Trial Outcomes & Findings for The Effects of Nicotine on Cognition in Schizophrenia (NCT NCT00383747)
NCT ID: NCT00383747
Last Updated: 2017-04-28
Results Overview
The primary outcome measure was attention as measured by the Continuous Performance Test Identical Pairs (CPT-IP) Version 4.0 (Biobehavioral Technologies, New York, USA), developed for use in patients with schizophrenia and normal controls. In this task, participants were asked to respond when two identical pairs of numbers were presented in sequence by pressing a mouse key as quickly as possible using the dominant hand.The stimuli were presented with increasing cognitive load in successive blocks: two-,three- and four-digit target in the first, second and third block, respectively. Hit reaction time, a standard outcome variables on the CPTIP, is presented here. It was measured 3 hrs after application of the patch
COMPLETED
PHASE4
60 participants
Visit 1 and visit 2 (separated by an interval of 7-10 days)
2017-04-28
Participant Flow
Non-smoking adults with a DSM IV diagnosis of schizophrenia or schizoaffective disorder, depressed type, were recruited from an urban community mental health clinic. Non-smoking adults without psychiatric illness were recruited using advertising in local press and internet sites. All study procedures took place between January 2005 and July 2006.
Once enrolled, participants attended a baseline visit followed by 2 study days. At the first visit, subjects underwent a training session in the Cognitive Drug Research battery and subjects with schizophrenia completed baseline clinical scales including the Scale for Assessment of Negative Symptoms (SANS) and Positive and Negative Syndrome Scale
Participant milestones
| Measure |
Non-smokers w/Schizophr: Nicotine Patch (V1) Then Placebo (V2)
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
|
Nonsmokers w/Schizophr: Placebo (V1) Then Nicotine Patch (V2)
Non smokers with schizophrenia received Placebo patch application then Nicotine patch: 14mg transdermal nicotine
|
Controls: Nicotine Patch (V1) Then Placebo (V2)
Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch
|
Controls: Placebo (V1) Then Nicotine Patch (V2)
Non-smoking adults without psychiatric illness received placebo patch then nicotine patch 14mg transdermal nicotine application
|
|---|---|---|---|---|
|
Visit 1
STARTED
|
14
|
14
|
16
|
16
|
|
Visit 1
COMPLETED
|
14
|
14
|
16
|
16
|
|
Visit 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Visit 2
STARTED
|
14
|
14
|
16
|
16
|
|
Visit 2
COMPLETED
|
14
|
14
|
16
|
16
|
|
Visit 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Nicotine on Cognition in Schizophrenia
Baseline characteristics by cohort
| Measure |
Non Smokers With Schizophrenia
n=28 Participants
|
Controls
n=32 Participants
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 8 • n=5 Participants
|
40 years
STANDARD_DEVIATION 11 • n=7 Participants
|
43 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 and visit 2 (separated by an interval of 7-10 days)The primary outcome measure was attention as measured by the Continuous Performance Test Identical Pairs (CPT-IP) Version 4.0 (Biobehavioral Technologies, New York, USA), developed for use in patients with schizophrenia and normal controls. In this task, participants were asked to respond when two identical pairs of numbers were presented in sequence by pressing a mouse key as quickly as possible using the dominant hand.The stimuli were presented with increasing cognitive load in successive blocks: two-,three- and four-digit target in the first, second and third block, respectively. Hit reaction time, a standard outcome variables on the CPTIP, is presented here. It was measured 3 hrs after application of the patch
Outcome measures
| Measure |
Non Smokers With Schizophrenia + Nicotine Patch
n=28 Participants
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
|
Non Smokers With Schizophrenia + Placebo Nicotine Patch
n=28 Participants
Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
|
Control + Nicotine Patch
n=32 Participants
Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
|
Controls + Placebo Nicotine Patch
n=32 Participants
Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
|
|---|---|---|---|---|
|
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version
|
2.2 milliseconds
Standard Deviation 0.8
|
2.1 milliseconds
Standard Deviation 0.8
|
3.4 milliseconds
Standard Deviation 0.6
|
3.2 milliseconds
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Visit 1 and visit 2 (separated by an interval of 7-10 days)This standard test of visual attention, processing speed and cognitive interference was performed, in which three cards (Stoelting Co., Wood Dale, IL, USA) were presented in order: the first card with color names, the second with colored patches of ink and the third with color namesprinted in incongruously colored ink. Participants were asked to read or name as many colors as possible in 45 s for each condition. The raw interference score was calculated by subtracting the predicted color-word score (calculated using raw word and color scores) from the observed raw color-word score. This value was converted to an interference T score by referring to a standardized table. A higher interference T score indicates better task performance with less interference. It was measured 3 hrs after application of the patch, after CPT
Outcome measures
| Measure |
Non Smokers With Schizophrenia + Nicotine Patch
n=28 Participants
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
|
Non Smokers With Schizophrenia + Placebo Nicotine Patch
n=28 Participants
Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
|
Control + Nicotine Patch
n=32 Participants
Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
|
Controls + Placebo Nicotine Patch
n=32 Participants
Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
|
|---|---|---|---|---|
|
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Visual Attention and Cognitive Interference as Measured by Three Card Stroop
|
50.4 score
Standard Deviation 5.8
|
49.0 score
Standard Deviation 4.6
|
56.8 score
Standard Deviation 10.3
|
58.8 score
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Visit 1 and visit 2 (separated by an interval of 7-10 days)This measure of working memory and auditory attention was performed under two conditions. In the first condition, participants were read progressively longer lists of letters and numbers and instructed to repeat these exactly as given, without reordering. In the second condition, participants were read progressively longer lists of numbers and letters and instructed to re-order the list and give the numbers first in ascending order and then the letters in alphabetical order (WMS-III). The sum of the trial scores provided the item score and the sum of the item scores provided the total score.It was measured 3 hrs after application of the patch, after CPT and Stroop. The total score ranges from 0 to 21.Higher scores of Letter number sequencing means better working memory and auditory attention
Outcome measures
| Measure |
Non Smokers With Schizophrenia + Nicotine Patch
n=28 Participants
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
|
Non Smokers With Schizophrenia + Placebo Nicotine Patch
n=28 Participants
Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
|
Control + Nicotine Patch
n=32 Participants
Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
|
Controls + Placebo Nicotine Patch
n=32 Participants
Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
|
|---|---|---|---|---|
|
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing
without reorder
|
12.6 units on a scale
Standard Deviation 3.3
|
12.5 units on a scale
Standard Deviation 3.4
|
15.5 units on a scale
Standard Deviation 3.3
|
15.9 units on a scale
Standard Deviation 3.4
|
|
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing
with reorder
|
8.8 units on a scale
Standard Deviation 3.1
|
9.0 units on a scale
Standard Deviation 2.6
|
12.2 units on a scale
Standard Deviation 3.4
|
12.6 units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Visit 1 and visit 2 (separated by an interval of 7-10 days)The Grooved Pegboard (model 32025 Lafayette Instrument Company, Lafayette, IN, USA). In this test of lateralized psychomotor speed, participants had 45 s to place as many pegs as possible into grooves on a board using their dominant hand. The number of correctly placed pegs were recorded for each of the two trials.It was measured 3 hrs after application of the patch after CPT, Stroop and Letter number sequencing
Outcome measures
| Measure |
Non Smokers With Schizophrenia + Nicotine Patch
n=28 Participants
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
|
Non Smokers With Schizophrenia + Placebo Nicotine Patch
n=28 Participants
Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
|
Control + Nicotine Patch
n=32 Participants
Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
|
Controls + Placebo Nicotine Patch
n=32 Participants
Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
|
|---|---|---|---|---|
|
Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard
|
14.4 number of pegs into grooves
Standard Deviation 3.6
|
14.5 number of pegs into grooves
Standard Deviation 3.2
|
19.1 number of pegs into grooves
Standard Deviation 3.2
|
18.6 number of pegs into grooves
Standard Deviation 2.7
|
Adverse Events
Non Smokers With Schizophrenia
Controls
Serious adverse events
| Measure |
Non Smokers With Schizophrenia
n=28 participants at risk
|
Controls
n=32 participants at risk
|
|---|---|---|
|
Immune system disorders
allergic reaction to peanuts
|
3.6%
1/28 • Number of events 1 • Adverse event data was collected at every visit
|
0.00%
0/32 • Adverse event data was collected at every visit
|
|
Psychiatric disorders
deterioration in mental state
|
3.6%
1/28 • Number of events 1 • Adverse event data was collected at every visit
|
0.00%
0/32 • Adverse event data was collected at every visit
|
Other adverse events
| Measure |
Non Smokers With Schizophrenia
n=28 participants at risk
|
Controls
n=32 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • Adverse event data was collected at every visit
|
6.2%
2/32 • Number of events 2 • Adverse event data was collected at every visit
|
|
Gastrointestinal disorders
Nausea
|
7.1%
2/28 • Number of events 2 • Adverse event data was collected at every visit
|
12.5%
4/32 • Number of events 4 • Adverse event data was collected at every visit
|
|
Skin and subcutaneous tissue disorders
skin irritations
|
—
0/0 • Adverse event data was collected at every visit
|
—
0/0 • Adverse event data was collected at every visit
|
|
Nervous system disorders
Dizziness
|
—
0/0 • Adverse event data was collected at every visit
|
—
0/0 • Adverse event data was collected at every visit
|
|
General disorders
Headache
|
—
0/0 • Adverse event data was collected at every visit
|
—
0/0 • Adverse event data was collected at every visit
|
|
General disorders
Palpitations
|
—
0/0 • Adverse event data was collected at every visit
|
—
0/0 • Adverse event data was collected at every visit
|
Additional Information
A. Eden Evins, MD, MPH. Director of the MGH-Harvard Center for Addiction Medicine
Massachusetts General Hospital - Harvard Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place