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NCT01071356 · ClinicalTrials.gov registry record · Phase 2

Intensive Motivational Interviewing for Methamphetamine Dependence

A Phase 2 study, sponsored by Public Health Institute, California.

Completed
Registry status
Phase 2
Development phase
217
Enrollment target

NCT01071356: Completed Phase 2 study, sponsored by Public Health Institute, California.

NCT01071356 is a Phase 2 study that has completed, run by Public Health Institute, California. The registered enrollment target is 217 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01071356, a Phase 2 study, has completed, sponsored by Public Health Institute, California.

COMPLETED
Registry status
Phase 2
Development phase
217 participants
Enrollment target

Study 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 depe

Primary Outcome

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.

Interventions

  • BEHAVIORAL Intensive MI
  • BEHAVIORAL Single session MI

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2009-02
Est. Completion 2012-10
Phase Phase 2

What the finished NCT01071356 record still lists

NCT01071356 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% higher).

The record links to 0 conditions, and to 2 interventions - of which Intensive MI is the first listed.

NCT01071356 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01071356 about?

NCT01071356 is a clinical study titled "Intensive Motivational Interviewing for Methamphetamine Dependence". 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 upo...

What is the current status of trial NCT01071356?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2009-02. Estimated completion is 2012-10.

What interventions are being tested in trial NCT01071356?

The interventions under investigation include: Intensive MI (BEHAVIORAL), Single session MI (BEHAVIORAL).

Who is sponsoring clinical trial NCT01071356?

This trial is sponsored by Public Health Institute, California, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01071356's enrollment target sits among peer trials

217 286th of 2000 higher than 1,715 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01071356, the US trial registry maintained by the National Library of Medicine. NCT01071356 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.