Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261170
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2005-12-01
Brief Title:
Bupropion for Hospital-Based Smoking Cessation
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Bupropion for Hospital-Based Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2008-05
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:
This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion an antidepressant and cognitive-behavioral counseling are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit the hypothesis is that the proportion of quitters who receive the active drugantidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months
Detailed Description:
Two hundred and seventy patients will be enrolledapproximately 135 will be randomized to each study arm over the course of 24 months Patients will be considered smokers if they have used tobacco products during the week prior to admission and if they have smoked or 5 cigarettes day during the previous yearSmokers will be identified by review of admissions and given a flyer to invite them to join the study Interested smokers will be screened and asked to fill out a Beck Depression Inventory Patients with very high Beck Depression Inventory Scores ie or 30 will not be enrolled because such individuals may require other treatment Each patients physician will be contacted to verify hisher eligibility for the study Once eligibility has been ascertained a research associate will visit the patient to obtain informed consent and to enroll them in the study Study questionnaires and a Fagerstrom test for Nicotine Dependence will be completed and reviewed by a research associate for completeness at the time of enrollment The associate will put in the prescription for the study drug and request the order for dispensing of the drug The research pharmacist will randomize the patient to Study Arm 1 or Study Arm 2
Subjects randomized to Study Arm 1 will receive a standard 7-week course of sustained release bupropion 150 mgday for the first 3 days then 150mg BID a self-help booklet counseling on smoking cessation strategies and follow-up phone counseling during the first 3 months after randomization Study Arm 2 participants will receive the same intervention as Study Arm 1 but will receive placebo instead of active bupropion therapy Both study groups will complete study questionnaires regarding their medical and smoking history and will be followed one week after their hospital discharge to record their blood pressure and to monitor possible side effects
Since quit rates tend to decline over time relapse prevention approaches will be included in both study arms Marlatts theory of relapse an extension of Banduras social learning model will be used to augment the quitters perception of self-efficacy Participants will be trained to resist and cope with the temptations and stresses likely to be encountered after discharge from the hospital Behavioral self-management techniques to counter known relapse-triggers such as stress the presence of other smokers alcohol use and depression will be discussed during follow-up counseling calls
We will measure saliva cotinine in all participants who give a history of smoking abstinence at the end of treatment and at 6 months Cotinine levels of or 15 ngmL will be considered evidence of current tobacco use Participants who are self-reported quitters but have failed to provide a saliva sample will be considered as smokers unless verification from a spouse or significant other can be obtained Participants who have died will be analyzed as smokers or quitters based on prior self-report information in medical records or interviews with next-of-kin Others will be censored ie excluded from the analysis All cotinine samples will be assayed at the University of California San Franciscolaboratory of Dr Neal Benowitz
Subjects randomized to Study Arm 1 will receive a standard 7-week course of sustained release bupropion 150 mgday for the first 3 days then 150mg BID a self-help booklet counseling on smoking cessation strategies and follow-up phone counseling during the first 3 months after randomization Study Arm 2 participants will receive the same intervention as Study Arm 1 but will receive placebo instead of active bupropion therapy Both study groups will complete study questionnaires regarding their medical and smoking history and will be followed one week after their hospital discharge to record their blood pressure and to monitor possible side effects
Since quit rates tend to decline over time relapse prevention approaches will be included in both study arms Marlatts theory of relapse an extension of Banduras social learning model will be used to augment the quitters perception of self-efficacy Participants will be trained to resist and cope with the temptations and stresses likely to be encountered after discharge from the hospital Behavioral self-management techniques to counter known relapse-triggers such as stress the presence of other smokers alcohol use and depression will be discussed during follow-up counseling calls
We will measure saliva cotinine in all participants who give a history of smoking abstinence at the end of treatment and at 6 months Cotinine levels of or 15 ngmL will be considered evidence of current tobacco use Participants who are self-reported quitters but have failed to provide a saliva sample will be considered as smokers unless verification from a spouse or significant other can be obtained Participants who have died will be analyzed as smokers or quitters based on prior self-report information in medical records or interviews with next-of-kin Others will be censored ie excluded from the analysis All cotinine samples will be assayed at the University of California San Franciscolaboratory of Dr Neal Benowitz
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 |
|---|---|---|---|
| 12RT-0148 | None | None | None |