CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 217 enrolled
Drug / intervention
Intensive MI +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01071356
NCT01071356Phase 2Completed

Intensive Motivational Interviewing for Methamphetamine Dependence

Public Health Institute, California·interventional·Posted Feb 19, 2010·Updated May 24, 2018

In Brief

A Phase 2 clinical trial evaluating Intensive MI and Single session MI for Methamphetamine Dependence. Completed, enrolled 217 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2010
Enrollment StartFeb 1, 2009
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 16.4 years ago

Interventions

Intensive MIbehavioral

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.

Single session MIbehavioral

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