| Research
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UCLA Integrated Substance Abuse Programs (Cont'd)
Methamphetamine Studies
Updated February 2008
Phase I, Interaction Clinical Trial with
Bupropion and Methamphetamine
January 2003 – January 2008
Thomas Newton, Principal Investigator
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Phase II, Double-Blind, Placebo Controlled
Trial of Bupropion for the Treatment of Methamphetamine Dependence
January 2003 – January 2008
Richard A. Rawson, Principal Investigator
The NIDA Methamphetamine Clinical Trials Group (MCTG) established five
clinical research sites coordinated by UCLA researchers where medications
with potential value for methamphetamine (MA) users will be tested. This
study is a preliminary assessment of the efficacy and safety of bupropion
in reducing MA use in subjects with MA dependence. It is hypothesized
that bupropion treatment, compared to placebo, will be associated with
fewer days of MA use as measured by quantitative urine analysis for MA.
Results are in review for publication.
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UCLA Medication Development Unit for
Stimulant Abuse
September 2004 – February 2010
Walter Ling, Thomas Newton, Richard Rawson, Steven Shoptaw, Principal
Investigators
The UCLA Medication Development Unit for Stimulant Abuse is a NIDA-funded
research center dedicated to the development of medications to treat
methamphetamine dependence. The center supports several research clinics
throughout the Los Angeles area as well as a biostatistical/clinical
trials methodology core. Phase I and phase II clinical trials of prospective
medications that have been completed by the center or are currently underway
include trials of amantadine, baclofen, gabapentin, selegiline, cabergoline,
sertraline, DHEA, bupropion, vigabatrin, and modafinil.
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Methamphetamine Abuse Treatment--Special
Studies
September 2001 – March 2007
Patricia Marinelli-Casey, Principal Investigator
This is a collection of research studies that examines the long-term
consequences of methamphetamine dependence, the temporal trends in adherence
to a manualized treatment model, and the costs of various treatment approaches.
The MAT-SS project builds on the work conducted by the Methamphetamine
Treatment Project (MTP), the largest randomized clinical trial of treatments
for methamphetamine dependence to date. The MTP was conducted as an eight-site
outpatient trial, with ISAP serving as the Coordinating Center. There
are three separate studies included in the current MAT-SS project:
• The Multiyear Follow-up
Study assesses a cohort of participants who were enrolled in
the MTP by conducting follow-up interviews at 3-years post-intake.
The purpose of the study is to examine patterns and consequences
of methamphetamine abuse over time.
• The Treatment Adherence
Study contributes to knowledge about integrating research-based
therapies into practice by assessing adherence to a manualized treatment
as a function of time.
• The Cost Analysis Study evaluates
and compares the cost of a manualized treatment approach (Matrix Model)
to other locally available treatment approaches studied in the MTP.
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Methamphetamine Treatment Project
M. Douglas Anglin, Ph.D., Principal Investigator
Methamphetamine Treatment
Project (MTP) is the largest randomized clinical trial of treatments
for methamphetamine (MA) dependence to date. The objective of the study
was to compare the Matrix Model, a manualized treatment method, with
Treatment-As-Usual (TAU) in eight community outpatient settings in the
Western United States and to establish the cost and cost-effectiveness
of the Matrix approach, compared with the locally available treatments.
It also explored the replicability of the Matrix Model and problems involved
in technology transfer. Over an 18-month period between 1999 and 2001,
978 treatment-seeking, MA-dependent persons were randomly assigned to
receive either TAU at each site, or a manualized 16-week treatment (Matrix
Model). The participants were assessed at baseline, weekly during treatment,
at discharge, and at 6-month, and 12-month follow-up. The study was conducted
as an eight-site outpatient trial, with six sites located in California
and one each in Montana and Hawaii. The study results showed that individuals
assigned to treatment in the Matrix approach received substantially more
treatment services, were retained in treatment longer, gave more MA-negative
urine samples during treatment and completed treatment at a higher rate
than those in the TAU condition. These in-treatment data suggested a
superior response to the Matrix approach. When data at discharge and
follow up were examined, it appeared that both treatment conditions produced
comparable post-treatment outcomes. Participants in both conditions showed
very significant reductions in MA use, significant improvements in psychosocial
functioning, and substantial reductions in psychological symptoms, including
depression. Follow up data indicated that over 60 percent of both treatment
groups reported no MA use and gave urine samples that tested negative for MA (and cocaine) use. Use of other drugs, such as alcohol and marijuana
were also significantly reduced. A particularly interesting finding was
that across the 8 treatment sites, the ‘drug court site’,
e.g., the one that enrolled individuals who were participating under
a drug court program, produced superior results compared to the other
7 sites, suggesting a substantial beneficial influence of drug court
involvement. Overall, this evaluation is the largest controlled study
of MA treatments that has yet to be conducted.
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Children Exposed to Methamphetamine Use and
Manufacture
August 2005 – May 2007
Nena Messina, Principal Investigator
This is a 2-year pilot study to analyze existing Los Angeles drug-endangered
children case data to enhance our understanding of the extent, epidemiology,
and medical (e.g., respiratory, dental, dermatological, etc.) and developmental
(e.g., cautions or delays) problems of drug-exposed children, as well
as child-welfare case management services, treatment, and placement for
these children. The study will provide the basis for ongoing and expanded
research applications on drug-endangered children state- and nationwide.
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Assessment of Stress Effects in Methamphetamine
Dependence
September 2005 – August 2010
Thomas Newton, Principal Investigator
The purpose of this behavioral outpatient study is to determine the effects
of stress on participant’s methamphetamine use and salivary cortisol.
Cortisol is a hormone that is released into the bloodstream during stressful
situations and can be measured in saliva. Stress in life can have
effects on the brain and may affect how methamphetamine is used. Methamphetamine
is a drug that also produces chemical changes in the brain. These two
factors may change the level of cortisol in participants’ saliva.
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Perindopril-Methamphetamine Interaction Study
September 2003 – December 2006
Thomas Newton, Principal Investigator
The aim of this Phase I trial is to assess the safety of perindopril
treatment in a population of methamphetamine users so that an outpatient
trial can be conducted to assess whether perindopril will decrease craving
and relapse and thus help with cessation of methamphetamine use. This
is a double-blind inpatient study. Safety of methamphetamine administration
in perindopril-dosed subjects will be evaluated using primarily cardiovascular
assessments. Subjective effects of methamphetamine as well as ratings
of craving will also be assessed.
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Behavioral Therapy Development for Methamphetamine
Abuse
September 2004 – July 2007
James Peck, Principal Investigator
Aims of this project are to tailor an existing cognitive-behavioral group
intervention to HIV-seropositive methamphetamine-abusing men who have
sex with men (MSM), evaluate the feasibility of delivery in an HIV medical
care setting (the UCLA Center for Clinical AIDS Research and Education
[CARE] clinic), and obtain preliminary estimates of efficacy compared
to referral to a standard substance abuse treatment program.
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Double-Blind, Placebo Controlled Trial of Topiramate
for the Treatment of Methamphetamine Dependence
October 2005 – March 2007
Richard Rawson, Principal Investigator
This is a double-blind, multi-center, placebo-controlled, randomized,
parallel group design study of methamphetamine-dependent outpatients. It
is hypothesized that Topiramate treatment, compared to placebo, will
be associated with fewer days of MA use as measured by quantitative urine
analysis for MA.
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Prenatal Exposure to Methamphetamine
September 2001 – August 2006
Richard A. Rawson, Principal Investigator
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. We are conducting a longitudinal
study of prenatal MA exposure and child outcome in four states (Iowa,
Oklahoma, California, and Hawaii) in which MA use is prevalent. This
will be the first large-scale study of the developmental consequences
of prenatal MA exposure.
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Reducing Methamphetamine Use and HIV Sex-risk
Behaviors in Out-of-Treatment Men Who Have Sex with Men (MSM)
September 2006 – September 2008
Cathy Reback, Principal Investigator
This study assesses the feasibility and utility of an information technology
(IT) communication intervention for reducing sexual risk behaviors and
HIV acquisition and transmission among out-of-treatment, methamphetamine-using
MSM. Over the course of two weeks, methamphetamine-using MSM engage
in a variety of IT communication technologies (text messaging, e-mails,
instant messaging) to receive real-time HIV prevention messages, social
support, and referrals for healthier, prosocial choices regarding drug-
and sexual-risk behaviors.
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Voucher-based Incentive in a Prevention Setting
May 2004 – April 2009
Cathy Reback, Principal Investigator
In collaboration with a community-based agency, this randomized, control
trial assigns non-treatment seeking gay, bisexual, or men who have sex
with men (MSM) substance users to either a voucher-based incentive therapy
group or control group for 24 weeks. The voucher-based group earn
points for completing prosocial and healthy behaviors as well as attendance
at the community agency, whereas the control the control group only receives
voucher points for attendance.
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Methamphetamine Abuse Treatment is HIV Prevention
November 2004 – October 2007
Cathy Reback, Principal Investigator
This study evaluates an evidence-based, gay-specific cognitive behavioral
therapy (GCBT) intervention coupled with contingency management (CM)
to create an 8-week behavioral intervention for reducing HIV sexual and
drug risk behaviors among gay and bisexual methamphetamine users. The
intense GCBT+CM intervention is followed with an additional 8-week continuing
care intervention to support and maintain longer-term behavioral changes.
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