Clinical trial NCT01071356: Intensive Motivational Interviewing for Methamphetamine Dependence
Official title: Intensive Motivational Interviewing for Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine Dependence
Keywords: methamphetamine
motivational interviewing
Lead sponsor: Public Health Institute, California
Sponsor class: OTHER
First posted: 2010-02-19
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Stage 2 randomized clinical trial (RCT) to test the efficacy of a 9-session model of motivational interviewing (MI) for methamphetamine (MA) dependence. Stage 1 pilot testing indicated the intervention could be easily learned and implemented with fidelity. The tailored treatment approach draws upon our previous conceptual papers on MI as well as our experience with a variety of MI protocols, including two Clinical Trials Network (CTN) studies of MI. An innovative feature of the "Higher Dose Motivational Enhancement Therapy" manual is that it comprehensively addresses the issues of clients who have achieved sustained sobriety as well as those still using substances. Thus, it is designed to facilitate treatment entry and engagement as well as maintenance of the gains made in treatment. MA dependent clients (N=220) were recruited from New Leaf outpatient treatment in Lafayette, California. Study participants were randomly assigned to 1) a single session of Motivational Interviewing (MI) plus 8 hours of health/nutrition education, or 2) the intensive 9-session MI intervention. In addition to the study interventions, both groups received standard outpatient treatment services at New Leaf. Study participants were assessed weekly during the first 9 weeks of treatment for MA use. More extensive assessments were conducted at treatment entry and 2-, 4-and 6-month follow-ups. Two therapists were "crossed" to treat clients in both conditions. Primary outcome measures included Timeline Follow Back (TLFB) for MA use, MA urinalysis results, and retention in treatment. Secondary outcomes include Addiction Severity Index scales and the TLFB for alcohol and other drugs. A mediation model will build upon MI research proposed by Moyers (2005) and our construct of "supportive confrontation" by testing whether feedback enhanced with warnings about the potential harm of MA use facilitates the therapeutic alliance, and whether this in turn facilitates better outcome. Clients with MA dependence are good candidates for a more intensive dose of MI because of their severe medical and psychosocial problems.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Methamphetamine Days of Abstinence : Proportion of Days Abstinent
timeFrame: Weekly while in treatment (9 weeks) and 4 and 6 month follow up
Secondary outcomes:
measure: Addiction Severity Index
timeFrame: Baseline, 2-,4-, and 6-month follow up
Other outcomes:
Locations:
city: Emeryville
country: United States
facility: Alcohol Research Group
state: California
Study officials:
affiliation: Alcohol Research Group / Public Health Institute
name: Douglas Polcin, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burke BL, Arkowitz H, Menchola M. The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials. J Consult Clin Psychol. 2003 Oct;71(5):843-61. doi: 10.1037/0022-006X.71.5.843.
citation: Carroll KM, Ball SA, Nich C, Martino S, Frankforter TL, Farentinos C, Kunkel LE, Mikulich-Gilbertson SK, Morgenstern J, Obert JL, Polcin D, Snead N, Woody GE; National Institute on Drug Abuse Clinical Trials Network. Motivational interviewing to improve treatment engagement and outcome in individuals seeking treatment for substance abuse: a multisite effectiveness study. Drug Alcohol Depend. 2006 Feb 28;81(3):301-12. doi: 10.1016/j.drugalcdep.2005.08.002. Epub 2005 Sep 28.
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citation: Martino S, Ball SA, Gallon SL, et al. Motivational Interviewing Assessment: Supervisory tools for enhancing proficiency Salem, OR: Northwest Frontier Addiction Technology Transfer Center, Oregon Health and Science University. 2006 [Accessed: 2013-02-05. Archived by WebCite® at http://www.webcitation.org/6EDD4BNKM];
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