Social Research Center

Recently Completed Research Projects

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

Principal Investigator: Michael S. Gordon, D.P.A. (Primary Contact)
Co-Investigator(s): Timothy W. Kinlock, Ph.D.
Frank J. Vocci, Ph.D.
Terrence T. Fitzgerald, M.D., (Medical Director, Glenwood Life Counseling Center)
Project Manager: Kathryn Couvillion
Funded by: Alkermes
Grant Number: ALK21-028
Total Project Period: 12/11 – 2/14

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.

Buprenorphine for Prisoners

Principal Investigator: Timothy W. Kinlock, Ph.D.
Co-Investigator(s): Michael S. Gordon, D.P.A., Robert Schwartz, M.D.
Project Manager: Michael Gordon, D.P.A.
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA021579
Total Project Period: 8/07 – 7/13

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

Principal Investigator: Timothy W. Kinlock, Ph.D.
Co-Investigator(s): Michael S. Gordon, D.P.A., Frank J. Vocci, Ph.D.
Funded by: National Institute on Drug Abuse
Grant Number: IU01DA025233-01A1
Total Project Period: 8/09 – 7/13

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 and Engagement in Methadone Maintenance Treatment

Principal Investigator: Robert Schwartz, M.D.
Co-Investigator(s): Barry Brown, Ph.D.
Project Manager: Sharon Kelly, Ph.D.
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA015842
Total Project Period: 6/04 – 5/09

The majority of individuals in need of drug abuse treatment remain untreated, and a sizeable proportion of drug abusers who enter treatment exit after a brief tenure. Thus, research that contributes toward an understanding of drug abusers’ entry and engagement in drug abuse treatment, and their subsequent outcomes, is critical to efforts to improve treatment. Given the threat of HIV infection, improving treatment entry and engagement is particularly important with regard to opioid addicts, who are at especially high risk for HIV infection, and methadone maintenance treatment, which is widely used for the treatment of opioid dependence. This five-year services research study comprehensively examines treatment entry and engagement, using a biopsychosocial theoretical perspective to guide the investigation. Informed by this perspective, the proposed study will examine three domains - namely, personal characteristics, treatment attributes, and environmental influences - that are hypothesized to affect opioid addicts’ motivation to change and motivation for treatment, their entry into and subsequent engagement in methadone maintenance treatment, and, ultimately, their recovery. Within each of these domains, the effects of specific, potentially relevant variables, selected on the basis of previous research and theory, will be examined. Two groups of adult opioid addicts will be studied, including addicts who are not currently in nor interested in seeking treatment (N = 200) and opioid addicts newly admitted to methadone maintenance treatment (N = 400), with both groups involved in the examination of treatment entry, and the admission group alone involved in the examination of treatment engagement.comprehensive assessments will be conducted at baseline and 3 months (the 3-month assessment involving only the admission group to study their initial engagement in treatment), and 6 and 12 months thereafter. Two separate, but complementary, structural equation models are posited to predict (1) treatment entry and (2) treatment engagement and outcomes. These models, along with hypothesized components of these models, will be tested using structural equation modeling techniques, including the comparison of hypothesized models with plausible alternate models. While the primary study approach is quantitative, a strong qualitative research component will be included to provide for in-depth examination of motivation to change and motivation for treatment, and of other variables that emerge in the quantitative research as being important for understanding treatment entry and engagement.

Entry into Comprehensive Methadone Treatment via Interim Maintenance

Principal Investigator: Robert Schwartz, M.D.
Co-Investigator(s): Jerome H. Jaffe, M.D., Sharon Kelly, Ph.D.
Project Manager: Sharon Kelly, Ph.D.
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA13636
Total Project Period: 04/07 – 12/10

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

Principal Investigator: Shannon Gwin Mitchell, Ph.D.
Co-Investigator(s): Jerome H. Jaffe, M.D., Yngvild K. Olsen, M.D.
Project Manager: Jan Gryczynski, M.A.
Funded by: National Institute on Drug Abuse
Grant Number: 1RC1DA028407-01
Total Project Period: 09/09 – 08/11

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.

Risk Factors for HIV Among Urban African American Youth

Principal Investigator: Steven Carswell, Ph.D.
Co-Investigator(s): Thomas Hanlon, Ph.D.
Funded by: National Center on Minority Health and Health Disparities
Grant Number: 4R00 MD002271
Total Project Period: 12/08 – 11/12

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.

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

Principal Investigator: Diana H. Caldwell, Ph.D.
Project Manager: Jan Gryczynski, M.A.
Funded by: Substance Abuse and Mental Health Services Administration
Grant Number: SP 133321
Total Project Period: 10/05 – 9/10

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.

The Effects of Manualized Treatment in a Seamless System

Principal Investigator: Faye Taxman, Ph.D.
Co-Investigator(s): Monique Wilson, Dr.P.H.
Project Manager: Meda Barker, M.S.
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA017729
Total Project Period: 8/05 – 7/10

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.