Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00554840
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2007-11-06
Brief Title:
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2022-03
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 proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation Specifically The primary objective of this pilot study is to determine if taking of varenicline along with an individual smoking cessation supportive program is a safe and effective treatment of nicotine addiction in schizophrenic patients We hypothesize that the varenicline treated patients will achieve higher rates of smoking cessation than those who receive placebo and individual support
Detailed Description:
The primary objective of the data analysis will be to measure the rate of smoking cessation in the two treatment groups Smoking cessation will be measured weekly through a composite measure of self-reported abstinence end expired carbon monoxide CO of less than C10 ppm and urine cotinine dipstick measure of 30 ngml The primary endpoint will be point prevalence at 12 weeks The four week continuous abstinence rate for the last four weeks of the treatment phase will also be evaluated The point prevalence abstinence rates will also be obtained The secondary objective is to determine whether smoking cessation is associated with a worsening of cognition and psychiatric symptomology We hypothesize that subjects who achieve abstinence in the varenicline group will not show worsening on neurocognitive and symptom measures compared to abstinence subjects in the placebo group Lastly we will attempt to identify any clinical or topographic markers which predict cessation
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