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Clinical Trial NCT07489443 (PICTURe) for Perinatal, Cannabis Use, Tobacco Use, Smoking Cessation is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum (PICTURe) 25 Postpartum
Clinical Trial NCT07489443 (PICTURe) is an interventional study for Perinatal, Cannabis Use, Tobacco Use, Smoking Cessation and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 25 participants. Led by University of Pittsburgh, this study is expected to complete by 1 October 2027. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief Summary
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.
Official Title
Partnering With Pregnant and Postpartum People to Co-Create a Novel Intervention to Reduce Tobacco and Cannabis Use
Conditions
PerinatalCannabis UseTobacco UseSmoking CessationOther Study IDs
- PICTURe
- STUDY25110016
- 1R01DA057946-01A1 (U.S. NIH Grant/Contract)
NCT ID Number
Start Date (Actual)
2026-04
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-10
Enrollment (Estimated)
25
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
tobacco
perinatal
pregnancy
smoking
cessation
postpartum
cannabis
intervention
perinatal
pregnancy
smoking
cessation
postpartum
cannabis
intervention
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalFeasibility and Acceptability Trial | 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
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Attendance | Rate of attendance will be measured by proportion of sessions attended to total available sessions. | From enrollment to 3 months postpartum |
Completion of Intervention-Related Procedures | Participant will complete activities designed to help them self-monitor their smoking-related behaviors during and between scheduled treatment sessions. Completion of activities will be measured by the proportion of completed activities to the total number of assigned activities. | From enrollment to 3 months postpartum |
Acceptability of the Intervention | Participants' acceptance of the intervention will be measured using the Acceptability of Intervention Measure (AIM) at the 3-month postpartum assessment. This is a 4-item questionnaire with a scale range of 4-20, with a higher score indicating greater acceptance. | From enrollment to 3 months postpartum |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Abstinence from Tobacco Products | Abstinence from tobacco products will be measured by proportion of the participants who self-report no use of tobacco and by calculating the proportion of participants with negative urine screens for cotinine at the 3-month postpartum assessment. | Baseline assessment to 3 months postpartum |
Abstinence from Cannabis Products | Abstinence from cannabis products will be measured by proportion of the participants who self-report no use of cannabis and by calculating the proportion of participants with negative urine screens for THC at the 3-month postpartum assessment. | Baseline assessment to 3 months postpartum. |
Depressive Symptoms from Baseline | Change in depressive symptoms will be measured through self-report Edinburgh Postnatal Depression Scale (EPDS) at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments. The scale range is 0-30, with a higher score indicating higher depression. | Baseline assessment to 3 months postpartum |
Change in Tobacco Use from Baseline | Change in tobacco use from baseline will be measured through a self-reported smoking questionnaire given at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments. | Baseline assessment to 3 months postpartum |
Change in Cannabis Use from Baseline | Change in cannabis use from baseline will be measured through a self-reported smoking questionnaire given at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments. | Baseline assessment to 3 months postpartum |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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
- Current opioid use or active treatment for Opioid Use Disorder
- Unable to provide informed consent in English
- Under 18 years old
Study Responsible Party
Natacha DeGenna, Principal Investigator, Associate Professor of Psychiatry, Epidemiology, Clinical and Translational Science, University of Pittsburgh
Study Central Contact
Contact: Project Coordinator, 412-301-3848, [email protected]
1 Study Locations in 1 Countries
Pennsylvania
Bellefield Towers, Pittsburgh, Pennsylvania, 15213, United States
Project Coordinator, Contact, 412-301-3848, [email protected]
Natacha De Genna, Principal Investigator