Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373126
Status:
COMPLETED
Last Update Posted:
2009-05-15
First Post:
2006-09-05
Brief Title:
The Effects of Nicotine Withdrawal on Reward Responsivity in Schizophrenia
Sponsor:
North Suffolk Mental Health Association
Organization:
North Suffolk Mental Health Association
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Trial of Reward Responsivity During Nicotine Withdrawal in Smokers With Schizophrenia and Normal Controls
Status:
COMPLETED
Status Verified Date:
2009-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It has been suggested that patients with schizophrenia smoke in order to produce amelioration of dysfunctional dopaminergic pathways allowing them to experience pleasure and satisfaction and overcome anhedonia No studies have assessed the effects of nicotine withdrawal on reward responsivity in patients with schizophrenia The investigators believe that an understanding of this is crucial if improved treatments for nicotine dependence are to be developed for this patient population If this group already has deficits in reward responsivity as a symptom of the disease then they may be particularly prone to the effects of nicotine withdrawal on reward systems Smoking cessation may lead to a further decrease in their responsivity to pleasurable stimuli and worsening anhedonia Treatments for smoking cessation may need to ameliorate any increased deficits if they are likely to be effective in patients with schizophrenia
Detailed Description:
Heavy smoking continues to represent a significant public health problem for people in the general population and for people with major mental illness Twenty-four percent of adults in the general population smoke and it has been estimated that 74-92 of people with schizophrenia smoke While effective treatments for smoking cessation have been developed response rates are modest and relapse rates are high Approximately 70 of people who quit smoking with effective treatments relapse to smoking within one year A syndrome of negative affect and anhedonia has been described as an important component in maintenance of dependence on nicotine It has also been suggested that preventing the syndrome of anhedonia and negative affect during early abstinence may reduce relapse rates If the syndrome of anhedonia can be measured objectively and quantitatively we will be better able to test treatments for this withdrawal syndrome It is our hypothesis that the syndrome of anhedonia during early abstinence from nicotine is quantifiable as a deficit in reward responsivity
Animal studies suggest that nicotine withdrawal is associated with an alteration in reward responsivity Brain stimulation reward thresholds have been used to measure anhedonia and responsivity to reward in animal models Nicotine withdrawal has been associated with a significant decrease in brain reward function as measured by elevations in brain reward thresholds that persist for 4 days Nicotine withdrawal has also been associated with failure of conditioning to an environment paired with novel stimuli possibly due to a decrease in reward associated with novel stimuli Drug withdrawal states have also been associated with inhibition of mesolimbic release in murine models
We propose a randomized placebo controlled trial to investigate the effects of nicotine abstinence on reward responsivity in patients with no major mental illness and in patients with schizophrenia
Principal Aims
Aim 1 To evaluate the effects of nicotine withdrawal on a measure of reward responsivity Hypothesis 1a Normal controls and subjects with schizophrenia will demonstrate deterioration on a measure of reward responsivity during abstinence placebo condition compared to baseline Primary Outcome Measure
Aim 2 To evaluate the effects of transdermal nicotine on reward responsivity during abstinence
Hypothesis 2a Normal controls and subjects with schizophrenia will demonstrate greater response bias toward a rewarded condition following transdermal nicotine administration relative to placebo patch during a 3 day period of abstinence
Aim 3 To evaluate the effects of smoking abstinence and transdermal nicotine on a measure of reward responsivity in patients with schizophrenia who smoke relative to normal control smokers
Hypothesis 3a Subjects with schizophrenia will demonstrate decreased reward responsivity during all conditions baseline nicotine replacement therapy condition and placebo condition relative to normal controls
Secondary aims
Aim 4 To evaluate the effects of nicotine withdrawal on cognitive function in smokers Hypothesis 4a Normal controls and subjects with schizophrenia will demonstrate poorer performance on tests of cognition following placebo administration compared with baseline and nicotine conditions
We propose to test the effects of smoking abstinence and nicotine replacement therapy using nicotine transdermal patch on a measure of reward responsivity in patients who smoke We propose a randomized placebo controlled crossover trial with the primary outcome measure being Response bias using a signal detection task
Subjects are 70 patients with schizophrenia who smoke and 70 normal control smokers who do not have a major mental illness and who are matched for age sex and nicotine dependence Though we expect to consent 70 subjects in each group we expect only 20 subjects in each group to complete the study
Animal studies suggest that nicotine withdrawal is associated with an alteration in reward responsivity Brain stimulation reward thresholds have been used to measure anhedonia and responsivity to reward in animal models Nicotine withdrawal has been associated with a significant decrease in brain reward function as measured by elevations in brain reward thresholds that persist for 4 days Nicotine withdrawal has also been associated with failure of conditioning to an environment paired with novel stimuli possibly due to a decrease in reward associated with novel stimuli Drug withdrawal states have also been associated with inhibition of mesolimbic release in murine models
We propose a randomized placebo controlled trial to investigate the effects of nicotine abstinence on reward responsivity in patients with no major mental illness and in patients with schizophrenia
Principal Aims
Aim 1 To evaluate the effects of nicotine withdrawal on a measure of reward responsivity Hypothesis 1a Normal controls and subjects with schizophrenia will demonstrate deterioration on a measure of reward responsivity during abstinence placebo condition compared to baseline Primary Outcome Measure
Aim 2 To evaluate the effects of transdermal nicotine on reward responsivity during abstinence
Hypothesis 2a Normal controls and subjects with schizophrenia will demonstrate greater response bias toward a rewarded condition following transdermal nicotine administration relative to placebo patch during a 3 day period of abstinence
Aim 3 To evaluate the effects of smoking abstinence and transdermal nicotine on a measure of reward responsivity in patients with schizophrenia who smoke relative to normal control smokers
Hypothesis 3a Subjects with schizophrenia will demonstrate decreased reward responsivity during all conditions baseline nicotine replacement therapy condition and placebo condition relative to normal controls
Secondary aims
Aim 4 To evaluate the effects of nicotine withdrawal on cognitive function in smokers Hypothesis 4a Normal controls and subjects with schizophrenia will demonstrate poorer performance on tests of cognition following placebo administration compared with baseline and nicotine conditions
We propose to test the effects of smoking abstinence and nicotine replacement therapy using nicotine transdermal patch on a measure of reward responsivity in patients who smoke We propose a randomized placebo controlled crossover trial with the primary outcome measure being Response bias using a signal detection task
Subjects are 70 patients with schizophrenia who smoke and 70 normal control smokers who do not have a major mental illness and who are matched for age sex and nicotine dependence Though we expect to consent 70 subjects in each group we expect only 20 subjects in each group to complete the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005P-001753 | None | None | None |