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Intensive Motivational Interviewing for Methamphetamine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcoholresearchgroup, Public Health Institute, California
ClinicalTrials.gov Identifier:
NCT01071356
First received: February 17, 2010
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

A Stage 2 randomized clinical trial (RCT) is proposed to test the efficacy of a promising 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 sample of 30 MA dependent individuals over 9 weeks showed large reductions in MA use, good retention and consistent attendance. 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. We posit that a more intensive MI model is necessary to address MA dependent individuals because they frequently present more serious problems than individuals with other substance dependencies and are more prone to lose the gains they make in treatment. MA dependent clients (N=220) will be recruited from New Leaf outpatient treatment in Lafayette, California. This site has a long history of conducting research, including participation in a multi-site study assessing treatment outcome of MA dependence. Study participants will be 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 will receive standard outpatient treatment services at New Leaf. Study participants will be assessed weekly during the first 9 weeks of treatment for MA use. More extensive assessments will be conducted at treatment entry and 2-, 4-and 6-month follow-ups. Two therapists will be "crossed" and treat clients in both conditions. Primary outcome measures will be the Timeline Follow Back (TLFB) for MA use, MA urinalysis results, and retention in treatment. Secondary outcomes will include Addiction Severity Index scales and the TLFB for alcohol and other drugs. Exploratory analyses will examine HIV risk behaviors, motivation, and service utilization. A mediation model will build upon MI research by Moyers et al. (2005) and our construct of "supportive confrontation" (Polcin, et al., 2006) 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. The significance of the study is highlighted by a recent meta-analysis finding higher doses of MI were associated with better outcomes (Burke et al., 2003). Conversely, several recent studies of standard single session MI with drug dependent clients questioned its effectiveness, while other studies found improvement in retention but not substance use. Clients with MA dependence are good candidates for a more intensive dose of MI because of their severe medical and psychosocial problems. Thus, it is time to test this promising, 9-session MI manual as a useful extension of standard MI for clients with MA dependence.


Condition Intervention Phase
Methamphetamine Dependence
Behavioral: Intensive Motivational Interviewing
Behavioral: Single session of Motivational Interviewing
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intensive Motivational Interviewing for Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by Public Health Institute, California:

Primary Outcome Measures:
  • Methamphetamine positive urine screens [ Time Frame: Weekly while in treatment (9 weeks) and 4 and 6 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Addiction Severity Index [ Time Frame: Baseline, 2-,4-, and 6-month follow up ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: February 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 9 sessions of Motivational Interviewing
Respondents received 9 1-hour sessions of Motivational Interviewing therapy concurrent with outpatient drug treatment.
Behavioral: Intensive Motivational Interviewing
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: 1 session of Motivational Interviewing + 8 sessions nutrition
Respondents received one 1.5-hour session of Motivational Interviewing therapy at the outset of entering outpatient drug treatment.
Behavioral: Single session of Motivational Interviewing

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Alcoholresearchgroup, Douglas L Polcin, Ed.D, Public Health Institute, California
ClinicalTrials.gov Identifier: NCT01071356     History of Changes
Other Study ID Numbers: 1R01DA024714
Study First Received: February 17, 2010
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Methamphetamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Autonomic Agents
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014