Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum (PICTURe)

March 17, 2026 updated by: Natacha DeGenna, University of Pittsburgh

Partnering With Pregnant and Postpartum People to Co-Create a Novel Intervention to Reduce Tobacco and Cannabis Use

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Bellefield Towers
        • Contact:
        • Principal Investigator:
          • Natacha De Genna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Feasibility and Acceptability Trial
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance
Time Frame: From enrollment to 3 months postpartum
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
Time Frame: From enrollment to 3 months postpartum
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
Time Frame: From enrollment to 3 months postpartum
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence from Tobacco Products
Time Frame: Baseline assessment to 3 months postpartum
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
Time Frame: Baseline assessment to 3 months postpartum.
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
Time Frame: Baseline assessment to 3 months postpartum
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
Time Frame: Baseline assessment to 3 months postpartum
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
Time Frame: Baseline assessment to 3 months postpartum
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Natacha De Genna, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

February 24, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY25110016
  • 1R01DA057946-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is a small pilot trial and at this time we do not anticipate the need to share IPD to support efficient clinical research and bring benefit to patients. However, if in the conduct of the trial our understanding changes, we will revise our IPD plan.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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