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

NCT07489443 | Not Yet Recruiting

• 2 other identifiers: STUDY251100161R01DA057946-01A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (5)

• Abstinence from Tobacco Products

  Baseline assessment to 3 months postpartum

• Abstinence from Cannabis Products

  Baseline assessment to 3 months postpartum.

• Depressive Symptoms from Baseline

  Baseline assessment to 3 months postpartum

• Change in Tobacco Use from Baseline

  Baseline assessment to 3 months postpartum

• Change in Cannabis Use from Baseline

  Baseline assessment to 3 months postpartum

Study Arms (1)

Feasibility and Acceptability Trial

EXPERIMENTAL

Behavioral: Perinatal smoking cessation treatment and maintenance sessions

Interventions

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.

Feasibility and Acceptability Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current opioid use or active treatment for Opioid Use Disorder
• Unable to provide informed consent in English
• Under 18 years old

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Bellefield Towers

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Tobacco Use; Smoking Cessation; Smoking; Marijuana Abuse

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Natacha De Genna

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Coordinator

CONTACT

412-301-3848; parentas@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Epidemiology, Clinical and Translational Science

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)