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NCT Number: NCT07489443

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bellefield Towers

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Natacha De Genna

PRINCIPAL_INVESTIGATOR

Project Coordinator

CONTACT

[email protected]

412-301-3848

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perinatal smoking cessation treatment and maintenance sessions

Behavioral

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 outcomes

  1. Attendance

    Time frame: From enrollment to 3 months postpartum

    Rate of attendance will be measured by proportion of sessions attended to total available sessions.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Project Coordinator

CONTACT

[email protected]

412-301-3848

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: PICTURe

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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