Clinical trial NCT02191605: Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy
Official title: Computer-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Marijuana Use in Pregnancy: Planning a Stage II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Marijuana Use
Pregnancy
Keywords: Computerized Brief Intervention
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2014-07-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery
timeFrame: self-reported use during 7 days prior to delivery of their baby
measure: Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery
timeFrame: self-reported use during 90 days prior to delivery of their baby
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Steven J Ondersma, PhD
role: PRINCIPAL_INVESTIGATOR
References: