Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy

Pregnancy Clinical Trial

Official title:

Computer-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Marijuana Use in Pregnancy: Planning a Stage II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191605
• Other study ID #: R34DA036788
• Secondary ID: 1R34DA036788
• Status: Completed
• Phase: N/A
• Start date: September 30, 2015
• Est. completion date: October 27, 2017

Study information

• Verified date: June 2018
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 27, 2017
• Est. primary completion date: April 20, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Use
• Pregnancy

Intervention

Behavioral:
• eSBIRT
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 texting
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.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Wayne State University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	self-reported use during 7 days prior to delivery of their baby
Primary	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.	self-reported use during 90 days prior to delivery of their baby