E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

Not Applicable

Completed

• Conditions: Tobacco Smoking
• Interventions: Drug: Nicotine Patch; Drug: E-cigarette

• Registration Number: NCT02918630
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Study Start: 2016-10
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-06
• Results First Submitted: 2018-06-05
• Results First Submitted QC: 2018-06-05
• Last Update Submitted: 2018-06-05
• Results First Posted: 2018-07-05
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement Therapy - Nicotine Patch	Nicotine Patch	Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
Nicotine Replacement Therapy + E-cigarette	Nicotine Patch	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).
Nicotine Replacement Therapy + E-cigarette	E-cigarette	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).

Primary Outcome Measures

Name	Time	Method
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	week 5	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.
Change in Smoking as Assessed by Breath Carbon Monoxide Levels	Baseline, Week 5

Secondary Outcome Measures

Name	Time	Method
Feasibility as Assessed by Percent of Participants Who Completed the Study	week 5

Trial Locations

Locations (1)

University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States