Substance AbusePhase 1/2NCT00685074
Computer-based Brief Intervention for Perinatal Substance Abuse
A Phase 1/2 study testing Computer-based Motivational Interviewing in people with Substance Abuse, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of the study is to see if a brief computer program can help new mothers cut down or quit tobacco, alcohol, or drug use. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Computer-based Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Mar 2011
- Phase
- Phase 1/2
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hospitalized women in immediate post-partum period
- Self report of illicit drug use, problem alcohol use, or tobacco use in month prior to pregnancy
Who cannot join
- Frank psychosis or other cognitive impairment
- Inability to communicate in English
- No sleep since giving birth
- Recent receipt of narcotic pain medication
- Grieving over medically compromised infant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse
The purpose of the study is to see if a brief computer program can help new mothers cut down or quit tobacco, alcohol, or drug use.
Read the detailed description
The purpose of this Stage I/II intervention study (that is, Stage II for drug use and Stage I for alcohol use and smoking) is to test the efficacy of a brief, computerized motivational intervention for substance abuse among post-partum women. The study will randomly assign 350 post-partum women to either intervention or control conditions, with intervention itself taking approximately 30 minutes in the period before the participant leaves the hospital. Inclusion criteria will include post-partum status, age between 18 and 45, ability to understand spoken English, and meeting criteria for one of the three substance use groups: any illicit drug use in month prior to pregnancy, meeting T-ACE criteria for problem alcohol use, or smoking in past month. Exclusion criteria will include receipt of narcotic pain medication in the past 3 hours, no sleep since giving birth, and inability to provide informed consent (e.g., due to psychosis or other clear cognitive impairment).
Lab-based follow-up will occur at 3- and 6-months postpartum. The primary outcomes will be participant report of frequency of substance use and toxicological analyses of substance use (urinalysis and expired breath CO at 3 and 6 month follow-up, hair analysis at 6-month follow-up). Secondary outcome measures include HIV risk behaviors, receipt of treatment services, motivation to change, self-efficacy, mental health functioning, violence exposure, and consequences related to substance use.
- Conditions
- Substance Abuse
- Being tested
- Computer-based Motivational Interviewing, Time control
- Keywords
- Motivational Interview, Computer based intervention, Substance abuse, post-partum
- 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.
Computer-based Motivational InterviewingBehavioural
Also called Motivation Enhancement System
The software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order.
Time controlBehavioural
A series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control.
| Study group | Role | What they receive |
|---|---|---|
| Brief computer-delivered intervention for drug use | Experimental | A single interactive computer intervention based primarily on Motivational Interviewing principles. Receives: Behavioral: Computer-based Motivational Interviewing |
| Time control for drug use | Placebo comparator | An series of innocuous and therapeutically inactive computer segments. Receives: Behavioral: Time control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use at 3 months
Measured: 3 months
Drug use at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startSep 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steven J. Ondersma, Wayne State University
- Investigators
- Steven J. Ondersma, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685074
- Sponsor's protocol ID
- MES-III
- Other IDs
- 5R01DA021329-04, DA021329-01
- Status last verified
- Oct 2011
- First submitted
- 23 May 2008
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse
- ClinicalTrials.gov ID
- NCT00685074
- Acronym / sponsor ID
- MES-III
- Conditions
- Substance Abuse
- Keywords
- Motivational Interview, Computer based intervention, Substance abuse, post-partum
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 May 2008 (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 the study is to see if a brief computer program can help new mothers cut down or quit tobacco, alcohol, or drug use.
Detailed description
The purpose of this Stage I/II intervention study (that is, Stage II for drug use and Stage I for alcohol use and smoking) is to test the efficacy of a brief, computerized motivational intervention for substance abuse among post-partum women. The study will randomly assign 350 post-partum women to either intervention or control conditions, with intervention itself taking approximately 30 minutes in the period before the participant leaves the hospital. Inclusion criteria will include post-partum status, age between 18 and 45, ability to understand spoken English, and meeting criteria for one of the three substance use groups: any illicit drug use in month prior to pregnancy, meeting T-ACE criteria for problem alcohol use, or smoking in past month. Exclusion criteria will include receipt of narcotic pain medication in the past 3 hours, no sleep since giving birth, and inability to provide informed consent (e.g., due to psychosis or other clear cognitive impairment).
Lab-based follow-up will occur at 3- and 6-months postpartum. The primary outcomes will be participant report of frequency of substance use and toxicological analyses of substance use (urinalysis and expired breath CO at 3 and 6 month follow-up, hair analysis at 6-month follow-up). Secondary outcome measures include HIV risk behaviors, receipt of treatment services, motivation to change, self-efficacy, mental health functioning, violence exposure, and consequences related to substance use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief computer-delivered intervention for drug use | Experimental | Behavioral: Computer-based Motivational InterviewingA single interactive computer intervention based primarily on Motivational Interviewing principles. |
| Time control for drug use | Placebo comparator | Behavioral: Time controlAn series of innocuous and therapeutically inactive computer segments. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hospitalized women in immediate post-partum period
- Self report of illicit drug use, problem alcohol use, or tobacco use in month prior to pregnancy
Key exclusion criteria (5 listed)
- Frank psychosis or other cognitive impairment
- Inability to communicate in English
- No sleep since giving birth
- Recent receipt of narcotic pain medication
- Grieving over medically compromised infant
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 |
|---|---|---|
| Computer-based Motivational InterviewingAlso: Motivation Enhancement SystemThe software includes three intervention components - pros and cons, feedback, and optional goal-setting in a fixed order. | Behavioural | Brief computer-delivered intervention for drug use |
| Time controlA series of therapeutically inactive videos and questions to (a) maintain RA blind, and (b) serve as a time control. | Behavioural | Time control for drug use |
Primary outcome
Drug use at 3 months
Time frame: 3 months
Drug use at 6 months
Time frame: 6 months
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 14 Oct 2011.
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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.
Steven J. Ondersma, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Computer-based Motivational Interviewing in people with Substance Abuse, run by Wayne State University at 1 site 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 2 inclusion and 5 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 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 at 3 months (time frame: 3 months). 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?
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 14 Oct 2011; AzTrials last refreshed its copy on 2 Nov 2026.