Phase 2
N=217
Intensive Motivational Interviewing for Methamphetamine Dependence
Methamphetamine Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01071356 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Methamphetamine Days of Abstinence : Proportion of Days Abstinent — .56; .55; .74; .74 proportion of days abstinent — p=.47
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intensive MI (Behavioral); Single session MI (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Public Health Institute, California
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Methamphetamine Days of Abstinence : Proportion of Days Abstinent |
.56; .55; .74; .74; .75; .76 | .47 |
| SECONDARY Addiction Severity Index |
.27; .26; .22; .19; .19; .17 | .034 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 18 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.
Exclusion Criteria
- requires inpatient treatment for detoxification, medical or psychiatric treatment, and
- Serious psychiatric condition that would impair their ability to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT01071356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.