Trauma-Informed Care for Smoking Cessation for Pregnancy
University of California, San Francisco · with Tobacco Related Disease Research Program · NCT07129590
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 20
- US sites recruiting
- 1
- Study start
- November 19, 2025
- Record last updated
- September 10, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Expired carbon monoxide (CO); Interviews; Questionnaires
Conditions: Smoking Cessation; Tobacco Smoking; Tobacco Use Cessation; Smoking Reduction; Smoking, Cigarette; Trauma, Psychological; Trauma and Stressor Related Disorders
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
Clinician Eligibility Criteria (Aims 1 - 3):
In Aims 1-3, will be recruiting clinicians working in our clinic sites.
- 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.
- Age ≥ 18 years old.
Patient-participant Eligibility Criteria (Aim 1):
In Aim 1, will be recruiting pregnant women (ages 18+) who:
- Currently smoking or report having smoked during a previous pregnancy
- Age ≥18 years old.
- Currently Pregnant.
- Identifies as a cisgender woman, or female at birth.
- Reports having experienced trauma aligned with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition for traumatic exposure.
- 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
- Current or former patient in the participating clinical sites.
- Age ≥18 years old.
- 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
- 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)
- ≥18 years old
- Currently Pregnant
- Identifies as a cisgender women, or female at birth
- Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ)
- English or Spanish Proficient
Exclusion Criteria
Clinician- and Patient-participant Exclusion criteria (Aims 1 - 3):
- 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.
Recruiting US locations
Zuckerberg San Francisco General Hospital
San Francisco, CA 94115
Site contact: Gaby Luna-Victoria · gaby.lunavictoria@ucsf.edu
Study contacts (from the official record)
- Gaby Luna-Victoria, MD, MAS · 877-827-3222 · gaby.lunavictoria@ucsf.edu
- Anita Hargrave-Bouagnon · anita.hargrave@ucsf.edu
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