Intensive Motivational Interviewing for Methamphetamine Dependence

This proposal responds to PA-07-111, "Behavioral & Integrative Treatment Development Program"
issued by the National Institute on Drug Abuse. Based on promising pilot data, we propose to
test the efficacy of a 9-session Motivational Interviewing (MI) manual for treating
methamphetamine (MA) dependence (Galloway, Polcin, Kielstein, Brown & Mendelson, 2007;
Polcin, Galloway, Palmer & Mains, 2004; Polcin, Brown & Galloway, 2005). (See Appendix A for
a copy of the Intensive and Standard Manuals and Appendix B for our papers describing the
rationale for its structure). The study builds upon a progression in our work from initial
conceptualization of a more intensive model of MI (Polcin, et al., 2004), to development of
the "Higher Dose Motivational Enhancement Therapy Manual" (Polcin, et al., 2005), to
presentation of very promising stage 1 pilot data (Galloway, et al, 2007). The proposed study
represents a logical next step in this research program.

In a meta-analysis of MI studies, Burke, Arkowitz & Menchola (2003) found that higher doses
of MI were associated with better outcome. Based on this finding, they called for new studies
to compare the effectiveness of standard low dose and more intensive MI. This proposal
responds to that call. To date, no direct comparisons between high and low intensity MI have
been published, and we are not aware of any intensive manuals other than the one presented
here.

Our proposal addresses the aims of the NIDA Program Announcement (PA-07-111) well because the
announcement calls for innovations and refinements of behavioral therapies for understudied
populations. Clients with MA dependence are specifically identified as an understudied
population in need of behavioral therapy trials. MA use is rampant in the Western U.S. and is
growing in other parts of the country as well as oversees (Anglin et al., 2007; Rawson &
Condon, 2007). Studies have shown MA dependent individuals frequently present serious medical
and psychiatric conditions that complicate treatment efforts (Rawson, et al., 2000, 2004).
Based on excellent retention of clients during our pilot testing (see Pilot Study outcomes in
the Preliminary Studies section), we hypothesize intensive MI will be particularly useful in
improving high treatment dropout rates and low engagement among MA dependent clients.
Behavioral interventions are particularly needed because there are currently no evidence
based pharmacological protocols for treating MA dependence (Vocci & Appel, 2007).

In this proposal, our "standard" MI condition is a single session of manual based MI (Martino
et al., 2006) plus eight hours of health/nutrition education using a structured educational
format (Harris, 2003, 2006). A copy of both MI interventions can be found in Appendix A and a
draft version of the nutrition/health intervention can be found in Appendix D. Our
"intensive" MI condition refers to our 9-session manual intervention. As detailed in the
Preliminary Studies Section, the development of our manual, methods for stage 1 pilot
testing, and procedures for training therapists have followed recommendations made by
Rounsaville, Carroll, and Onken (2001) and Carroll et al. (2006). As a stage 2 behavioral
trial, the study includes an assessment of dose-response relationships and has a high
likelihood of illuminating potential mechanisms of action within a single data collection
site. Positive findings here will lead to stage 3 applications examining the effectiveness of
the intervention in community-based settings using multi-site designs that would allow
broader generalization.

MA dependent participants will be recruited from the New Leaf outpatient treatment program in
Lafayette, California. This data collection site has a history of successfully recruiting MA
dependent clients into research protocols (e.g., Galloway, et. al., 2000; Rawson et. al.,
2004). In addition to receiving one of the MI interventions, all participants will receive
standard outpatient treatment offered at New Leaf.

The specific aims and hypotheses are detailed below. In addition to comparing treatment
conditions on outcome measures, in an overlaid naturalistic design we will build upon MI
research examining mediators of outcome conducted by Moyers, Miller & Hendickson (2005). We
propose to assess the impact of a modified definition of feedback on the therapeutic alliance
and in turn on MA use. Our definition of feedback includes providing objective information
and personalized feedback to clients, but we add to this our construct of supportive
confrontation (Polcin, 2006a; Polcin, Galloway & Greenfield, 2006; Polcin, Galloway, Bostrom
& Greenfield, 2007; Polcin & Greenfield, 2006). This concept entails providing warnings to
the client about potential harm that might result if action is not taken to address problem
areas. Supportive confrontation is an integral part of feedback in our MI interventions and
we provide data in our Preliminary Studies (see the Measuring Confrontation during Recovery
subheading) indicating that this type of confrontation is experienced as supportive, accurate
and helpful (e.g. Polcin et al., 2006). We also suggest that our findings are consistent with
the work of Moyers, et al. (2005), who found some confrontational interventions were
associated with an enhanced therapeutic alliance when they were delivered from therapists
with a high degree of skill. To avoid destructive interactions that Miller, Benefield and
Tonigan (1993) found to be counterproductive (e.g., argumentation) therapists will "roll with
resistance" when encountering clients who react defensively or reject confrontational
statements.

Aim 1. To compare MA use and retention in treatment among clients receiving intensive and
standard MI.

Hypothesis 1.1: The intensive MI condition will demonstrate longer retention in treatment,
fewer days of MA use, and fewer positive urine tests than the standard MI condition during
the first 9 weeks of treatment.

Hypothesis 1.2: The intensive MI condition will demonstrate fewer days of MA use and fewer
positive urine tests than the standard MI condition at the 2-, 4-, and 6-month follow-ups.

Aim 2. To compare Addiction Severity Index (ASI) scales among clients receiving intensive and
standard MI.

Hypothesis 2.1: ASI scores for clients in the intensive condition will be significantly lower
than scores in the standard condition at 2-, 4-, and 6-month follow-ups.

Aim 3. To assess whether feedback enhanced with supportive confrontation directly impacts
outcome and impacts outcome indirectly through a stronger therapeutic alliance.

Hypothesis 3.1: Higher Frequency/Extensiveness and Skill Level of Feedback enhanced with
supportive confrontation will decrease MA use.

Hypothesis 3.2: Higher Frequency/Extensiveness and Skill Level of Feedback enhanced with
supportive confrontation will enhance the therapeutic alliance, which will in turn impact MA
use.

Exploratory Analyses

1. We will make repeated measures comparisons between the two treatment conditions for use
of alcohol and other drugs in addition to MA. These will include self-report measures as
well as urine screens and breathalyzer results.

2. We will compare intensive and standard MI on services utilization, which assesses use of
additional formal treatment and informal recovery services such as self-help groups.

3. We will compare longitudinal measures of motivation between the two conditions and
assess whether higher motivation is associated with better outcome. 4) We will compare
HIV risk behaviors among clients receiving intensive and standard MI.

Inclusion Criteria:

1. 18 years old,

2. Meets DSM IV criteria for MA dependence during the past year as assesses by the DSM-IV
Checklist,

3. able to speak and read English,

4. capable of giving informed consent, and

5. likely to be in the area the next 6 months.

Exclusion Criteria:

1. requires inpatient treatment for detoxification, medical or psychiatric treatment, and

2. Serious psychiatric condition that would impair their ability to provide informed
consent.