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Research Projects

Title: Buprenorphine for Prisoners
Principal Investigator: Timothy Kinlock, Ph.D.
Co-Investigator(s): Michael 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: 08/07 – 7/12

Project Description:   

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.

 

 

Title:

Drug Abuse Treatment Clinical Trials Mid Atlantic Node

Principal Investigator: Maxine Stitzer, Ph.D. (Johns Hopkins School of Medicine)
Co-Investigator(s): Robert Schwartz, M.D.
Project Manager:
Funded by: National Institute on Drug Abuse
Grant Number: U10 DA13034
Total Project Period: 10/99 – 9/09
Project Description:   

The drug abuse treatment 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 includes collaborations with Virginia Commonwealth University and Friends Research Institute, as well as a group of community treatment providers in Baltimore and Virginia.  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.

 

 

Title:

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
Project Description:

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.

 

 

Title: Engaging Detoxification Clients into Long-Term Treatment
Principal Investigator: Elizabeth Katz, Ph.D.
Co-Investigator(s): Barry Brown, Ph.D., Robert Schwartz, M.D.
Project Manager: Stuart King, B.S.
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA011402
Total Project Period: 8/04 – 7/09

Project Description: 

Developing effective strategies for engaging clients in treatment is a first responsibility of drug abuse programming.  Despite concerns about the inability of detoxification alone to promote sustained abstinence, little work has been done to develop strategies for engaging opiate users into long-term treatment following detoxification.  During the first grant period, drug-free treatment entrants receiving a single Role Induction (RI) session were found to be significantly more likely than those receiving Standard orientation to achieve three month retention and report greater treatment satisfaction (Katz et al., 2001; In Press).  RI was not, however, similarly effective with clients admitted to a three-day buprenorphine detoxification program at the same site (Katz et al., 2002).  The current grant is designed to assess the effectiveness of two strategies adapting the RI model, found effective with drug-free outpatient clients, to the special circumstances of detoxification.  Intensive Role Induction (IRI) will involve an initial RI session augmented by additional RI sessions to permit initial preparation for detoxification, and later preparation for transition to long-term treatment.  IRI + Case Management will involve IRI in conjunction with efforts to access community resources that are significant to the client's well-being and retention in treatment. The two experimental interventions will be compared to routine treatment provided detoxification clients at the outpatient program.  Participants will be recruited from applicants to a 30-day buprenorphine detoxification program.  Baseline measures will be administered prior to random assignment. Follow-up will occur at one and three months with a primary emphasis on measures of consecutive days retained and retention to 90 days as criteria of treatment engagement, and at six and twelve months with a primary emphasis on drug use, crime, and employment as measures of treatment outcome.  We will also be concerned with session attendance, program satisfaction, counselor ratings, motivation for treatment and behavior change, and hopelessness in addition to the primary measures of treatment engagement; and measures of HIV/AIDS risk behaviors and psychological functioning in addition to primary measures of treatment outcome.  It is expected that the experimental interventions will be more effective than the Standard Treatment for measures of treatment engagement during the first three months of follow-up, and more effective than the Standard Treatment for measures reflecting behavior change administered at six- and 12-month follow-up.  Findings from this study are seen as having relevance for strategies to engage and retain detoxification clients in long-term treatment regardless of the pharmacological agent employed.

 

 

Title: 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

Project Description:   

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.

 

 

Title: 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

Project Description: 

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.

 

 

Title:  Prevention of Relapse to Opioid Addiction using Long-acting Injectable Naltrexone
Principal Investigator: Timothy Kinlock, Ph.D.
Co-Investigator(s): Michael Gordon, D.P.A. , Robert Schwartz, M.D.
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA024550-01A1
Total Project Period: 7/08 – 5/13

Project Description: 

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.

 

 

Title: 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 – 11/11

Project Description: 

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.

 

 

Title: Substance Abuse, HIV/AIDS, and Hepatitis Prevention in urban Native Americans
Principal Investigator: Diana H. Caldwell, M.P.A.
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

Project Description: 

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.

 

 
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