Intensive Motivational Interviewing for Methamphetamine Dependence

NCT01071356 | Completed Phase 2 Results

• 1 other identifier: 1R01DA024714
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 1

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.

Conditions

Methamphetamine Dependence

Keywords

methamphetamine; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• Methamphetamine Days of Abstinence : Proportion of Days Abstinent

  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.

  Weekly while in treatment (9 weeks) and 4 and 6 month follow up

Secondary Outcomes (1)

• Addiction Severity Index

  Baseline, 2-,4-, and 6-month follow up

Study Arms (2)

Intensive MI

EXPERIMENTAL

9 hours of Motivational Interviewing + outpatient substance abuse treatment

Behavioral: Intensive MI

Single session MI

ACTIVE COMPARATOR

1.5 hours of Motivational Interviewing + 8 hours of time equivalent nutrition classes +outpatient substance abuse treatment

Behavioral: Single session MI

Interventions

Intensive MI BEHAVIORAL

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.

Intensive MI

Single session MI BEHAVIORAL

Comparator arm that includes 1.5 hours of MI, 8 hours of nutrition classes and outpatient substance abuse treatment

Single session MI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old,
• Meets DSM IV criteria for MA dependence during the past year as assesses by the DSM-IV Checklist,
• able to speak and read English,
• capable of giving informed consent, and
• likely to be in the area the next 6 months.

You may not qualify if:

• requires inpatient treatment for detoxification, medical or psychiatric treatment, and
• Serious psychiatric condition that would impair their ability to provide informed consent.

Sponsors & Collaborators

• Public Health Institute, California: lead

Study Sites (1)

Alcohol Research Group

Emeryville, California, 94608, United States

Location

Related Publications (15)

• 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.

  PMID: 14516234 BACKGROUND

• 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.

  PMID: 16169159 BACKGROUND

• Rawson RA, Marinelli-Casey P, Anglin MD, Dickow A, Frazier Y, Gallagher C, Galloway GP, Herrell J, Huber A, McCann MJ, Obert J, Pennell S, Reiber C, Vandersloot D, Zweben J; Methamphetamine Treatment Project Corporate Authors. A multi-site comparison of psychosocial approaches for the treatment of methamphetamine dependence. Addiction. 2004 Jun;99(6):708-17. doi: 10.1111/j.1360-0443.2004.00707.x.

  PMID: 15139869 BACKGROUND

• Polcin DL, Galloway GP, Palmer J, Mains W. The case for high-dose motivational enhancement therapy. Subst Use Misuse. 2004 Jan;39(2):331-43. doi: 10.1081/ja-120028494.

  PMID: 15061564 BACKGROUND

• Galloway GP, Polcin D, Kielstein A, Brown M, Mendelson J. A nine session manual of motivational enhancement therapy for methamphetamine dependence: adherence and efficacy. J Psychoactive Drugs. 2007 Nov;Suppl 4:393-400. doi: 10.1080/02791072.2007.10399900.

  PMID: 18286727 BACKGROUND

• 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];

  BACKGROUND

• Moyers TB, Miller WR, Hendrickson SML. How does motivational interviewing work? Therapist interpersonal skill predicts client involvement within motivational interviewing sessions. J Consult Clin Psychol. 2005 Aug;73(4):590-598. doi: 10.1037/0022-006X.73.4.590.

  PMID: 16173846 BACKGROUND

• Polcin DL. Reexamining confrontation and Motivational Interviewing. Addict Disord Their Treat 2006;5:201-9.

  BACKGROUND

• Polcin DL, Brown M, Galloway GP. Intensive Motivational Enhancement Therapy Manual. Berkeley, CA: Alcohol Research Group; 2005.

  BACKGROUND

• Rawson RA, Condon TP. Why do we need an Addiction supplement focused on methamphetamine? Addiction. 2007 Apr;102 Suppl 1:1-4. doi: 10.1111/j.1360-0443.2006.01781.x.

  PMID: 17493048 BACKGROUND

• Anglin MD, Urada D, Brecht ML, Hawken A, Rawson R, Longshore D. Criminal justice itreatment admissions for methamphetamine use in California: a focus on Proposition 36. J Psychoactive Drugs. 2007 Nov;Suppl 4:367-81. doi: 10.1080/02791072.2007.10399898.

  PMID: 18284103 BACKGROUND

• Vocci FJ, Appel NM. Approaches to the development of medications for the treatment of methamphetamine dependence. Addiction. 2007 Apr;102 Suppl 1:96-106. doi: 10.1111/j.1360-0443.2007.01772.x.

  PMID: 17493058 BACKGROUND

• Harris MH. Meth--it's everybody's problem. S D J Med. 2003 Sep;56(9):375-6. No abstract available.

  PMID: 14524136 BACKGROUND

• Galloway GP, Marinelli-Casey P, Stalcup J, Lord R, Christian D, Cohen J, Reiber C, Vandersloot D. Treatment-as-usual in the methamphetamine treatment project. J Psychoactive Drugs. 2000 Apr-Jun;32(2):165-75. doi: 10.1080/02791072.2000.10400225.

  PMID: 10908004 BACKGROUND

• Miller WR, Benefield RG, Tonigan JS. Enhancing motivation for change in problem drinking: a controlled comparison of two therapist styles. J Consult Clin Psychol. 1993 Jun;61(3):455-61. doi: 10.1037//0022-006x.61.3.455.

  PMID: 8326047 BACKGROUND

Related Links

• website

Results Point of Contact

• Title: Dr. Douglas Polcin
• Organization: Public Health Institute: Alcohol Research Group

dpolcin@arg.org

510-597-3440

Study Officials

• Douglas Polcin, Ed.D.

  Alcohol Research Group / Public Health Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Douglas L Polcin, Ed.D

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 19, 2010
• Study Start: February 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 24, 2018
• Results First Posted: May 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)