Trial Outcomes & Findings for E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia (NCT NCT02918630)
NCT ID: NCT02918630
Last Updated: 2018-07-05
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline, Week 5
Results posted on
2018-07-05
Participant Flow
Participant milestones
| Measure |
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: 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).
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
Baseline characteristics by cohort
| Measure |
Nicotine Replacement Therapy - Nicotine Patch
n=4 Participants
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
n=3 Participants
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).
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 4.377 • n=99 Participants
|
44.6 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
48.3 years
STANDARD_DEVIATION 2.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 5Outcome measures
| Measure |
Nicotine Replacement Therapy - Nicotine Patch
n=4 Participants
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
n=3 Participants
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).
|
|---|---|---|
|
Change in Smoking as Assessed by Breath Carbon Monoxide Levels
|
-18 parts per million (ppm)
Standard Deviation 24
|
-4.3 parts per million (ppm)
Standard Deviation 3.1
|
PRIMARY outcome
Timeframe: Baseline, Week 5Outcome measures
| Measure |
Nicotine Replacement Therapy - Nicotine Patch
n=4 Participants
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
n=3 Participants
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).
|
|---|---|---|
|
Change in Smoking as Assessed by Urinary Cotinine Levels
|
0 ng/mL
Standard Deviation 0
|
0 ng/mL
Standard Deviation 0
|
PRIMARY outcome
Timeframe: BaselineTimeline 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.
Outcome measures
| Measure |
Nicotine Replacement Therapy - Nicotine Patch
n=4 Participants
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
n=3 Participants
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).
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
|
13 number of cigarettes per day
Standard Deviation 6
|
23 number of cigarettes per day
Standard Deviation 16
|
PRIMARY outcome
Timeframe: week 5Timeline 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.
Outcome measures
| Measure |
Nicotine Replacement Therapy - Nicotine Patch
n=4 Participants
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
n=3 Participants
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).
|
|---|---|---|
|
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
|
9 number of cigarettes per day
Standard Deviation 7
|
12 number of cigarettes per day
Standard Deviation 7
|
SECONDARY outcome
Timeframe: week 5Outcome measures
| Measure |
Nicotine Replacement Therapy - Nicotine Patch
n=4 Participants
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
n=3 Participants
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).
|
|---|---|---|
|
Feasibility as Assessed by Percent of Participants Who Completed the Study
|
100 percent of participants
|
100 percent of participants
|
Adverse Events
Nicotine Replacement Therapy - Nicotine Patch
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Nicotine Replacement Therapy + E-cigarette
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nicotine Replacement Therapy - Nicotine Patch
n=4 participants at risk
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
n=3 participants at risk
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).
|
|---|---|---|
|
General disorders
Drowsiness
|
100.0%
4/4 • Number of events 4 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Not sleeping well
|
50.0%
2/4 • Number of events 2 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Headache
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Psychiatric disorders
Nervousness
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Eye disorders
Blurry vision
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Dizziness
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Tremor (shaky hands)
|
50.0%
2/4 • Number of events 2 • 5 weeks
|
33.3%
1/3 • Number of events 1 • 5 weeks
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • 5 weeks
|
66.7%
2/3 • Number of events 2 • 5 weeks
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • 5 weeks
|
33.3%
1/3 • Number of events 1 • 5 weeks
|
|
Gastrointestinal disorders
Constipation
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
33.3%
1/3 • Number of events 1 • 5 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Stomach pain (cramps)
|
100.0%
4/4 • Number of events 4 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle aches
|
100.0%
4/4 • Number of events 4 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Cardiac disorders
Heart racing
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Chest pain
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
4/4 • Number of events 4 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Renal and urinary disorders
Increased urination
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Reproductive system and breast disorders
Change in sexual function
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
66.7%
2/3 • Number of events 2 • 5 weeks
|
|
General disorders
Weakness
|
100.0%
4/4 • Number of events 4 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
Skin and subcutaneous tissue disorders
Sweating
|
100.0%
4/4 • Number of events 4 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Dry mouth
|
100.0%
4/4 • Number of events 4 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Fatigue
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
100.0%
3/3 • Number of events 3 • 5 weeks
|
|
General disorders
Difficulty walking
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
66.7%
2/3 • Number of events 2 • 5 weeks
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
25.0%
1/4 • Number of events 1 • 5 weeks
|
33.3%
1/3 • Number of events 1 • 5 weeks
|
|
General disorders
Swelling
|
50.0%
2/4 • Number of events 2 • 5 weeks
|
66.7%
2/3 • Number of events 2 • 5 weeks
|
|
General disorders
Fever/chills
|
0.00%
0/4 • 5 weeks
|
33.3%
1/3 • Number of events 1 • 5 weeks
|
|
General disorders
Loss of appetite
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
66.7%
2/3 • Number of events 2 • 5 weeks
|
|
General disorders
Confusion
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
33.3%
1/3 • Number of events 1 • 5 weeks
|
|
General disorders
Cloudiness
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
66.7%
2/3 • Number of events 2 • 5 weeks
|
|
General disorders
Memory loss
|
75.0%
3/4 • Number of events 3 • 5 weeks
|
66.7%
2/3 • Number of events 2 • 5 weeks
|
Additional Information
Jin Ho Yoon, PhD
The University of Texas Health Science Center at Houston
Phone: (713) 486-2796
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place