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New treatment option for Smoking Cessation
Official title Trauma-Informed Care for Smoking Cessation for Pregnancy
ClinicalTrials.gov ID: NCT07129590
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
See the full eligibility 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...
- 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)...
- 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+).
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.