NCT07129590 Trauma-Informed Care for Smoking Cessation for Pregnancy
| NCT ID | NCT07129590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Smoking Cessation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-11-19 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Anita Hargrave-Bouagnon, MD, MAS
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07129590 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Smoking Cessation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07129590 currently recruiting?
Yes, NCT07129590 is actively recruiting participants. Contact the research team at gaby.lunavictoria@ucsf.edu for enrollment information.
Where is the NCT07129590 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT07129590 clinical trial?
NCT07129590 is sponsored by University of California, San Francisco. The principal investigator is Anita Hargrave-Bouagnon, MD, MAS at University of California, San Francisco. The trial plans to enroll 20 participants.