E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

Tobacco Smoking Clinical Trial

Official title:

E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918630
• Other study ID #: HSC-MS-16-0667
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2017

Study information

• Verified date: June 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia
• Tobacco Smoking

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Smoking as Assessed by Breath Carbon Monoxide Levels		Baseline, Week 5
Primary	Change in Smoking as Assessed by Urinary Cotinine Levels		Baseline, Week 5
Primary	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
Primary	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	Feasibility as Assessed by Percent of Participants Who Completed the Study		week 5