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Search / Trial NCT05528380

Development of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use

Launched by BUTLER HOSPITAL · Aug 31, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is focused on helping pregnant women who are at risk of using cannabis during their pregnancy. The study aims to create a 12-week program that encourages healthy physical activity while tracking cannabis use. Researchers want to see if this program can help women reduce their cannabis use and improve their overall well-being, including their mental health and ability to cope with stress.

To participate, women must be at least 18 years old, between 12 to 25 weeks pregnant with a healthy baby, and have used cannabis at least once a week in the three months before their pregnancy. They also need to be cleared by a doctor for moderate exercise and want to stop using cannabis. Participants will use a smartphone app to track their activities and receive support throughout the program. It’s important to know that women with certain mental health issues or substance use disorders may not qualify for the study. This trial provides an opportunity for women to improve their health and the health of their baby while getting support from researchers.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Women aged 18+
  • 12-25 weeks gestation with a healthy singleton pregnancy
  • Medically cleared for moderate physical activity
  • Self-report of cannabis use at least once/week in the 3 months prior to the pregnancy desire to not engage in prenatal cannabis use
  • Elevated depression (EPDS\>=7) or anxiety (GAD7\>=5)
  • English-speaking
  • Owns a smartphone to enable use of the Fitbit app
  • Current physical activity does not meet health recommendations (150 min/week mod intensity activity)
  • Expresses interest in reducing or discontinuing cannabis use
  • Exclusion Criteria:
  • Current DSM-5 diagnosis of moderate/severe substance use disorder other than CUD or nicotine use disorder
  • Use of illicit substances in the last 3 months (other than cannabis)
  • Acute psychotic symptoms
  • Current or recent suicidality or homicidally
  • Current anorexia or bulimia
  • Cognitive impairment
  • Physical or medical problems that would not allow safe participation in moderate intensity PA (i.e., not medical cleared by Ob/Gyn)
  • Has a plan to relocate away from the area during study period
  • Recently started new mental health or substance use treatment within past 4 weeks.

About Butler Hospital

Butler Hospital is a leading psychiatric and behavioral health facility dedicated to advancing mental health care through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital focuses on developing and evaluating new therapeutic interventions, aiming to improve treatment outcomes for patients with various mental health conditions. With a commitment to evidence-based practice, Butler Hospital collaborates with a multidisciplinary team of experts to ensure rigorous methodology and ethical standards in all research endeavors, ultimately enhancing the quality of care for individuals in need.

Locations

Providence, Rhode Island, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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