Marijuana UseNCT02191605
Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
A study testing eSBIRT and Tailored texting in people with Marijuana Use and Pregnancy, run by Wayne State University at 1 site in United States.
Trial summary
Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal exposure to marijuana can have lasting negative effects. However, current answers to this problem are failing to reach most women who use marijuana while pregnant. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Marijuana Use, Pregnancy
- What is being tested?
- eSBIRT and Tailored texting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2015to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 40 years of age
- 20 weeks or less gestation
- intention to carry pregnancy to term
- self-reported marijuana use in month before pregnancy
- own a cell phone and willingness to receive text messages
- gives consent to access medical records for collection of birth outcome data
Who cannot join
- frank cognitive impairment or psychosis
- not able to communicate in English
- not planning to deliver at a Detroit Medical Center (DMC) hospital
- previous or current participant in a study conducted by Dr. Ondersma
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Perinatal Research Branch participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Marijuana Use in Pregnancy: Planning a Stage II Trial
Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal exposure to marijuana can have lasting negative effects. However, current answers to this problem are failing to reach most women who use marijuana while pregnant. This project will develop and begin testing two technology-based, highly practical interventions that could reduce the number of children who are prenatally exposed to marijuana.
Read the detailed description
There are at present no evidence-based interventions for marijuana use during pregnancy, despite its being by far the most commonly used illicit drug during pregnancy (particularly among African-American women), and despite growing evidence that it may have a range of long-term cognitive and neurobehavioral consequences. This R34 clinical trial planning grant therefore proposes the development and preliminary validation of two high- reach and mutually compatible technology-based interventions for marijuana use during pregnancy. The first, a theory-based, synchronous, and highly interactive computer-delivered brief intervention, will be based on an emerging knowledge base regarding key elements of efficacious technology-delivered interventions. The second intervention, a series of tailored text messages, will build on the rich literature regarding key tailoring elements. These interventions will be developed and refined with input from pregnant women who report active use of marijuana, as well as from health care providers. They will subsequently be tested-alone and in combination-in a pilot randomized trial involving 80 women actively using marijuana during pregnancy. This Stage I pilot work would set the stage for a confirmatory Stage II trial. It would also produce the first high-reach brief interventions for marijuana use during pregnancy. If effective, these approaches could have a substantial population impact on marijuana use among pregnant women, with potential for lifelong improved outcomes for both mother and child.
- Conditions
- Marijuana Use, Pregnancy
- Being tested
- eSBIRT, Tailored texting
- Keywords
- Computerized Brief Intervention
- Medical subject headings
- Marijuana Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSBIRTBehavioural
A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.
Tailored textingBehavioural
Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.
| Study group | Role | What they receive |
|---|---|---|
| electronic SBIRT (eSBIRT) | Experimental | Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting. Receives: Behavioral: eSBIRT |
| Tailored texting | Experimental | Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support. Receives: Behavioral: Tailored texting |
| eSBIRT & texting | Experimental | Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms. Receives: Behavioral: eSBIRT; Behavioral: Tailored texting |
| Assessment only | No intervention | Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention. |
| Screening only | No intervention | Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery
Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.
Measured: self-reported use during 7 days prior to delivery of their baby
Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery
Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.
Measured: self-reported use during 90 days prior to delivery of their baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study start30 Sep 2015
- Primary completion20 Apr 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Marijuana UseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), 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
- NCT02191605
- Sponsor's protocol ID
- R34DA036788
- Other IDs
- 1R34DA036788
- Status last verified
- Jun 2018
- First submitted
- 14 Jul 2014
- Last updated
- 3 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Marijuana Use in Pregnancy: Planning a Stage II Trial
- ClinicalTrials.gov ID
- NCT02191605
- Acronym / sponsor ID
- R34DA036788
- Conditions
- Marijuana Use, Pregnancy
- Keywords
- Computerized Brief Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal exposure to marijuana can have lasting negative effects. However, current answers to this problem are failing to reach most women who use marijuana while pregnant. This project will develop and begin testing two technology-based, highly practical interventions that could reduce the number of children who are prenatally exposed to marijuana.
Detailed description
There are at present no evidence-based interventions for marijuana use during pregnancy, despite its being by far the most commonly used illicit drug during pregnancy (particularly among African-American women), and despite growing evidence that it may have a range of long-term cognitive and neurobehavioral consequences. This R34 clinical trial planning grant therefore proposes the development and preliminary validation of two high- reach and mutually compatible technology-based interventions for marijuana use during pregnancy. The first, a theory-based, synchronous, and highly interactive computer-delivered brief intervention, will be based on an emerging knowledge base regarding key elements of efficacious technology-delivered interventions. The second intervention, a series of tailored text messages, will build on the rich literature regarding key tailoring elements. These interventions will be developed and refined with input from pregnant women who report active use of marijuana, as well as from health care providers. They will subsequently be tested-alone and in combination-in a pilot randomized trial involving 80 women actively using marijuana during pregnancy. This Stage I pilot work would set the stage for a confirmatory Stage II trial. It would also produce the first high-reach brief interventions for marijuana use during pregnancy. If effective, these approaches could have a substantial population impact on marijuana use among pregnant women, with potential for lifelong improved outcomes for both mother and child.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| electronic SBIRT (eSBIRT) | Experimental | Behavioral: eSBIRTParticipants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting. |
| Tailored texting | Experimental | Behavioral: Tailored textingParticipants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support. |
| eSBIRT & texting | Experimental | Behavioral: eSBIRT, Behavioral: Tailored textingParticipants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms. |
| Assessment only | No intervention | –Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention. |
| Screening only | No intervention | –Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 40 years of age
- 20 weeks or less gestation
- intention to carry pregnancy to term
- self-reported marijuana use in month before pregnancy
- own a cell phone and willingness to receive text messages
Key exclusion criteria (5 listed)
- frank cognitive impairment or psychosis
- not able to communicate in English
- not planning to deliver at a Detroit Medical Center (DMC) hospital
- previous or current participant in a study conducted by Dr. Ondersma
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Perinatal Research Branch participant.
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 |
|---|---|---|
| eSBIRTA single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant. | Behavioural | eSBIRT & texting, electronic SBIRT (eSBIRT) |
| Tailored textingGroup text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them. | Behavioural | Tailored texting, eSBIRT & texting |
Primary outcome
Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery
Time frame: self-reported use during 7 days prior to delivery of their baby
Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.
Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery
Time frame: self-reported use during 90 days prior to delivery of their baby
Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 study testing eSBIRT and Tailored texting in people with Marijuana Use and Pregnancy, 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 6 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 3 Jul 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery (time frame: self-reported use during 7 days prior to delivery of their baby). 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 3 Jul 2018.