Newly Funded ISAP Research Projects
(Funding awarded since July 2006)
Double-Blind, Placebo-Controlled Trial
of Modafinil
for the Treatment of Methamphetamine Dependence
(Project Category: Clinical Trials and Medication Development)
Richard A. Rawson, Ph.D., Principal Investigator
(rrawson@mednet.ucla.edu)
Donnie W. Watson, Ph.D., & Mark Hrymoc, M.D., Co-Investigators
Valerie Pearce, B.A., Project Director
This double-blind, multicenter, placebo-controlled, randomized, parallel group design study on methamphetamine-dependent outpatients is coordinated through the Department of Veterans Affairs and the Cooperative Studies Program Coordinating Center. Subjects (N = 210) with DSM-IV criteria for methamphetamine (MA) dependence will be randomized to one of three treatment arms. Subjects will receive 200 mg modafinil, 400 mg modafinil or matched placebo daily for 12 weeks, with a follow-up assessment 4 weeks after treatment completion/termination. All subjects will receive standardized manual-guided cognitive behavioral therapy (CBT) three times a week during the 12-week study drug administration period. Randomization to treatment groups will be done by stratifying by clinical site then using an adaptive randomization procedure based on ADHD, gender, and frequency of historical self-report of MA use in the 30 days prior to informed consent (£ 18 vs. >18).
The modafinil protocol will be conducted by investigators associated with eight organizations: UCLA/Friends Research Institute, Torrance, California; Matrix Institute on Addictions, Tarzana, California; South Bay Treatment Center, San Diego, California; University of Colorado Health Sciences Center, Denver; Iowa Health Systems (Office of Research, Lutheran Hospital), Des Moines; Salt Lake City Health Care System, Utah; START Research & Treatment, Kansas City, Missouri; and University of Hawaii (Queens Hospital) Honolulu. This study is a preliminary assessment to evaluate the efficacy and safety of modafinil in reducing MA use in subjects with MA dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of MA non-use weeks over time as measured by quantitative urine analysis for MA.
Double-Blind, Placebo-Controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence was funded by the National Institute on Drug Abuse, Grant NIDA-CSP-1026 (October 2006 to June 2008).
Effectiveness of Residential vs. Intensive
Outpatient Prison-Based Treatment
(Project Category: Criminal Justice Populations)
William Burdon, Ph.D., Principal Investigator (wburdon@ucla.edu)
The purpose of this 5-year is to (1) assess the differential clinical effectiveness and cost-effectiveness of long-term residential (LTR) treatment versus intensive outpatient (IOP) treatment in a prison-based treatment setting and (2) determine whether one treatment modality is more effective than the other for drug-involved offenders matched to the appropriate modality (e.g., based on risk level and/or substance abuse severity).
Eight hundred inmates (600 males and 200 females) who have received referrals to enter prison-based substance abuse treatment will be randomly assigned to either LTR or IOP treatment. Inmates who are randomly assigned to LTR treatment will begin treatment no later than 9 months prior to their scheduled release date. Inmates who are randomly assigned to IOP treatment will begin treatment approximately 3 months prior to their scheduled release from prison. Treatment for both groups will continue until they are released from prison. Study participants will be assessed in face-to-face interviews at baseline and immediately prior to discharge from the treatment programs and release from prison. Twelve-month post-release follow-up interviews will also be conducted. Data on community treatment participation (e.g., modality, intensity, and duration of treatment) will be obtained directly from the community provider. In addition, the Washington State Department of Corrections (WSDOC) will provide records-based data on post-release treatment participation, illicit drug use (i.e., results of drug tests), and return-to-custody for all individuals who receive in-custody IOP and LTR treatment.
This project will be conducted in collaboration with the Washington State Department of Corrections (WSDOC) and CiviGenics, Inc., the sole provider of treatment services for inmates in the Washington State prison system.
Effectiveness of Residential vs. Intensive Outpatient Prison-Based Treatment was funded by the National Institute on Drug Abuse, Grant 1 R01 DA020621 (September 2006 to May 2011).
Enhancing Substance Abuse Treatment Services
for Women Offenders
(Project Category: Criminal Justice Populations)
Nena Messina, Ph.D., Principal Investigator
(nmessina@ucla.edu)
Maria Zarza, Ph.D., Project Director
This 3-year study will examine Mental Health Systems, Inc.’s (MHS), readiness and capacity for practice improvement as it incorporates women-focused treatment into four MHS program sites currently serving female drug court participants. The proposed study will also include an experimental component to determine the relative effectiveness of a women-focused (WF) treatment program based on relational theory compared to the standard mixed-gender (MG) outpatient treatment program delivered to women offenders deferred from incarceration through drug court to promote positive behaviors (e.g., HIV risk reduction and substance abuse, and increased psychological functioning). The WF curriculum has been fully developed (Helping Women Recover, Covington, 1999; 2003); however, the activities outlined in this application will be the first empirical test of the curriculum that includes assessments of staff readiness and barriers to enhancing service. Specifically, 150 women participating in four MHS drug court programs in San Diego, California, will be randomly assigned to the WF or MG treatment program groups. The proposed study has the following specific aims:
- To identify and address barriers to coordinating and integrating new and appropriate WF services, including HIV prevention, for substance-dependent women offenders;
- To coordinate and integrate a theoretically based women-focused protocol into the existing MHS program curriculum;
- To develop effective fidelity measures to assess staff performance, adherence, and retention of the newly integrated curriculum;
- To pilot test the efficacy of the theoretically based, multi-faceted, WF curriculum to promote positive behaviors among women offenders compared to the impact of the standard MG program;
- To qualitatively assess women’s perceptions of their treatment experience, comparing those of women in the newly integrated WF program and those of women in the standard MG program.
Enhancing Substance Abuse Treatment Services for Women Offenders was funded by Mental Health Systems, Inc., Grant 720 (R01 DA022149) (September 2005 to July 2009).
Evaluation of Community Bridges Project
(Project Category: Special Populations and Topics)
Christine E. Grella, Ph.D., Principal Investigator
(grella@ucla.edu)
Anne Bellows, M.S.W., Project Director
The purpose of the Community Bridges Project is to strengthen and enhance the comprehensive treatment system in Santa Monica, California, for chronically homeless persons who have co-occurring mental illness and substance use disorders. The project plans to develop a fully integrated system and treatment model for this population through collaboration among service providers that include substance abuse treatment, mental health treatment, health services, shelter and drop-in services, and transitional and permanent housing. The integrated treatment model will incorporate several evidence-based practices, including motivational interviewing and relapse prevention, with the aim of (1) increasing access to treatment, (2) increasing continuity of care and services integration, (3) improving quality of life and increasing self-determination, and (4) improving levels of functioning among participants. In addition, the project aims to increase integration of services across the participating providers, to eliminate barriers to system entry, and to improve staff competency in treating homeless individuals with co-occurring disorders. ISAP will conduct the project-level process and outcome evaluations and participate in the national cross-site evaluation activities.
Evaluation of Community Bridges Project was funded by the Clare Foundation (Grant 20063816), through a grant from the Substance Abuse and Mental Health Services Administration (SAMHSA; September 2006 to September 2011).
Evaluation of the Substance Abuse and
Crime Prevention Act of 2000
(Project Category: Criminal Justice Populations)
Darren Urada, Ph.D., Principal Investigator
(durada@ucla.edu)
Angela Hawken, Ph.D., Co-Investigator
Liz Evans, M.A., & Bradley Conner, Ph.D., Project Directors
In November 2000, 61% of California voters approved Proposition 36, subsequently enacted into law as the Substance Abuse and Crime Prevention Act, or SACPA. This legislation mandated a major shift in the state’s criminal justice policy. Under SACPA, nonviolent drug possession offenders may choose to receive drug abuse treatment in the community instead of being sentenced to a term of incarceration or being placed under community supervision without treatment. ISAP is conducting a statewide evaluation of SACPA to examine its implementation, costs and cost-savings, and influence on offender behavior. The evaluation will examine SACPA’s effect on eligible offenders and subpopulations of eligible offenders as well as make recommendations for improvements. The evaluation will communicate findings to state and national audiences and identify implications for criminal justice and treatment policy. (Additional information is available at www.uclaisap.org/prop36/index.html.)
Evaluation of the Substance Abuse and Crime Prevention Act of 2000 was funded by the California Department of Alcohol and Drug Programs, Contract 06-00156 (February 2007 to November 2007).
Maternal HIV: Intervention to Assist
Disclosure to Children
(Project Category: HIV/AIDS)
Debra A. Murphy, Ph.D., Principal Investigator
(dmurphy@mednet.ucla.edu)
Mary-Lynn Brecht, Ph.D., Co-Investigator
Diana Payne, Ph.D., Project Director
This small 3-year R01 was designed to develop and pilot test an intervention to assist mothers living with HIV (MLWH) to disclose their serostatus to their young (age 6 – 12 years old) children. Information gathered in previous two R01s will be used to develop a brief disclosure intervention to assist HIV-infected mothers of young children to appropriately disclose their serostatus to their child. Feasibility, acceptability, and preliminary efficacy of the intervention will be tested in a pilot trial. MLWHs (N = 80) will be randomly assigned to the intervention or control condition. MLWHs and children will be assessed at baseline, 3-, 6-, and 9-month follow-ups. A random subset of intervention mothers (n = 12) will be asked to participate in an in-depth qualitative interview after their last follow-up to obtain detailed information on their experiences in the study. The aims of the intervention are to: facilitate disclosure of the MLWHs’ HIV status to their children; increase their self-efficacy to responding to children’s questions regarding HIV; reduce fears regarding disclosure and stigma; improve maternal knowledge of child development and how to provide age-appropriate levels of information; improve MLWHs’ mental health indicators over time; improve children’s mental health indicators over time; and improve family functioning indicators.
Maternal HIV: Intervention to Assist Disclosure to Children was funded by the National Institute of Mental Health, Grant 1 R01 MH077493 (January 2007 to December 2009).
Optimizing Outcomes Using Suboxone for
Opiate Dependence
(Project Category: Clinical Trials and Medication Development)
Walter Ling, M.D., Principal Investigator
(lwalter@ucla.edu)
Maureen Hillhouse, Ph.D, & Richard Rawson, Ph.D., Co-Investigators
Jessica Jenkins, M.S., Project Director
This study is a randomized controlled trial that will test the comparative efficacy of several approaches combining psychosocial treatment with pharmacotherapy for treatment of opioid dependence. In conjunction with buprenorphine pharmacotherapy, psychosocial treatment conditions will include a Cognitive Behavioral Therapy (CBT) condition with medical management (MM), a Contingency Management condition (CM) with MM, a combined CBT+CM condition with MM, and a standard MM condition with neither CBT nor CM, which approximates what physicians do in general when prescribing buprenorphine in their office practice to patients with opioid dependence. Eligible participants will be stabilized on the study drug for a period of 2 weeks and will then be randomly assigned to one of the four conditions for 16 weeks. This first period will be followed by a second 16-week period during which all participants will continue to receive buprenorphine treatment but will not engage in any psychosocial treatment as part of continued study participation. Medical management of the participants will be identical to that delivered during the first treatment phase. At the end of this second 16-week buprenorphine-only treatment period, participants will be tapered off buprenorphine within a maximum of 6 weeks, or will receive referral for continued treatment if unable to successfully complete the taper. Participants will again be assessed at 40-weeks and 52-weeks post-entry into the study. Participants will be 240 opioid-dependent males and non-pregnant, non-lactating females of all racial/ethnic groups who are at least 15 years of age.
Optimizing Outcomes Using Suboxone for Opiate Dependence was funded by the National Institute on Drug Abuse, Grant 1 R01 DA020210 (September 2006 to May 2011).