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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA057946-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility and Acceptability Trial | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perinatal smoking cessation treatment and maintenance sessions | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance | Rate of attendance will be measured by proportion of sessions attended to total available sessions. | 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. | 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. | From enrollment to 3 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline assessment to 3 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Project Coordinator | Contact | 412-301-3848 | parentas@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Natacha De Genna | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellefield Towers | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2026 | Feb 24, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| 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. |
| 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. | 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. | 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. | Baseline assessment to 3 months postpartum |
| D001523 |
| Mental Disorders |