Intensive Motivational Interviewing for Methamphetamine Dependence
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|ClinicalTrials.gov Identifier: NCT01071356|
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Dependence||Behavioral: Intensive MI Behavioral: Single session MI||Phase 2|
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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.
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||217 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensive Motivational Interviewing for Methamphetamine Dependence|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Intensive MI
9 hours of Motivational Interviewing + outpatient substance abuse treatment
Behavioral: Intensive MI
Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education.
Active Comparator: Single session MI
1.5 hours of Motivational Interviewing + 8 hours of time equivalent nutrition classes +outpatient substance abuse treatment
Behavioral: Single session MI
Comparator arm that includes 1.5 hours of MI, 8 hours of nutrition classes and outpatient substance abuse treatment
- Methamphetamine Days of Abstinence : Proportion of Days Abstinent [ Time Frame: Weekly while in treatment (9 weeks) and 4 and 6 month follow up ]The proportion of days abstinent from methamphetamine was represented by univariate averages at each interview of the overall adjusted longitudinal treatment effects for each of the Standard (SMI) and Intensive (IMI) conditions. For example, a baseline average of 0.55 at baseline represents that study participants were abstinent, on average 55% of the days measured.
- Addiction Severity Index [ Time Frame: Baseline, 2-,4-, and 6-month follow up ]Addiction Severity Index - Lite (ASI) is a standardized, structured interview that assesses past 30 days problem severity in seven areas. These seven areas include medical, employment, drug, alcohol, legal, family/social and psychiatric status. Problem severity is rated on a scale of 0.0 - 1.0 with a higher score indicative of more problem severity. All scales have a range from 0 to 1.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071356
|United States, California|
|Alcohol Research Group|
|Emeryville, California, United States, 94608|
|Principal Investigator:||Douglas Polcin, Ed.D.||Alcohol Research Group / Public Health Institute|