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Trial record 36 of 3313 for:    schizophrenia

The Effects of Nicotine on Cognition in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00383747
Recruitment Status : Completed
First Posted : October 3, 2006
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Collaborators:
Stanley Medical Research Institute
North Suffolk Mental Health Association
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: transdermal nicotine patch
Drug: Transdermal Nicotine Patch
Enrollment 60
Recruitment Details 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.
Pre-assignment Details 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
Arm/Group Title Non-smokers w/Schizophr: Nicotine Patch (V1) Then Placebo (V2) Nonsmokers w/Schizophr: Placebo (V1) Then Nicotine Patch (V2) Controls: Nicotine Patch (V1) Then Placebo (V2) Controls: Placebo (V1) Then Nicotine Patch (V2)
Hide Arm/Group Description Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch Non smokers with schizophrenia received Placebo patch application then Nicotine patch: 14mg transdermal nicotine Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application then placebo patch Non-smoking adults without psychiatric illness received placebo patch then nicotine patch 14mg transdermal nicotine application
Period Title: Visit 1
Started 14 14 16 16
Completed 14 14 16 16
Not Completed 0 0 0 0
Period Title: Visit 2
Started 14 14 16 16
Completed 14 14 16 16
Not Completed 0 0 0 0
Arm/Group Title Non Smokers With Schizophrenia Controls Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 28 32 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 32 participants 60 participants
47  (8) 40  (11) 43  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 32 participants 60 participants
Female
12
  42.9%
15
  46.9%
27
  45.0%
Male
16
  57.1%
17
  53.1%
33
  55.0%
1.Primary Outcome
Title 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
Hide Description 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
Time Frame Visit 1 and visit 2 (separated by an interval of 7-10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non Smokers With Schizophrenia + Nicotine Patch Non Smokers With Schizophrenia + Placebo Nicotine Patch Control + Nicotine Patch Controls + Placebo Nicotine Patch
Hide Arm/Group Description:
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication + transdermal nicotine patch: 14mg transdermal nicotine application
Non smokers with schizophrenia + Placebo transdermal nicotine patch: 14mg transdermal nicotine application
Non-smoking adults without psychiatric illness + transdermal nicotine patch: 14mg transdermal nicotine application
Non-smoking adults without psychiatric illness + placebo transdermal nicotine patch: 14mg transdermal nicotine application
Overall Number of Participants Analyzed 28 28 32 32
Mean (Standard Deviation)
Unit of Measure: milliseconds
2.2  (0.8) 2.1  (0.8) 3.4  (0.6) 3.2  (0.6)
2.Secondary Outcome
Title 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
Hide Description 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
Time Frame Visit 1 and visit 2 (separated by an interval of 7-10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-smokers With Schizophrenia + Nicotine Patch Nonsmokers With Schizophrenia +, Placebo Control + Nicotine Patch Control + Placebo
Hide Arm/Group Description:
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
Non smokers with schizophrenia received Placebo patch application
Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
Non-smoking adults without psychiatric illness received placebo patch
Overall Number of Participants Analyzed 28 28 32 32
Mean (Standard Deviation)
Unit of Measure: score
50.4  (5.8) 49.0  (4.6) 56.8  (10.3) 58.8  (10.0)
3.Secondary Outcome
Title Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing
Hide Description 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
Time Frame Visit 1 and visit 2 (separated by an interval of 7-10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-smokers With Schizophrenia + Nicotine Patch Nonsmokers With Schizophrenia + Placebo Control + Nicotine Patch Control + Placebo
Hide Arm/Group Description:
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
Non smokers with schizophrenia received Placebo patch application
Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
Non-smoking adults without psychiatric illness received placebo patch
Overall Number of Participants Analyzed 28 28 32 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
without reorder 12.6  (3.3) 12.5  (3.4) 15.5  (3.3) 15.9  (3.4)
with reorder 8.8  (3.1) 9.0  (2.6) 12.2  (3.4) 12.6  (3.1)
4.Secondary Outcome
Title Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard
Hide Description 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
Time Frame Visit 1 and visit 2 (separated by an interval of 7-10 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-smokers With Schizophrenia + Nicotine Patch Nonsmokers With Schizophrenia + Placebo Control + Nicotine Patch Control + Placebo
Hide Arm/Group Description:
Nonsmokers with schizophrenia on a stable dose of antipsychotic medication received first transdermal nicotine patch: 14mg transdermal nicotine application
Non smokers with schizophrenia received Placebo patch application
Non-smoking adults without psychiatric illness received transdermal nicotine patch: 14mg transdermal nicotine application
Non-smoking adults without psychiatric illness received placebo patch
Overall Number of Participants Analyzed 28 28 32 32
Mean (Standard Deviation)
Unit of Measure: number of pegs into grooves
14.4  (3.6) 14.5  (3.2) 19.1  (3.2) 18.6  (2.7)
Time Frame Adverse event data was collected at every visit
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non Smokers With Schizophrenia Controls
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Non Smokers With Schizophrenia Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Non Smokers With Schizophrenia Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/28 (7.14%)      0/32 (0.00%)    
Immune system disorders     
allergic reaction to peanuts  1/28 (3.57%)  1 0/32 (0.00%)  0
Psychiatric disorders     
deterioration in mental state  1/28 (3.57%)  1 0/32 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Non Smokers With Schizophrenia Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/28 (10.71%)      6/32 (18.75%)    
Gastrointestinal disorders     
Vomiting  1/28 (3.57%)  1 2/32 (6.25%)  2
Nausea  2/28 (7.14%)  2 4/32 (12.50%)  4
General disorders     
Headache [1]  0/0  0 0/0  0
Palpitations [2]  0/0  0 0/0  0
Nervous system disorders     
Dizziness [3]  0/0  0 0/0  0
Skin and subcutaneous tissue disorders     
skin irritations [4]  0/0  0 0/0  0
[1]
Mild adverse events have been reported in aggregate, unblinded data is not available at this point. Mild adverse events also included headache (11 subjects)
[2]
Mild adverse events have been reported in aggregate, unblinded data is not available at this point. Mild adverse events also included palpitations (seven subjects).
[3]
Mild adverse events have been reported in aggregate, unblinded data is not available at this point. Mild adverse events also included dizziness (14 subjects)
[4]
Mild adverse events have been reported in aggregate, unblinded data is not available at this point. Mild adverse events included minor skin irritations (17 subjects)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: A. Eden Evins, MD, MPH. Director of the MGH-Harvard Center for Addiction Medicine
Organization: Massachusetts General Hospital - Harvard Medical School
Phone: 6176434679
EMail: a_eden_evins@hms.harvard.edu
Layout table for additonal information
Responsible Party: A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00383747     History of Changes
Other Study ID Numbers: 04T574
CORRC 07-2004 ( Other Identifier: North Suffolk Mental Health Association CORRC )
First Submitted: September 29, 2006
First Posted: October 3, 2006
Results First Submitted: April 15, 2015
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017