Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280839
Status:
COMPLETED
Last Update Posted:
2012-04-13
First Post:
2005-09-13
Brief Title:
Safety and Efficacy Study of Topiramate to Aid in Smoking Cessation
Sponsor:
Lindner Center of HOPE
Organization:
Lindner Center of HOPE
Study Overview
Official Title:
A Double-Blind Placebo-Controlled 11-Week Trial of Topiramate as an Aid to Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2012-04
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:
The purpose of this research study is to determine if topiramate is safe and effective in the treatment of smoking cessation
Detailed Description:
Cigarette smoking is a pernicious national and global public health problem1 2 Nearly 50 million Americans smoke cigarettes despite widely publicized and acknowledged health warnings and restrictions on public smoking Smoking has been branded as the most important preventable cause of all deaths in the United States US and 45 of smokers will die of tobacco related disorders3 4 Tobacco dependence is mediated in part by the reinforcing effects of nicotine5 According to the US Public Health Service Clinical Practice Guideline Treating Tobacco Use and Dependence every patient attempting to stop smoking should be offered pharmacotherapy for smoking cessation6 Pharmacological treatment strategies have included nicotine replacement therapy NRT nicotine formulations antagonist therapy mecamylamine therapies to make nicotine intake aversive silver acetate non-nicotine medications that mimic some of nicotines neurophysiological effects antidepressants and medications to block craving and withdrawal symptoms nicotine formulations antidepressants clonidine A number of drug therapies for smoking cessation have demonstrated some efficacy in facilitating smoking cessation These include NRT using a variety of nicotine formulations eg pill gum patch etc7-14 combined nicotine replacement and mecamylamine15 the antidepressants bupropion SR16-19 nortriptyline19-21 doxepin22 and fluoxetine23 24 the alpha2 agonist clonidine25-27 and the anxiolytic buspirone28 Among these agents first-line pharmacotherapies approved by the US Food and Drug Administration FDA that include bupropion SR and various NRT products have been found to approximately double long-term abstinence rates compared with placebo29-31 However roughly 7 to 8 out of 10 individuals who use these medications do not achieve long-term abstinence I n addition to the limitations of currently available treatments for smoking cessation several other clinical factors complicate the treatment of nicotine dependence First patients with a history of major depressive disorder appear to have a lower likelihood of achieving sustained smoking abstinence and an increased risk of depressive symptom emergence than patients without a history of major depressive disorder32-44 Second the emergence of prominent mood symptoms associated with nicotine withdrawal eg anxiety dysphoric or depressed mood insomnia irritability and restlessness reduce the likelihood of abstinence35 37 44 Third appetite increases and weight gain are also components of nicotine withdrawal and have negative health consequences30 45 Activation of the mesocorticolimbic dopamine DA system has been implicated in the reinforcing and dependence-producing effects of nicotine46 47 However attempts to ameliorate the symptoms of nicotine dependencewithdrawal using DA receptors as therapeutic targets has met with only modest success48 49 Recent studies in rodents suggest that glutamatergic activation of N-methyl-D-aspartate NMDA receptors within the ventral tegmentum VT may be needed for nicotine to stimulate dopamine release in the nucleus accumbens50-52 These findings are consistent with the reduction of nicotine-induced increases in locomotor activity observed with microinfusion of ionotropic glutamate receptor antagonists53 54 Thus agents that indirectly modulate dopaminergic neurotransmission in the mesocorticolimbic reward circuit via their effects on presynaptic glutamatergic inputs to these dopamine neurons offer promise as novel adjuvants in the treatment of nicotine addiction
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