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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 is a Phase 2 study that has completed, run by Public Health Institute, California. The registered enrollment target is 217 participants.
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
Interventions
- BEHAVIORAL Intensive MI
- BEHAVIORAL Single session MI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01071356
The ClinicalTrials.gov registry entry for NCT01071356 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Public Health Institute, California, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intensive MI is the first listed.
NCT01071356 reports 0 study locations.
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.
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