Trial Outcomes & Findings for Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia (NCT NCT01213524)
NCT ID: NCT01213524
Last Updated: 2020-10-19
Results Overview
preferred brand smoke intake (breath CO) after 5-hr "satiation" periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
90 min
Results posted on
2020-10-19
Participant Flow
Participants were recruited from the community using newspaper and other community advertisements.
Participants underwent telephone and in-person screening for eligibility.
Participant milestones
| Measure |
VLNC + NIC
Within-subjects study with 5 conditions that participants underwent in counter-balanced order:
1. Transdermal nicotine replacement + sensorimotor replacement (denicotinized cigarettes)
2. Transdermal nicotine replacement + no sensorimotor replacement
3. Placebo patches + sensorimotor replacement
4. Placebo patches + no sensorimotor replacement
5. Usual brand cigarettes
|
|---|---|
|
Baseline
STARTED
|
75
|
|
Baseline
COMPLETED
|
68
|
|
Baseline
NOT COMPLETED
|
7
|
|
Session 2
STARTED
|
68
|
|
Session 2
COMPLETED
|
63
|
|
Session 2
NOT COMPLETED
|
5
|
|
Session 3
STARTED
|
63
|
|
Session 3
COMPLETED
|
59
|
|
Session 3
NOT COMPLETED
|
4
|
|
Session 4
STARTED
|
59
|
|
Session 4
COMPLETED
|
56
|
|
Session 4
NOT COMPLETED
|
3
|
|
Session 5
STARTED
|
56
|
|
Session 5
COMPLETED
|
56
|
|
Session 5
NOT COMPLETED
|
0
|
|
Session 6
STARTED
|
56
|
|
Session 6
COMPLETED
|
56
|
|
Session 6
NOT COMPLETED
|
0
|
|
Session 7
STARTED
|
56
|
|
Session 7
COMPLETED
|
56
|
|
Session 7
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
VLNC + NIC
Within-subjects study with 5 conditions that participants underwent in counter-balanced order:
1. Transdermal nicotine replacement + sensorimotor replacement (denicotinized cigarettes)
2. Transdermal nicotine replacement + no sensorimotor replacement
3. Placebo patches + sensorimotor replacement
4. Placebo patches + no sensorimotor replacement
5. Usual brand cigarettes
|
|---|---|
|
Baseline
Withdrawal by Subject
|
5
|
|
Baseline
high breath alcohol levels
|
1
|
|
Baseline
Physician Decision
|
1
|
|
Session 2
Withdrawal by Subject
|
5
|
|
Session 3
Withdrawal by Subject
|
4
|
|
Session 4
Physician Decision
|
1
|
|
Session 4
Withdrawal by Subject
|
2
|
Baseline Characteristics
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
Baseline characteristics by cohort
| Measure |
Smokers With Schizophrenia
n=37 Participants
|
Non-Psychiatric Controls
n=38 Participants
Smokers without current psychiatric illness
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
38 participants
n=7 Participants
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 90 minPopulation: Participants who completed all conditions and for whom data are available
preferred brand smoke intake (breath CO) after 5-hr "satiation" periods in which nicotine replacement and sensorimotor replacement were provided under double-blind conditions
Outcome measures
| Measure |
Very Low Nicotine Content Cigarettes + Nicotine Replacement
n=56 Participants
5-hr very low nicotine cigarettes + 42 mg nicotine replacement
|
Very Low Nicotine Content Cigarettes + Placebo
n=56 Participants
5-hr very low nicotine cigarettes + placebo patches
|
No Cigarettes + Nicotine Replacement
n=56 Participants
5-hr 42 mg nicotine replacement only
|
No Cigarettes + Placebo
n=56 Participants
5-hr placebo patches only
|
Usual Brand Cigarettes
n=56 Participants
5-hr use of usual-brand cigarettes
|
|---|---|---|---|---|---|
|
Preferred Brand Smoke Intake (CO)
|
3.30 ppm
Standard Deviation 8.31
|
3.16 ppm
Standard Deviation 10.10
|
9.07 ppm
Standard Deviation 6.95
|
10.54 ppm
Standard Deviation 7.31
|
5.12 ppm
Standard Deviation 10.33
|
SECONDARY outcome
Timeframe: 5 hrPopulation: Participants who completed the study and for whom data were available
Measure of cigarette craving in which 10 items were rated on 100-mm visual analogue scales (0 = "no urge at all", 100 = "strongest urge you've ever had")
Outcome measures
| Measure |
Very Low Nicotine Content Cigarettes + Nicotine Replacement
n=52 Participants
5-hr very low nicotine cigarettes + 42 mg nicotine replacement
|
Very Low Nicotine Content Cigarettes + Placebo
n=52 Participants
5-hr very low nicotine cigarettes + placebo patches
|
No Cigarettes + Nicotine Replacement
n=52 Participants
5-hr 42 mg nicotine replacement only
|
No Cigarettes + Placebo
n=52 Participants
5-hr placebo patches only
|
Usual Brand Cigarettes
n=52 Participants
5-hr use of usual-brand cigarettes
|
|---|---|---|---|---|---|
|
Questionnaire on Smoking Urges - Brief Scale (QSU-Brief)
|
32.02 mm
Standard Deviation 32.74
|
37.92 mm
Standard Deviation 34.94
|
67.08 mm
Standard Deviation 30.33
|
74.13 mm
Standard Deviation 26.47
|
24.48 mm
Standard Deviation 26.73
|
Adverse Events
Smokers With Schizophrenia
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-Psychiatric Controls
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 |
Smokers With Schizophrenia
n=37 participants at risk
|
Non-Psychiatric Controls
n=38 participants at risk
Smokers without current psychiatric illness
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
2.7%
1/37 • Number of events 1
|
0.00%
0/38
|
|
Nervous system disorders
alcohol detoxification
|
2.7%
1/37 • Number of events 1
|
0.00%
0/38
|
|
Psychiatric disorders
suicidality
|
2.7%
1/37 • Number of events 1
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
fall requiring stitches
|
0.00%
0/37
|
2.6%
1/38 • Number of events 1
|
|
General disorders
headache
|
0.00%
0/37
|
2.6%
1/38 • Number of events 1
|
|
Social circumstances
car accident
|
0.00%
0/37
|
2.6%
1/38 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place