Back to resultsE-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Primary Purpose
Tobacco Smoking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine Patch
E-cigarette
Sponsored by
About this trial
This is an interventional prevention trial for Tobacco Smoking focused on measuring E-cigarettes, Schizophrenia
Eligibility Criteria
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
Sites / Locations
- University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nicotine Replacement Therapy - Nicotine Patch
Nicotine Replacement Therapy + E-cigarette
Arm Description
Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
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).
Outcomes
Primary Outcome Measures
Change in Smoking as Assessed by Breath Carbon Monoxide Levels
Change in Smoking as Assessed by Urinary Cotinine Levels
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.
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.
Secondary Outcome Measures
Feasibility as Assessed by Percent of Participants Who Completed the Study
Full Information
NCT ID
NCT02918630
First Posted
September 20, 2016
Last Updated
June 5, 2018
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02918630
Brief Title
E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Official Title
E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Smoking
Keywords
E-cigarettes, Schizophrenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nicotine Replacement Therapy - Nicotine Patch
Arm Type
Active Comparator
Arm Description
Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
Arm Title
Nicotine Replacement Therapy + E-cigarette
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Nicotine Patch
Intervention Description
Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
Intervention Type
Drug
Intervention Name(s)
E-cigarette
Intervention 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).
Primary Outcome Measure Information:
Title
Change in Smoking as Assessed by Breath Carbon Monoxide Levels
Time Frame
Baseline, Week 5
Title
Change in Smoking as Assessed by Urinary Cotinine Levels
Time Frame
Baseline, Week 5
Title
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
Description
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
Title
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
Description
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
week 5
Secondary Outcome Measure Information:
Title
Feasibility as Assessed by Percent of Participants Who Completed the Study
Time Frame
week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Ho Yoon, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
12. IPD Sharing Statement
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E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
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