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Search / Trial NCT06239701

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

Launched by BUTLER HOSPITAL · Jan 26, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking to develop a new program aimed at helping pregnant women reduce their use of cannabis. The study is for women who are between 12 to 25 weeks pregnant, are at least 18 years old, and have been using cannabis at least once a week before their pregnancy. Participants should also be feeling some psychological distress, which will be assessed through simple questionnaires. Women who want to stop using cannabis and are physically able to engage in moderate exercise, like brisk walking, are encouraged to join.

If eligible, participants will be guided through a lifestyle activity program that encourages regular physical activity while using a smartphone app to track their progress. The trial is currently recruiting participants, and it’s important to know that women with certain medical conditions or severe substance use disorders may not qualify. This study is a great opportunity for expectant mothers who are looking to improve their health and the health of their baby by reducing cannabis use during pregnancy.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. women 18+ years of age
  • 2. 12-25 weeks gestation with a healthy singleton pregnancy
  • 3. medically-cleared by their prenatal provider for moderate intensity physical activity
  • 4. self-report of cannabis use at least once/week in the 3 months prior to the current pregnancy and desire to not engage in prenatal CU
  • 5. current psychological distress as defined by Edinburgh Postnatal Depression Scale score \>7 and/or Generalized Anxiety Disorder 7 score \>5)
  • 6. English-speaking
  • 7. owns a smartphone to enable use of the Fitbit app
  • 8. current physical activity level does not meet public health recommendations (less than 150 minutes/week moderate intensity physical activity for the past 3 months)
  • 9. expresses interest in reducing or discontinuing CU
  • Exclusion Criteria:
  • 1. current DSM-5 diagnosis of moderate/severe substance use disorder other than cannabis use disorder or nicotine use disorder
  • 2. use of illicit substances in the last 3 months (other than cannabis)
  • 3. acute psychotic symptoms
  • 4. current or recent suicidality or homicidality
  • 5. current anorexia or bulimia
  • 6. current cognitive impairment
  • 7. physical or medical problems that would not allow safe participation in moderate intensity physical activity
  • 8. has plan to relocate away from the geographic area during the study intervention or assessment period
  • 9. recently started a new form of mental health or substance use treatment within the 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

Trial Officials

Cynthia Battle, PhD

Principal Investigator

Butler Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported