E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

The University of Texas Health Science Center, Houston7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Tobacco Smoking

Interventions

Nicotine PatchDRUG

Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.

E-cigaretteDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Change in Smoking as Assessed by Breath Carbon Monoxide Levels

Time frame: Baseline, Week 5

Change in Smoking as Assessed by Urinary Cotinine Levels

Time frame: 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.

Time frame: Baseline

Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back

Time frame: week 5

Secondary Outcomes

Feasibility as Assessed by Percent of Participants Who Completed the Study

Time frame: week 5

Data from ClinicalTrials.gov

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