E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

The University of Texas System (UT)

Status: Completed

Conditions: Tobacco Smoking

Treatments: Drug: E-cigarette; Drug: Nicotine Patch

Study type: Interventional

Funder types: Other

Identifiers

NCT02918630

HSC-MS-16-0667

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Nicotine Replacement Therapy - Nicotine Patch

Active Comparator group

Description:

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

Treatment:

Drug: Nicotine Patch

Nicotine Replacement Therapy + E-cigarette

Experimental group

Description:

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).

Treatment:

Drug: E-cigarette

Drug: Nicotine Patch