Substance-Related DisordersPhase 3NCT00078169
Motivational Enhancement for Spanish Speaking Individuals - 1
A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by Yale University at 7 sites in United States.
Trial summary
The purpose of this study is to compare a three-session Spanish version of Motivational Enhancement Therapy (MET) to standard treatment to see how well MET engages and retains Spanish-speaking clients in outpatient substance abuse treatment. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 463 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2003to Oct 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects included unless medical/psychiatrically unstable
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Counseling & Psychotherapy Institute
Albuquerque, New Mexico, 87194
Island Grove RTC
Greeley, Colorado, 80631
Narco Freedom (Bridge Plaza)
Long Island City, New York, 11101
Miami Behavioral Health
Miami, Florida, 33161
Changepoint - Cedar Hills Blvd
Portland, Oregon, 97292
Changepoint, Inc.
Portland, Oregon, 97402
The Life Link
Santa Fe, New Mexico, 87505
About this study
Official title: Motivational Enhancement for Spanish Speaking Individuals
The purpose of this study is to compare a three-session Spanish version of Motivational Enhancement Therapy (MET) to standard treatment to see how well MET engages and retains Spanish-speaking clients in outpatient substance abuse treatment.
- Conditions
- Substance-Related Disorders
- Being tested
- Behavior Therapy
- Keywords
- behavioral intervention
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment retention, drug and alcohol abstinence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2004 (estimated)
- Study startNov 2003
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 463 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Investigators
- Kathleen Carroll, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078169
- Sponsor's protocol ID
- NIDA-CTN-0021-1
- Status last verified
- Oct 2016
- First submitted
- 19 Feb 2004
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Enhancement for Spanish Speaking Individuals
- ClinicalTrials.gov ID
- NCT00078169
- Acronym / sponsor ID
- NIDA-CTN-0021-1
- Conditions
- Substance-Related Disorders
- Keywords
- behavioral intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- Nov 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 23 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare a three-session Spanish version of Motivational Enhancement Therapy (MET) to standard treatment to see how well MET engages and retains Spanish-speaking clients in outpatient substance abuse treatment.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects included unless medical/psychiatrically unstable
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior Therapy | Behavioural | – |
Primary outcome
Treatment retention, drug and alcohol abstinence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Carroll, Ph.D. principal investigator
Yale University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by Yale University at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment retention, drug and alcohol abstinence. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.