E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Nicotine Patch
- Conditions
- Tobacco Smoking
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Change in Smoking as Assessed by Urinary Cotinine Levels
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jin Ho Yoon
Assistant Professor
The University of Texas Health Science Center, Houston
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
Arms & Interventions
Nicotine Replacement Therapy - Nicotine Patch
Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
Intervention: Nicotine Patch
Nicotine Replacement Therapy + 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).
Intervention: Nicotine Patch
Nicotine Replacement Therapy + 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).
Intervention: E-cigarette
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: Baseline, Week 5
Secondary Outcomes
- Feasibility as Assessed by Percent of Participants Who Completed the Study(week 5)