Substance-Related DisordersPhase 3NCT00078143
Motivational Enhancement Therapy to Improve Treatment Utilization in Pregnant Substance Users - 1
A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by University of Cincinnati at 6 sites in United States.
Trial summary
The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard drug abuse treatment among pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2003to Apr 2006
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnancy <30 weeks
- Have not attended drug treatment in past 28 days
- Not needing residential treatment (except detox)
- Not at risk for suicide/homicide
- Have no pending legal charges (except drug treatment)
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Milagro Clinic
Albuquerque, New Mexico, 87106
Milagro
Albuquerque, New Mexico, 87106
Eleonore Hutzel Recovery Center
Detroit, Michigan, 48201
Midtown Community Mental Health Center
Indianapolis, Indiana, 46202
Jefferson Alcohol & Drug Abuse Center
Louisville, Kentucky, 40202
Coastal Horizons Center, Inc.
Wilmington, North Carolina, 28412
About this study
Official title: Motivational Enhancement Therapy (MET) to Improve Treatment Utilization in Pregnant Substance Users
The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard drug abuse treatment among pregnant women.
- 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 Utilization
Substance Abuse
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 startOct 2003
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Investigators
- Theresa Winhusen, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078143
- Sponsor's protocol ID
- NIDA-CTN-0013-1
- Status last verified
- Oct 2016
- First submitted
- 19 Feb 2004
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Osterman R, Lewis D, Winhusen T. Efficacy of motivational enhancement therapy to decrease alcohol and illicit-drug use in pregnant substance users reporting baseline alcohol use. J Subst Abuse Treat. 2017 Jun;77:150-155. doi: 10.1016/j.jsat.2017.02.003. Epub 2017 Feb 21.
PubMed 28254158Winhusen T, Lewis D. Cigarette smoking in pregnant substance users: Association with substance use and desire to quit. J Addict Dis. 2017 Jan-Mar;36(1):88-91. doi: 10.1080/10550887.2016.1254992. Epub 2016 Nov 1.
PubMed 27802114
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 Therapy (MET) to Improve Treatment Utilization in Pregnant Substance Users
- ClinicalTrials.gov ID
- NCT00078143
- Acronym / sponsor ID
- NIDA-CTN-0013-1
- Conditions
- Substance-Related Disorders
- Keywords
- behavioral intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (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 Motivational Enhancement Therapy (MET) with standard drug abuse treatment among pregnant women.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnancy <30 weeks
- Have not attended drug treatment in past 28 days
- Not needing residential treatment (except detox)
- Not at risk for suicide/homicide
- Have no pending legal charges (except drug treatment)
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 Utilization
Substance Abuse
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.
- Derived from this study: PubMed 28254158Osterman R, Lewis D, Winhusen T. Efficacy of motivational enhancement therapy to decrease alcohol and illicit-drug use in pregnant substance users reporting baseline alcohol use. J Subst Abuse Treat. 2017 Jun;77:150-155. doi: 10.1016/j.jsat.2017.02.003. Epub 2017 Feb 21.
- Derived from this study: PubMed 27802114Winhusen T, Lewis D. Cigarette smoking in pregnant substance users: Association with substance use and desire to quit. J Addict Dis. 2017 Jan-Mar;36(1):88-91. doi: 10.1080/10550887.2016.1254992. Epub 2016 Nov 1.
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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.
Theresa Winhusen, Ph.D. principal investigator
University of Cincinnati
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 University of Cincinnati 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 5 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 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?
Treatment Utilization. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00078143, which also lists 2 linked publications.
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.