Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT07489443

Conditions

Perinatal

Cannabis Use

Tobacco Use

Smoking Cessation

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Perinatal smoking cessation treatment and maintenance sessions

Study Details

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.

Conditions

Perinatal

Cannabis Use

Tobacco Use

Smoking Cessation

Study ID

NCT07489443

Start date

Jun 17, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Feasibility and Acceptability Trial

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Project Coordinator

412-301-3848parentas@upmc.edu

Locations

Bellefield Towers

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Project Coordinator

412-301-3848parentas@upmc.edu

Principal Investigator:

Natacha De Genna

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • tobacco
  • perinatal
  • pregnancy
  • smoking
  • cessation
  • postpartum
  • cannabis
  • intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-06.