the Addiction Severity Index (ASI) and supplemental questionnaires, opioid overdose form, and urine drug tests; opioid craving assessed using the opioid craving visual analog scale (VAS); Cocaine use assessed using the ASI, supplemental questionnaires, and urine drug tests; and criminal activity assessed by review of criminal justice records and completion of the ASI and supplemental questionnaires. Quality-of-life (QoL) evaluated using EQ-5D questionnaires and HIV risk behaviors assessed by the Risk Assessment Battery (RAB) questionnaire will be assessed as additional efficacy endpoints. Parameters for evaluating safety will include vital signs, safety laboratory testing (hematology, chemistry and urinalysis) and AEs.

A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections

This five-year study has two aims: 1) To determine the willingness of the community corrections population to undergo HIV testing (Seek), 1a) To compare a strategy of rapid HIV testing on site in community corrections to referral to an off site community HIV testing location with a randomized control study (Test). 2) To determine whether people with HIV (both known and newly diagnosed) can be identified in community corrections; 2a) To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections; and 2b) To determine the impact of Project Bridge compared to Treatment as Usual on individuals with HIV recruited through community corrections on : 1) engagement in care; 2) retention in care; and 3) proportion of those prescribed Highly Active Antiretroviral Therapy (HAART) who are undetectable at 6 and 12 months using a pre-post analysis (Treat). A total of 6,000 male and female probationers and parolees in Baltimore City, Maryland (n=3,000) and Providence, Rhode Island (n=3,000) will be randomly assigned (within location and gender) 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) Referral by the research staff for rapid HIV testing off site at a community HIV testing site or community health center. The second study is a randomized trial of linkage to HIV care for HIV+ adults recruited through community corrections (probation and parole). All individuals identified by testing positive for HIV or self-reporting themselves as HIV-positive at community corrections will be offered enrollment in a one-year intervention study to examine the ability to improve linkage from no treatment into HIV care. A total of 240 HIV-positive participants (120 in Baltimore and 120 in Providence) will be randomly assigned to one of two conditions: 1) Project Bridge [PB] for 12 months; or 2) Treatment as Usual [TAU] (standard level of care/referral for treatment). Those HIV-positive participants randomized to treatment as usual that fail to engage in treatment (failure to engage in treatment during the three months previous to the 6-month assessment) will be offered a “rescue” opportunity to cross over to the Project Bridge intervention at their 6-month follow-up assessment. Those participants in TAU who refuse the “rescue” option of PB at 6 months will still be eligible for 12-month research follow-up assessments. All participants will be followed up at 3,6, and 12-months.

Buprenorphine for Prisoners

Prisoners with pre-incarceration heroin addiction histories rarely receive drug abuse treatment while incarcerated, or upon release. Re-addiction among such individuals typically occurs within one month of release, placing these individuals at disproportionately high risk for HIV and hepatitis B and C infections, overdose death, increased criminal activity, and re-incarceration. Research is clearly needed to evaluate the effectiveness of innovative drug treatment interventions spanning incarceration and the community. Based on substantial evidence of the effectiveness of opioid agonist treatment in the community, and the authors' considerable investigative experience with prison-initiated opioid agonist maintenance treatment of male inmates, this five-year study will examine the effectiveness of the administration of buprenorphine to previously-addicted inmates initiated in the institution and continued on release to the community. Moreover, this study will be the first to examine the effectiveness of opioid agonist therapy for female (n=160) as well as male (n=160) pre-release inmates with pre-addiction heroin addiction histories. Finally, this research will examine the extent to which the setting of post-release buprenorphine is provided [in an opioid agonist treatment program (OTP) vs. a community health center (CHC)]. Participants will be randomly assigned, within gender, to one of four treatment conditions: 1) buprenorphine and counseling in prison, with referral for continued treatment at an OTP upon release; 2) buprenorphine and counseling in prison, with referral for continued treatment at a CHC upon release; 3) counseling only in prison, with referral for buprenorphine and counseling at a OTP upon release; and 4) counseling only in prison, with referral for buprenorphine and counseling at a CHC upon release. Participants will be assessed at study entry and at 1, 3, 6, and 12 months following their release from prison. Outcome measures include: treatment entry and retention in the community, heroin use, cocaine use, HIV infection, HIV-risk behaviors, criminal activity, and employment.

CJ DATS 2: Implementing Treatment Initiatives for Criminal Justice Clients

This study is a collaborative multi-site implementation of Medication Assisted Treatment (MAT) in community corrections. This implementation study seeks to facilitate and enhance inter-organizational linkages and collaboration between CJ supervision settings (e.g. probation & parole) and community-based treatment settings where addiction pharmacotherapy is currently available within a given catchment area, while educating criminal justice employees about the effectiveness of MAT for individuals with opioid and/or alcohol dependence. The purpose of this implementation strategy is to improve the referral process of opioid- and alcohol-dependent adults under community supervision to ensure receipt of addiction pharmacotherapy when medically appropriate. By facilitating linkages to effective substance abuse treatment through closer collaboration among CJ agencies and treatment providers, significant benefits in terms of reducing adverse public health and public safety impacts, as well as benefits to the clients themselves, are likely to be achieved.

Entry into Comprehensive Methadone Treatment via Interim Maintenance

As a result of inadequate funding for treatment, waiting lists for opioid treatment programs (OTPs) persist, and new and more effective approaches for expanding treatment access and improving outcomes are needed. This competing renewal application seeks to build on our parent R01 study, which was the first randomized clinical trial of interim methadone treatment conducted under existing federal regulations. Research resulting from the parent study has demonstrated that interim treatment (methadone with only crisis counseling) in comparison to wait list control, was associated with greater entry into comprehensive OTPs, lower self-reported heroin and cocaine use, lower rates of opioid-positive drug tests, and lower rates of self-reported crime at both 4- and 10- month follow-up (Schwartz et al., 2006 and in press). A parallel two-group randomized study is proposed, in which adult heroin-dependent subjects (N = 300) who meet federal criteria for OTP entry and for whom no treatment slot is available, will be randomly assigned at three community-based OTPs to either interim methadone treatment or prompt admission to comprehensive methadone treatment. Following federal guidelines, all interim treatment subjects who have not gained entry into a comprehensive OTP by 120 days (4 months) from study entry will be admitted to comprehensive treatment. Outcome will be assessed by measuring enrollment in comprehensive treatment at 4 and 12 months from baseline, as well as participants' illicit drug use, HIV-risk behavior, and criminal activity at baseline and at 2, 4, and 12 months post-baseline. We hypothesize that prompt entry to comprehensive treatment will have outcomes superior to interim treatment. Furthermore, participants with lower motivation for treatment are hypothesized to respond more positively to interim maintenance than to comprehensive treatment, because of potentially aversive features of comprehensive treatment, particularly confrontation in counseling. Finally, a cost benefit analysis will be conducted to determine the related costs and benefits of interim treatment v.comprehensive treatment. The results of this study will provide important information to researchers, clinicians, and public health policymakers regarding the relative effectiveness and benefits of these two approaches to OTP treatment.

Intensive Outpatient v. Outpatient Treatment with Buprenorphine among African Americans

This two-group randomized clinical trial will test the effectiveness of intensive outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 3 formerly “drug-free” programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-months, and 6-months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success (e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their respective relationships to treatment experiences and treatment retention.

NIDA Clinical Trials Network, Mid Atlantic Node

The NIDA Clinical Trials Network (CTN) was founded in 1999 with six participating groups; it now has 16 participating groups, called Nodes, distributed throughout the US. Each node is comprised of a consortium of university-based researchers and directors of community-based drug abuse treatment clinics. The Mid Atlantic Node is led by Dr. Maxine Stitzer at the Johns Hopkins University and Dr. Robert Schwartz at Friends Research Institute and includes collaborations with Virginia Commonwealth University and Friends Research Institute, as well as a group of community treatment providers in Baltimore, Virginia and Washington, DC. This configuration is designed to promote and advance the three missions of the CTN: 1) to promote bi-directional communication between researchers and community treatment providers; 2) to conduct research on evidence-based interventions at community-based clinical sites to identify interventions with effectiveness in real world settings; and, 3) to promote dissemination and adoption of new evidence-based practices in order ultimately to improve treatment services nationwide. The CTN has now successfully conducted over 20 studies. Some have examined new medications such as buprenorphine for the treatment of opioid dependence; others have examined behavior therapies including motivational interviewing, contingency management and family-based therapy for adolescents. The results of completed studies can be found at: http://ctndisseminationlibrary.org. Further, to address the dissemination agenda, CTN and the national network of ATTC’s jointly sponsor a Blending Initiative to develop dissemination training packages for use of buprenorphine, motivational interviewing and contingency management (also called Motivational Incentives). These packages can be found on the ATTC website, www. nattc.org.

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.

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.

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.

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.

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