Smoking CessationNCT07129590
Trauma-Informed Care for Smoking Cessation for Pregnancy
A study testing Expired carbon monoxide (CO), Interviews and Questionnaires in people with Smoking Cessation and Tobacco Smoking, run by University of California, San Francisco at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation
- What is being tested?
- Expired carbon monoxide (CO), Interviews and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 24Show fewer
- 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.
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anita Hargrave-Bouagnon contact
United States1 site, 1 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94115
Gaby Luna-Victoria, gaby.lunavictoria@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)
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.
Read the detailed description
This study is currently enrolling for Aim 1 only.
Study Objectives:
Aim 1: Assess barriers to successful maternal tobacco cessation for women with trauma and identify targets for intervention through interviewing pregnant women with trauma and clinicians in the safety-net using the Behavior Change Wheel (BCW), a validated implementation science behavior change framework.
Aim 2: Evaluate and adapt an evidence-based tobacco cessation intervention using the for pregnant women by incorporating trauma-informed approaches (the 4Rs) with the established 5As. Input will lead to the effective adaptation and creation of the final TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE) Pregnancy intervention to be tested in Aim 3.
Aim 3: Determine the feasibility and acceptability of the RISE Pregnancy intervention and protocol.
OUTLINE:
This study is currently enrolling for Aim 1 only.
Aim 1: Pregnant women in the safety-net who smoke and have histories of trauma, and clinicians will be interviewed using the BCW to assess barriers to smoking cessation and inform design of a smoking cessation intervention which will be used to inform the design of a smoking cessation intervention (RISE Pregnancy) for evaluation in Aim 2.
- Conditions
- Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation, Smoking Reduction, Smoking, Cigarette, Trauma, Psychological
- Being tested
- Expired carbon monoxide (CO), Interviews, Questionnaires
- Keywords
- Pregnancy
- Medical subject headings
- Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation, Smoking Reduction, Cigarette Smoking, Psychological Trauma, Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expired carbon monoxide (CO)Other
Also called Exhaled CO
Expired CO will be measured using a non-investigational device
InterviewsOther
Also called Participant Interviews
Participants will be interviewed via video conference or in person
QuestionnairesOther
Also called Surveys
Participants will receive questionnaires to complete through the course of the study
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Development, Pilot Group | Experimental | 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. Receives: Other: Expired carbon monoxide (CO); Other: Interviews; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of themes (Aim 1)
Themes related to how to improve smoking cessation for pregnant people will be identified through in-depth interviews.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start19 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Sponsor
- Investigators
- Anita Hargrave-Bouagnon, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129590
- Sponsor's protocol ID
- 25634
- Other IDs
- NCI-2025-05151
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)
- ClinicalTrials.gov ID
- NCT07129590
- Acronym / sponsor ID
- 25634
- Conditions
- Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation, Smoking Reduction, Smoking, Cigarette, Trauma, Psychological
- Keywords
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is currently enrolling for Aim 1 only.
Study Objectives:
Aim 1: Assess barriers to successful maternal tobacco cessation for women with trauma and identify targets for intervention through interviewing pregnant women with trauma and clinicians in the safety-net using the Behavior Change Wheel (BCW), a validated implementation science behavior change framework.
Aim 2: Evaluate and adapt an evidence-based tobacco cessation intervention using the for pregnant women by incorporating trauma-informed approaches (the 4Rs) with the established 5As. Input will lead to the effective adaptation and creation of the final TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE) Pregnancy intervention to be tested in Aim 3.
Aim 3: Determine the feasibility and acceptability of the RISE Pregnancy intervention and protocol.
OUTLINE:
This study is currently enrolling for Aim 1 only.
Aim 1: Pregnant women in the safety-net who smoke and have histories of trauma, and clinicians will be interviewed using the BCW to assess barriers to smoking cessation and inform design of a smoking cessation intervention which will be used to inform the design of a smoking cessation intervention (RISE Pregnancy) for evaluation in Aim 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Development, Pilot Group | Experimental | Other: Expired carbon monoxide (CO), Other: Interviews, Other: QuestionnairesBoth 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
- Currently smoking or report having smoked during a previous pregnancy
- Age ≥18 years old.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expired carbon monoxide (CO)Also: Exhaled COExpired CO will be measured using a non-investigational device | Other | Aim 1: Development, Pilot Group |
| InterviewsAlso: Participant InterviewsParticipants will be interviewed via video conference or in person | Other | Aim 1: Development, Pilot Group |
| QuestionnairesAlso: SurveysParticipants will receive questionnaires to complete through the course of the study | Other | Aim 1: Development, Pilot Group |
Primary outcome
Number of themes (Aim 1)
Time frame: Up to 6 months
Themes related to how to improve smoking cessation for pregnant people will be identified through in-depth interviews.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anita Hargrave-Bouagnon contact
Anita Hargrave-Bouagnon, MD, MAS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expired carbon monoxide (CO), Interviews and Questionnaires in people with Smoking Cessation and Tobacco Smoking, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gaby Luna-Victoria, MD, MAS (877-827-3222, gaby.lunavictoria@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of themes (Aim 1) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.