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Trauma-Informed Care for Smoking Cessation for Pregnancy

StatusRecruiting
PhaseNot applicable
Started2025-11-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 31, 2026 → Dec 31, 2026
See other at-risk trials from University of California, San Francisco

Amendment history

2026-09-04
Study Status v5
Primary completion pushed: 2026-07-31 → 2026-12-31
Completion pushed: 2026-07-31 → 2026-12-31
2026-04-20
Study Status, Eligibility v4
Primary completion date2026-03-31→2026-07-31
Completion date2026-03-31→2026-07-31
Eligibility criteria-92 characters
Inclusion Criteria: Clinician Eligibility Criteria (Aims 1 - 3): In Aims 1-3, will be recruiting clinicians working in the Obstetrics, Midwifery, and Gynecology Clinic (5M) safety-netour clinic and the UCSF Community and Clinical Research Center (ZSFG)sites. Nurse practitioner, physician assistant, nurse-midwife, or medical doctor, registered nurse, clinical pharmacist, behavioral health professional, social worker, or any other healthcare professional caring for pregnant patient-participants. Age ≥ 18 years ol [...] iteria (Aim 1): In Aim 1, will be recruiting pregnant women receiving care at the 5M [...] [...]
2025-12-05
Study Status, Eligibility v3
Eligibility criteria+649 characters
Inclusion Criteria: Clinician Eligibility Criteria (Aims 1 - 3): In AimAims 1-3, will be recruiting clinicians working in the Obstetrics, Midwifery, and Gynecology Clinic (5M) safety-net clinic and the UCSF Community and Clinical Research Center (ZSFG). Nurse practitioner, physician assistant, nurse-midwife, or [...] e ≥ 18 years old. Patient-participant Eligibility Criteria (AimsAim 1 & 3): In Aim 1, will be recruiting pregnant women receiving care at the 5M safety-net clinic who are actively smoking and have histories of trauma (ages 18+) Currently smoking (ever smoked 100 cigarettes in their lifet [...] [...]
2025-11-19
Not Yet Recruiting→Recruiting Study Status, Study Description, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-11-15→confirmed 2025-11-19
Study description+50 characters
This study is currently enrolling for Aim 1 only. Study Objectives: Aim 1: Assess barriers to successful mater [...]
Study sitesdetails revised at 1 of 1 site
2025-10-29
Study Status, Contacts/Locations v1
Start date2025-09-01→2025-11-15
Study sitescontacts updated at 1 of 1 site
2025-08-11
Original filing
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.
Trial Details
NCT Number NCT07129590
Lead Sponsor University of California, San Francisco
Collaborators: Tobacco Related Disease Research Program
Conditions Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation, Smoking Reduction, Smoking, Cigarette, Trauma, Psychological, Trauma and Stressor Related Disorders
Enrollment 20 participants
Start Date 2025-11-19
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-10