Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Perinatal smoking cessation treatment and maintenance sessions.
- Who it may be relevant to
- Registry conditions: Perinatal, Cannabis Use, Tobacco Use, Smoking Cessation. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Partnering With Pregnant and Postpartum People to Co-Create a Novel Intervention to Reduce Tobacco and Cannabis Use
Overview
Using both tobacco and cannabis during pregnancy is more common in minoritized groups and can make quitting smoking in pregnancy and remaining smoke free postpartum difficult. Investigators will test an intervention to address prenatal depressive symptoms to encourage people to quit tobacco and cannabis during pregnancy and stay quit postpartum.
Interventions
- Behavioral Perinatal smoking cessation treatment and maintenance sessions
Participants will meet one-on-one with a study interventionist over the course of 6 prenatal treatment sessions and 3 postpartum maintenance sessions. Sessions will include education and discussion on self-monitoring of targets/ problem identification, psychoeducation, behavioral activation, cognitive restructuring, and mindfulness skills.
Primary outcome measures
- Attendance [Time frame: From enrollment to 3 months postpartum]
- Completion of Intervention-Related Procedures [Time frame: From enrollment to 3 months postpartum]
- Acceptability of the Intervention [Time frame: From enrollment to 3 months postpartum]
Secondary outcome measures (5)
- Abstinence from Tobacco Products [Time frame: Baseline assessment to 3 months postpartum]
- Abstinence from Cannabis Products [Time frame: Baseline assessment to 3 months postpartum.]
- Depressive Symptoms from Baseline [Time frame: Baseline assessment to 3 months postpartum]
- Change in Tobacco Use from Baseline [Time frame: Baseline assessment to 3 months postpartum]
- Change in Cannabis Use from Baseline [Time frame: Baseline assessment to 3 months postpartum]
Eligibility criteria
Inclusion criteria
- Confirmed pregnant
- Under 26 weeks gestation
- Plan to remain pregnant
- English speaking
- Use of combustible tobacco at least once a week during pregnancy, or at least once a week in the 3 months before pregnancy if stopped
- Use of cannabis at any frequency during pregnancy or in the 3 months before pregnancy if stopped
Exclusion criteria
- Current opioid use or active treatment for Opioid Use Disorder
- Unable to provide informed consent in English
- Under 18 years old
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Bellefield Towers — Pittsburgh
Identifiers
NCT: NCT07489443 · STUDY25110016 · 1R01DA057946-01A1