Substance-Related DisordersPhase 3NCT00032981
Motivational Enhancement to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse - 1
A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by Yale University at 6 sites in United States.
Trial 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. 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
- 561 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2001to Aug 2004
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
CT Renaissance, Inc.
Norwalk, Connecticut, 06852
Rehab After Work
Philadelphia, Pennsylvania, 19103
Northeast Treatment Center
Philadelphia, Pennsylvania, 19123
Haight Ashbury Free Clinics
San Francisco, California, 94117
LMG Programs, Inc.
Stamford, Connecticut, 06901
Tarzana Treatment Center
Tarzana, California, 91356
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance-Related Disorders
- Being tested
- Behavior Therapy
- Keywords
- substance use disorder
- 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.
Drug use
Retention
HIV risk behaviors
Psychosocial functioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2002 (estimated)
- Study startMay 2001
- Primary completionAug 2004
- Study completionAug 2004
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
- Allocation
- Randomised
- Enrolment
- 561 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Kathleen Carroll, Ph.D., Principal investigator, VA Connecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032981
- Sponsor's protocol ID
- NIDA-CTN-0004-1
- Status last verified
- Apr 2010
- First submitted
- 5 Apr 2002
- 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 Treatment (MET) to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse
- ClinicalTrials.gov ID
- NCT00032981
- Acronym / sponsor ID
- NIDA-CTN-0004-1
- Conditions
- Substance-Related Disorders
- Keywords
- substance use disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- May 2001
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 8 Apr 2002 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Are not sufficiently medically or psychiatrically stable to participate in outpatient treatment
- Are seeking detoxification only, methadone maintenance treatment or residential inpatient treatment
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
Drug use
Retention
HIV risk behaviors
Psychosocial functioning
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.
- Data ElementsLink provided by the sponsor.
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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
VA Connecticut Healthcare System
6 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 6 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 4 inclusion and 3 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 6 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?
Drug use. The study lists 4 primary outcomes in all. 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.