PerinatalPICTUReNCT07489443
Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum
A study testing Perinatal smoking cessation treatment and maintenance sessions in people with Perinatal and Cannabis Use, run by University of Pittsburgh at 1 site in United States.
Trial summary
Using both tobacco and cannabis during pregnancy is more common in minoritized groups and can make quitting smoking in pregnancy and remaining smoke free postpartum difficult. Investigators will test an intervention to address prenatal depressive symptoms to encourage people to quit tobacco and cannabis during… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal, Cannabis Use, Tobacco Use
- What is being tested?
- Perinatal smoking cessation treatment and maintenance sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to Oct 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed pregnant
- Under 26 weeks gestation
- Plan to remain pregnant
- English speaking
- Use of combustible tobacco at least once a week during pregnancy, or at least once a week in the 3 months before pregnancy if stopped
- Use of cannabis at any frequency during pregnancy or in the 3 months before pregnancy if stopped
Who cannot join
- Current opioid use or active treatment for Opioid Use Disorder
- Unable to provide informed consent in English
- Under 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bellefield Towers
Pittsburgh, Pennsylvania, 15213
Project Coordinator, 412-301-3848, parentas@upmc.edu
Natacha De Genna
About this study
Official title: Partnering With Pregnant and Postpartum People to Co-Create a Novel Intervention to Reduce Tobacco and Cannabis Use
Using both tobacco and cannabis during pregnancy is more common in minoritized groups and can make quitting smoking in pregnancy and remaining smoke free postpartum difficult. Investigators will test an intervention to address prenatal depressive symptoms to encourage people to quit tobacco and cannabis during pregnancy and stay quit postpartum.
- Conditions
- Perinatal, Cannabis Use, Tobacco Use, Smoking Cessation
- Being tested
- Perinatal smoking cessation treatment and maintenance sessions
- Keywords
- tobacco, perinatal, pregnancy, smoking, cessation, postpartum, cannabis, intervention
- Medical subject headings
- Tobacco Use, Smoking Cessation, Smoking, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perinatal smoking cessation treatment and maintenance sessionsBehavioural
Participants will meet one-on-one with a study interventionist over the course of 6 prenatal treatment sessions and 3 postpartum maintenance sessions. Sessions will include education and discussion on self-monitoring of targets/ problem identification, psychoeducation, behavioral activation, cognitive restructuring, and mindfulness skills.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility and Acceptability Trial | Experimental | Not described Receives: Behavioral: Perinatal smoking cessation treatment and maintenance sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance
Rate of attendance will be measured by proportion of sessions attended to total available sessions.
Measured: From enrollment to 3 months postpartum
Completion of Intervention-Related Procedures
Participant will complete activities designed to help them self-monitor their smoking-related behaviors during and between scheduled treatment sessions. Completion of activities will be measured by the proportion of completed activities to the total number of assigned activities.
Measured: From enrollment to 3 months postpartum
Acceptability of the Intervention
Participants' acceptance of the intervention will be measured using the Acceptability of Intervention Measure (AIM) at the 3-month postpartum assessment. This is a 4-item questionnaire with a scale range of 4-20, with a higher score indicating greater acceptance.
Measured: From enrollment to 3 months postpartum
Secondary outcomes (5)
Abstinence from Tobacco Products
Abstinence from tobacco products will be measured by proportion of the participants who self-report no use of tobacco and by calculating the proportion of participants with negative urine screens for cotinine at the 3-month postpartum assessment.
Measured: Baseline assessment to 3 months postpartum
Abstinence from Cannabis Products
Abstinence from cannabis products will be measured by proportion of the participants who self-report no use of cannabis and by calculating the proportion of participants with negative urine screens for THC at the 3-month postpartum assessment.
Measured: Baseline assessment to 3 months postpartum.
Depressive Symptoms from Baseline
Change in depressive symptoms will be measured through self-report Edinburgh Postnatal Depression Scale (EPDS) at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments. The scale range is 0-30, with a higher score indicating higher depression.
Measured: Baseline assessment to 3 months postpartum
Change in Tobacco Use from Baseline
Change in tobacco use from baseline will be measured through a self-reported smoking questionnaire given at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments.
Measured: Baseline assessment to 3 months postpartum
Change in Cannabis Use from Baseline
Change in cannabis use from baseline will be measured through a self-reported smoking questionnaire given at baseline assessment, pre-delivery treatment session, and 1 and 3 months postpartum assessments.
Measured: Baseline assessment to 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start17 Jun 2026
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerinatalStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Natacha DeGenna, University of Pittsburgh
- Investigators
- Natacha De Genna, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489443
- Sponsor's protocol ID
- STUDY25110016
- Other IDs
- 1R01DA057946-01A1
- Acronym
- PICTURe
- Status last verified
- Jul 2026
- First submitted
- 24 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a small pilot trial and at this time we do not anticipate the need to share IPD to support efficient clinical research and bring benefit to patients. However, if in the conduct of the trial our understanding changes, we will revise our IPD plan.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnering With Pregnant and Postpartum People to Co-Create a Novel Intervention to Reduce Tobacco and Cannabis Use
- ClinicalTrials.gov ID
- NCT07489443
- Acronym / sponsor ID
- PICTURe / STUDY25110016
- Conditions
- Perinatal, Cannabis Use, Tobacco Use, Smoking Cessation
- Keywords
- tobacco, perinatal, pregnancy, smoking, cessation, postpartum, cannabis, intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Mar 2026 (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.
Using both tobacco and cannabis during pregnancy is more common in minoritized groups and can make quitting smoking in pregnancy and remaining smoke free postpartum difficult. Investigators will test an intervention to address prenatal depressive symptoms to encourage people to quit tobacco and cannabis during pregnancy and stay quit postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility and Acceptability Trial | Experimental | Behavioral: Perinatal smoking cessation treatment and maintenance sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed pregnant
- Under 26 weeks gestation
- Plan to remain pregnant
- English speaking
- Use of combustible tobacco at least once a week during pregnancy, or at least once a week in the 3 months before pregnancy if stopped
Key exclusion criteria (3 listed)
- Current opioid use or active treatment for Opioid Use Disorder
- Unable to provide informed consent in English
- Under 18 years old
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 |
|---|---|---|
| Perinatal smoking cessation treatment and maintenance sessionsParticipants will meet one-on-one with a study interventionist over the course of 6 prenatal treatment sessions and 3 postpartum maintenance sessions. Sessions will include education and discussion on self-monitoring of targets/ problem identification, psychoeducation, behavioral activation, cognitive restructuring, and mindfulness skills. | Behavioural | Feasibility and Acceptability Trial |
Primary outcome
Attendance
Time frame: From enrollment to 3 months postpartum
Rate of attendance will be measured by proportion of sessions attended to total available sessions.
Completion of Intervention-Related Procedures
Time frame: From enrollment to 3 months postpartum
Participant will complete activities designed to help them self-monitor their smoking-related behaviors during and between scheduled treatment sessions. Completion of activities will be measured by the proportion of completed activities to the total number of assigned activities.
Acceptability of the Intervention
Time frame: From enrollment to 3 months postpartum
Participants' acceptance of the intervention will be measured using the Acceptability of Intervention Measure (AIM) at the 3-month postpartum assessment. This is a 4-item questionnaire with a scale range of 4-20, with a higher score indicating greater acceptance.
5 secondary outcomes
Abstinence from Tobacco Products
Time frame: Baseline assessment to 3 months postpartum
Abstinence from Cannabis Products
Time frame: Baseline assessment to 3 months postpartum.
Depressive Symptoms from Baseline
Time frame: Baseline assessment to 3 months postpartum
Change in Tobacco Use from Baseline
Time frame: Baseline assessment to 3 months postpartum
Change in Cannabis Use from Baseline
Time frame: Baseline assessment to 3 months postpartum
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 6 Jul 2026.
- Individual participant dataSharing planned: Undecided. This is a small pilot trial and at this time we do not anticipate the need to share IPD to support efficient clinical research and bring benefit to patients. However, if in the conduct of the trial our understanding changes, we will revise our IPD plan.
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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.
Natacha De Genna principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perinatal smoking cessation treatment and maintenance sessions in people with Perinatal and Cannabis Use, run by University of Pittsburgh 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 6 inclusion and 3 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 6 Jul 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 Project Coordinator (412-301-3848, parentas@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: From enrollment to 3 months postpartum). The study lists 3 primary outcomes in all. 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 6 Jul 2026.