- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00032981
Motivational Enhancement to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse - 1
January 11, 2017 updated by: Yale University
Motivational Enhancement Treatment (MET) to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
561
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94117
- Haight Ashbury Free Clinics
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Tarzana, California, United States, 91356
- Tarzana Treatment Center
-
-
Connecticut
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Norwalk, Connecticut, United States, 06852
- CT Renaissance, Inc.
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Stamford, Connecticut, United States, 06901
- LMG Programs, Inc.
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19103
- Rehab After Work
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Philadelphia, Pennsylvania, United States, 19123
- NorthEast Treatment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Individuals will be eligible for the protocol who:
- Are seeking outpatient treatment for any substance use disorder
- Are willing to participate in the protocol (e.g., to be randomized to treatment, be contacted for follow-up assessment, to have their sessions audiotaped)
- Are able to understand and provide written informed consent
Exclusion Criteria:
Individuals will be excluded who:
- Are not sufficiently medically or psychiatrically stable to participate in outpatient treatment
- Are seeking detoxification only, methadone maintenance treatment or residential inpatient treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Drug use
|
Retention
|
Psychosocial functioning
|
HIV risk behaviors
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kathleen Carroll, Ph.D., VA Connecticut Healthcare System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2001
Primary Completion (Actual)
August 1, 2004
Study Completion (Actual)
August 1, 2004
Study Registration Dates
First Submitted
April 5, 2002
First Submitted That Met QC Criteria
April 5, 2002
First Posted (Estimate)
April 8, 2002
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDA-CTN-0004-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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