Recruiting

Smoking Cessation

Sponsor:

UCLA

Code:

NCT07129590

Conditions

Smoking Cessation

Tobacco Smoking

Tobacco Use Cessation

Smoking Reduction

Smoking, Cigarette

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Expired carbon monoxide (CO)

Interviews

Questionnaires

Study Details

Brief summary:

Trauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) Realizing the prevalence of trauma and pathways to recovery, (2) Recognizing symptoms of trauma, (3) Responding by embedding knowledge of trauma into practices and policies and (4) Resisting re-traumatization (the 4Rs). In close partnership with Breathe California and a public safety-net clinic in San Francisco that serves primarily racial and ethnic minoritized (REM) pregnant women, the 4Rs along with the Ask, Advise, Assess, Assist and Arrange (the 5As) evidence-based intervention for tobacco cessation that is delivered by health care professionals and is a US Public Health Services clinical practice guideline for treating tobacco will be used to create and implement a smoking cessation intervention for pregnant women with experiences of trauma.

Conditions

Smoking Cessation

Tobacco Smoking

Tobacco Use Cessation

Smoking Reduction

Smoking, Cigarette

Study ID

NCT07129590

Start date

Nov 19, 2025

Status verified date

Apr, 2026

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Clinician Eligibility Criteria (Aims 1 - 3):

In Aims 1-3, will be recruiting clinicians working in our clinic sites.

1. Nurse practitioner, physician assistant, nurse-midwife, medical doctor, registered nurse, clinical pharmacist, behavioral health professional, social worker, or any other healthcare professional caring for pregnant patient-participants.
2. Age ≥ 18 years old.

Patient-participant Eligibility Criteria (Aim 1):

In Aim 1, will be recruiting pregnant women (ages 18+) who:

1. Currently smoking or report having smoked during a previous pregnancy
2. Age ≥18 years old.
3. Currently Pregnant.
4. Identifies as a cisgender woman, or female at birth.
5. Reports having experienced trauma aligned with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition for traumatic exposure.
6. Proficient in English or Spanish languages.

Patient-Participant Eligibility Criteria (Aim 2):

Patient-participants will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.

Inclusion criteria:

1. Current or former patient in the participating clinical sites.
2. Age ≥18 years old.
3. Proficient in English or Spanish languages.

Patient-Participant Eligibility Criteria (Aim 3): In Aim 3, will be recruiting pregnant women who are actively smoking and have histories of trauma (ages 18+).

Inclusion criteria:

1. Currently smoking (ever smoked 100 cigarettes in their lifetime, smoked in the past 7 days and at least 1 cigarette per day, verified by CO≥6ppm)
2. ≥18 years old
3. Currently Pregnant
4. Identifies as a cisgender women, or female at birth
5. Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ)
6. English or Spanish Proficient

Exclusion Criteria:

Clinician- and Patient-participant Exclusion criteria (Aims 1 - 3):

1\. Any condition, including active mental health crises or cognitive impairment, that would interfere with the ability to provide informed consent or safely complete the study.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Aim 1: Development, Pilot Group

Both clinician- and patient-participants will participate in a 60-minute in-depth, semi-structured interview conducted either in-person or via secure University of California, San Francisco (UCSF) video-telephone software.

Interventions

Expired carbon monoxide (CO)

Expired CO will be measured using a non-investigational device

Interviews

Participants will be interviewed via video conference or in person

Questionnaires

Participants will receive questionnaires to complete through the course of the study

Primary outcome measure

  • Number of themes (Aim 1) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Gaby Luna-Victoria, MD, MAS

877-827-3222gaby.lunavictoria@ucsf.edu

Anita Hargrave-Bouagnon

anita.hargrave@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94115

Contacts

Principal Investigator:

Anita Hargrave-Bouagnon, MD, MAS

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Pregnancy

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 California, San Francisco on 2026-04-23.