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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
Sponsor:
Information provided by (Responsible Party):
Alcoholresearchgroup, Public Health Institute, California

Study Description
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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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Behavioral: Intensive MI Behavioral: Single session MI Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
United States, California
Alcohol Research Group
Emeryville, California, United States, 94608
Sponsors and Collaborators
Public Health Institute, California
Investigators
Principal Investigator: Douglas Polcin, Ed.D. Alcohol Research Group / Public Health Institute
More Information
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Additional Information:
website  This link exits the ClinicalTrials.gov site

Publications:
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];
Polcin DL. Reexamining confrontation and Motivational Interviewing. Addict Disord Their Treat 2006;5:201-9.
Polcin DL, Brown M, Galloway GP. Intensive Motivational Enhancement Therapy Manual. Berkeley, CA: Alcohol Research Group; 2005.

Responsible Party: Alcoholresearchgroup, Douglas L Polcin, Ed.D, Public Health Institute, California
ClinicalTrials.gov Identifier: NCT01071356     History of Changes
Other Study ID Numbers: 1R01DA024714 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2010    Key Record Dates
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

Keywords provided by Alcoholresearchgroup, Public Health Institute, California:
methamphetamine
motivational interviewing

Additional relevant MeSH terms:
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors