E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

Study Overview
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Brief Summary
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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.

Official Title
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E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Drug: Nicotine Patch
* Drug: E-cigarette


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nicotine Replacement Therapy - Nicotine Patch<br>Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. | Drug: Nicotine Patch<br>* Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.<br>|
| Experimental: Nicotine Replacement Therapy + E-cigarette<br>The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA). | Drug: Nicotine Patch<br>* Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.<br>Drug: E-cigarette<br>* The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Smoking as Assessed by Breath Carbon Monoxide Levels |  | Baseline, Week 5 | 
| Change in Smoking as Assessed by Urinary Cotinine Levels |  | Baseline, Week 5 | 
| Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below. | Baseline | 
| Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back | Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below. | week 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as Assessed by Percent of Participants Who Completed the Study |  | week 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E-cigarettes, Schizophrenia