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| Tracking Information | |||||
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| First Received Date ICMJE | April 5, 2002 | ||||
| Last Updated Date | June 18, 2009 | ||||
| Start Date ICMJE | May 2001 | ||||
| Primary Completion Date | August 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00032981 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Motivational Enhancement to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse - 1 | ||||
| Official Title ICMJE | Motivational Enhancement Treatment (MET) to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse | ||||
| Brief Summary | The purpose of this study is to evaluate the therapeutic usefulness of incorporating Motivational Enhancement Treatment into the standard drug abuse treatment entry process of Community Treatment Programs on improving treatment engagement, retention, and outcome. |
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| Detailed Description | Participants seeking treatment at the participating CTPs will be randomly assigned to either "standard" or "MET/MI" treatment, with a 1- and 3-month follow-up. Primary outcome measures will include (1) treatment retention (e.g., number of sessions/weeks completed, the rate of patients completing 3 or more subsequent sessions, and (2) substance use (e.g., urinalyses, days of opioid, cocaine, marijuana, alcohol use, rates of abstinence). Secondary outcomes will include motivation, psychosocial functioning, HIV risk behaviors, treatment utilization, and patient satisfaction. Process assessments will include measures of the working alliance as well as therapist adherence/competence ratings which will evaluate how effectively MET/MI was implemented. Participating CTPs will implement one of two independent protocols, depending on which is the best suited or feasible for the intake procedures at their clinic. Thus, following an invitation to participate, explanation of the study, and provision of informed consent, patients would complete a brief assessment battery followed by either: 1) Random assignment to 3 individual sessions of standard treatment (treatment as usual) at the program versus 3 individual sessions of MET. or 2) Random assignment to 1 individual standard assessment/evaluation session. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized | ||||
| Condition ICMJE | Substance-Related Disorders | ||||
| Intervention ICMJE | Behavioral: Behavior Therapy | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 561 | ||||
| Completion Date | August 2004 | ||||
| Primary Completion Date | August 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Individuals will be eligible for the protocol who:
Exclusion Criteria: Individuals will be excluded who:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00032981 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIDA-CTN-0004-1 | ||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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