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Research
The UCLA Integrated Substance Abuse Programs (ISAP) conducts research,
provides research training and clinical training, and arranges treatment
for substance abuse disorders in coordination with the UCLA Department
of Psychiatry and Biobehavioral Sciences and in affiliation with other
community-based treatment providers. ISAP efforts span the spectrum of
scientific and clinical activities pertinent to the investigation and
amelioration of substance abuse and related consequences. ISAP work ranges
from epidemiological and policy studies to basic science and human laboratory
programs to clinical trials of treatments involving innovative behavioral
and pharmacological approaches.
UCLA Integrated Substance Abuse Programs
Methamphetamine Studies
Updated February 2008
Double-Blind, Placebo-Controlled Trial of Modafinil for the
Treatment of Methamphetamine Dependence
October 2006 to June 2008
Richard A. Rawson, Ph.D., Principal Investigator (rrawson@mednet.ucla.edu)
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.
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Motivational Therapy for Stimulant Users with Depression
September 2007-August 2008
Suzette Glasner-Edwards, Ph.D., Principal Investigator (sglasner@ucla.edu)
This study examines the incremental efficacy of an aftercare psychosocial
treatment program of a motivational intervention combined with cognitive
behavioral therapy (CBT), relative to standard care or treatment as usual
(TAU) for individuals with stimulant dependence and comorbid major depressive
disorder. Although the past decade has seen new cognitive and motivational
interventions producing improvement in substance use outcomes, few studies
have systematically explored the efficacy of these approaches in combination
in patients with substance use disorders and comorbid mental health disorders.
The proposed randomized trial will include 80 dually diagnosed individuals
with stimulant dependence and a substance-independent diagnosis of Major
Depressive Disorder. In patients receiving pharmacotherapy for depression,
we will compare 12 weeks of CBT combined with motivational therapy (CBT-MT)
to 12 weeks of TAU on 6, 12, 24, and 36 week outcomes for depression,
substance use, HIV-risk behaviors, and other healthcare outcomes. The
primary hypothesis is that CBT-MT will produce better outcomes than TSF.
We will also examine predictors of early attrition and treatment retention
and examine neuropsychological predictors of treatment retention and
outcome. The results of this study might provide a dual-diagnosis specific,
cognitive- motivational alternative to traditional aftercare programs
for the treatment of stimulant users with depression.
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Two Models of Telephone Support for Stimulant Recovery
August 2005 through July 2010
David Farabee, Ph.D., Principal Investigator (dfarabee@ucla.edu)
The purpose of this study is to develop and compare the efficacy of four
low-cost, telephone support protocols for patients who have completed
the intensive phase of a structured, outpatient stimulant abuse treatment
protocol. Patients (N = 500) who have successfully completed
the 4-month Matrix Outpatient Model of stimulant abuse treatment are
randomly assigned to one of five aftercare counseling conditions: (1)
unstructured/non-directive, (2) unstructured/directive, (3) structured/non-directive,
(4) structured/directive, or (5) standard referral to aftercare without
telephone counseling (control). The two structured conditions are based
on the behavioral “prompts” identified by Farabee et al.
(2002) as being associated with drug avoidance. In the non-directive
conditions, patients state their own goals and how they intend to achieve
them. In the directive conditions, the coaches provide specific recommendations
for the adoption of as many drug-avoidance activities as possible. Certain
patient personality traits or styles are also assessed for their possible
interaction with the telephone counseling dimensions. Outcomes will be
tracked at 6 and 12 months following completion of primary treatment
and will include measurement of participation in drug-avoidance activities
(including aftercare participation), as well as self-reported and objective
measures of substance use and associated prosocial behavior change.
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Prenatal Methamphetamine Exposure and Child Development
September 2001 through August 2007
Barry Lester, M.D., Brown University, Principal Investigator
Richard A. Rawson, Ph.D., Co-Investigator (rrawson@mednet.ucla.edu)
Despite the fact that methamphetamine (MA) use is very high in some regions,
little is known about the potential neurotoxic effects of prenatal MA
exposure on the development of children. The IDEAL (Infant Development,
Environment and Lifestyle) study was initiated to study these effects.
The investigators enrolled 1,618 mothers at four clinical centers in
cities where MA use was known to be a problem, Los Angeles, Des Moines,
Tulsa, and Honolulu, and identified 84 newborns who were exposed to MA
in utero, and 1,534 who were not exposed. The investigators looked at
neonatal birth weight and gestational ages in weeks. They also looked
at the relationship between MA exposure and the rate of small-for-gestational-age
births. The study found that the children who were exposed in utero to
MA were 3.5 times more likely than unexposed children to be small for
their gestational age. MA-exposed infants were also more likely to be
born pre-term (less than 37 weeks gestation). In all, 12.5% of the drug-exposed
infants were born pre-term, compared with 6.5% of those who were not
exposed (P = 0.036). Mothers who used MA were more likely to
have a lower socioeconomic status, live in a household earning less than
$10,000 per year, be on Medicaid, live without a partner, and were more
likely not to have finished high school. They also tended to be younger,
to seek prenatal care later in pregnancy, have fewer visits for prenatal
care, and, somewhat surprisingly, to gain more weight during pregnancy
relative to non-users. The latter finding reflects the fact that those
who quit MA use earlier in gestation gained 10 pounds more than those
who continued to use MA throughout their pregnancy, suggesting that the
anorexic effects of MA are limited to continuous use. For more information,
see Smith, L.M., et al. (2006). The Infant Development, Environment,
and Lifestyle Study: Effects of prenatal methamphetamine exposure, polydrug
exposure, and poverty on intrauterine growth. Pediatrics, 118(3),1149-1156.
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METH INSIDE OUT Video Series
June 2007 to June 2009
Thomas Freese, Ph.D., Principal Investigator (tefreese@ix.netcom.com)
METH INSIDE OUT is a groundbreaking video-based treatment
curriculum on methamphetamine addiction and recovery. The series is designed
to equip meth users, their families and the professionals who assist them with
a solid understanding of the neurological basis of addiction, effective tools
for recovery, and, most importantly, hope for the future. Presented by UCLA,
the world leaders in methamphetamine research, and Eyes of the World Media
Group, this research-based series presents the most up-to-date information
in a compelling and easy-to-understand format. METH INSIDE OUT emphasizes
the human impact of addiction by sharing personal stories of users and their
families. Shot in high definition with state-of-the-art graphics, the series
goes beyond presenting information by engaging and inspiring viewers. Created
for maximum flexibility, the curriculum is designed to meet the needs of treatment
centers, jails/prisons, community centers, social service agencies and universities.
The series is comprised of five episodes, which can be used individually or
as a set. Companion Leader’s Guides allow counselors to maximize the
educational potential of each episode. After an initial overview episode (The
Complete Picture), each subsequent episode focuses on a critical set of
topics: the brain and behavior (Brain & Behavior), the body (The
Physical Reality), family (Rebuilding Relationships), and treatment
(Windows to Recovery).
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Methamphetamine Abuse, Inhibitory Control: Implications for Treatment
September
2006 - April 2010
Edythe D. London, PhD, Principal Investigator
Despite advances in the
scientific understanding of drug abuse and dependence, effective treatments
are lacking, and new therapies for these disorders are urgently needed.
The proposed P20-funded Developmental Center for Translational Research
on Addictions will address this need by integrating preclinical studies
to directly inform clinical research on drug addiction, and complementarily,
leveraging clinical insights to help target basic science approaches.
The proposed Center links basic scientists who have made significant
contributions to knowledge of the neurobiological components of addiction
with clinical investigators who are at the forefront in treatment research.
The theme of the developmental center will be impaired inhibitory control
as a therapeutic target for methamphetamine (MA) dependence. We made
this choice because of: a) the magnitude of the MA abuse problem worldwide;
b) the severity of its consequences; c) the lack of an effective treatment
for MA dependence; d) the importance of impaired inhibitory control to
drug addiction; and e) our leadership in advancing the understanding
and treatment of MA abuse. With this initial focus, we propose four interrelated
projects to characterize impairments in response inhibition consequent
to methamphetamine (MA) exposure at behavioral, neural systems, and neurochemical
levels in both human and animal models, and to assess the pharmacological
modulation of these deficits. The four research projects in this P20
Center aim: 1) to delineate the neural circuitry underlying deficits
in inhibitory control in MA-dependent human subjects; 2) to relate deficits
in inhibitory control to drug-taking behavior using a human laboratory
model of MA self-administration; 3) to establish and characterize (behaviorally
and neurochemically) a non-human primate model for investigating inhibitory
control deficits characteristic of MA abuse; and 4) to characterize regional
brain neurochemical effects of pharmacological manipulations aimed at
modulating response inhibition in a rodent model for MA dependence. The
four projects are integrated in a way that would not be feasible if each
project had been designed to be a discrete study, outside the Center
environment. The Center will support these scientific projects with the
over-arching goals of creating an environment for interdisciplinary translational
research, whereby the flow of information from basic research in animal
models and human laboratory studies can be rapidly applied to development
of treatments for drug abuse, and developing a program of research career
development that will coordinate and enhance existing training programs,
providing multiple, excellent opportunities for pre- and postdoctoral
fellows and faculty to initiate new projects focusing on translational
approaches to studies of the neurobiology of drug abuse.
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HIV Prevention for Heterosexual Methamphetamine Users in Drug
Treatment
September 2005 – August 2007
Mary-Lynn Brecht, Principal Investigator
This study is using personal interviews to collect data on HIV and injection
risk behaviors, risk-related information/skills, risk-seeking, impulsivity,
and resistance to coercion in a sample of 400 methamphetamine-using offenders
referred to drug treatment in Kern County, CA. Analyses will describe
HIV risk behaviors and test relationships between these behaviors and
psychosocial factors, risk-seeking, impulsivity, and resistance. Because
drug treatment offers a prime opportunity for intervention aimed at prevention
of HIV risk behavior, this pilot study is examining patterns of these
behaviors in order to form a basis for developing interventions tailored
for this population.
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Methamphetamine Abuse: Natural History, Treatment Effects
February 1998 – July 2005
Mary-Lynn Brecht, Principal Investigator
This study addresses specific aims in three areas: (1) assessment of
methamphetamine (MA) use patterns over time and the long-term consequences
of MA use, including the conditional impact of demographic, background,
and health characteristics, and the relationships of MA-use histories
to other substance use, HIV/AIDS risk behaviors, and criminal behaviors;
(2) examination of long-term treatment outcomes (including differential
effects for ethnicity, gender, modality, and other user characteristics)
and patterns of treatment utilization for MA users; and (3) description
of motivation, addiction severity, and other barriers limiting treatment
access for MA users who have not participated in treatment. Using the
Natural History Interview (NHI), the study interviewed a sample of 365
MA users admitted to treatment for MA use in 1995-1997 to publicly funded
outpatient and residential programs in Los Angeles County; a 3-year follow-up
interview was also completed on this treated sample in order to understand
longer-term treatment outcomes.
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Women, Methamphetamine, and Sex
April 2006 – March 2011
Alison H. Brown, Principal Investigator
This is a mixed methods study of women methamphetamine (MA) users' sexual
experiences and behaviors. It involves longitudinal in-depth qualitative
interviews with 30 women MA users and secondary analysis of data on risk
behaviors among women MA users. Considering that women who abuse substances
such as MA typically have multiple factors (e.g., histories of violence
and abuse) placing them at risk for poor sexual decision-making, a more
in-depth understanding of how women MA users conceptualize their sexual
behaviors and experiences could assist in developing interventions for
this group of women.
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Methamphetamine Dependence: Treating Neurocognitive Impairment
September 2005 – September 2006
Ari Kalechstein, Principal Investigator
Over the past several years, investigators of the UCLA Integrated Substance
Abuse Programs (ISAP) have built upon clinical experience gained from
providing treatment for methamphetamine-dependent individuals to develop
a human laboratory program aimed at assessing the neurobiological consequences
of methamphetamine exposure. Current research designs at ISAP and
other research groups focus on the evaluation of methamphetamine-dependent
individuals following abstinence initiation. While these studies
are important, they do not utilize neurocognitive impairment as a marker
for determining the extent of methamphetamine-associated neurotoxicity. Because
impaired neurocognitive functioning is associated with poorer functional
outcomes (e.g., employment status, treatment outcome), reversal of these
impairments could enhance the quality of treatments for methamphetamine
dependence.
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Double-Blind, Placebo-Controlled Trial of PROMETA© Pharmacotherapy
for the Treatment of Methamphetamine
March 2005 – January 2007
Walter Ling, Principal Investigator
This study assesses the efficacy of the PROMETA© pharmacotherapy
compared to placebo for initiating abstinence and for preventing relapse
to methamphetamine use in treatment-seeking individuals meeting criteria
for methamphetamine abuse in multiple treatment locations. The
study design includes random assignment to pharmacotherapy condition,
and both participants and study personnel are blinded to assigned condition.
Screening verifies participant eligibility and collects demographic,
drug use, psychiatric and neuropsychological information, before participants
are randomly assigned to either the PROMETA© pharmacotherapy condition
(n=45) or to the placebo condition (n=45).
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Phase I, Double-Blind, Placebo-Controlled Assessment
of Potential Interactions Between Intravenous Methamphetamine and Aripiprazole
January 2003 – January 2008
Thomas Newton, Principal Investigator
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