N/A
N=7
E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Tobacco Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02918630 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Change in Smoking as Assessed by Breath Carbon Monoxide Levels — -18; -4.3 parts per million (ppm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nicotine Patch (Drug); E-cigarette (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Smoking as Assessed by Breath Carbon Monoxide Levels |
-18; -4.3 | — |
| PRIMARY Change in Smoking as Assessed by Urinary Cotinine Levels |
0; 0 | — |
| PRIMARY Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back |
9; 12 | — |
| PRIMARY Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back |
9; 12 | — |
| SECONDARY Feasibility as Assessed by Percent of Participants Who Completed the Study |
100; 100 | — |
Summary
The purpose of this study is to assess if access to an electronic nicotine delivery device, or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among individuals diagnosed with schizophrenia compared to nicotine patch alone.
Eligibility Criteria
Inclusion Criteria
- Be diagnosed with schizophrenia
- Be in stable medical condition (DSM-V)
- report smoking ≥10 tobacco cigarettes/day
- present a breath CO ≥10 ppm
- report wanting to reduce their cigarette smoking
- be fluent in English
- have a stable living situation
Exclusion Criteria
- be currently pregnant or breastfeeding
- report wanting to quit smoking in the immediate future
- test positive for illicit drugs except THC
- have any illness, medical condition, or use of medications, which in the opinion of the study physicians would preclude safe and/or successful completion of the study
Data sourced from ClinicalTrials.gov (NCT02918630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.