Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00507728
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2007-07-25
Brief Title:
Pharmacogenetics Emotional Reactivity and Smoking
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Pharmacogenetics Emotional Reactivity and Smoking
Status:
COMPLETED
Status Verified Date:
2021-04
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 goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity peak startle response to affective stimuli during a cessation attempt among smokers treated with bupropion varenicline or placebo and to determine if these differences were moderated by genotype
Detailed Description:
Bupropion and Varenicline are smoking cessation aids that may help people to quit smoking
During the orientation visit the study will be explained to you and you will be given an opportunity to ask and have answered any questions you may have You will also be asked to give a buccal cheek cell sample for genetic analysis This session will last about 15 hours
During the screening visit you will be asked questions about your health medication use smoking history and tobacco use You will be asked about any current or past feelings of depression Also a small blood sample will be drawn about 2 tablespoons from your upper arm for a liver and kidney function test and a saliva sample will be collected to measure whether you are smoking Women who are able to have children must have a negative urine pregnancy test This session will last about 25 hours
If you are eligible to take part in the study you will be randomly assigned as in the toss of a coin to one of three treatment groups Participants in the first group will receive Bupropion Participants in the second group will receive Varenicline Participants in the third group will receive a placebo A placebo is a substance that looks like the study drug but which has no active ingredients You will have an equal chance of being assigned to the Bupropion Varenicline or placebo treatment group Neither you nor your counselor will know to which group you were assigned
All participants will take study pills either Bupropion Varenicline or placebo by mouth for 12 weeks The dose of study medication may or may not change during the study You will be responsible for returning any unused used or partly used study medication bottles to a study staff member
All participants will receive smoking cessation counseling to help them quit smoking in the form of both in-person and telephone counseling sessions Some of the counseling sessions may be videotaped or audio-taped The videotapes will be used to help the investigators make sure that the counselors are following the correct procedures and will be erased within one year following your completion of the study No one but the study investigators or those delegated by the study investigators will be allowed to view the tapes and the identity of the participants will be kept strictly confidential Staff that may be given permission to view the tapes include project staff consultants that review and rate how well the study counselors follow guidelines andor consultants that review how well the assessments are given
You will need to come to the Behavioral Science Research Clinic at M D Anderson for 9 clinic visits over an 8-month period You will receive 5 telephone calls from the study staff while in treatment and during follow-up to check on your progress in quitting smoking
You will complete your first lab evaluation session baseline before any treatment begins while you are still smoking Immediately after the baseline lab session on the same day you will begin to receive counseling to quit smoking You will begin taking one of the 3 study medications Bupropion Varenicline or placebo the next morning
There will be 3 lab sessions during which you will be asked to complete questionnaires about your mood and feelings about 30 minutes total Also you will give a breath sample by blowing air into a small tube This sample shows how much you have smoked In each session you will be asked to watch slides and listen to a series of tones through earphones The slides will include pictures of people nature scenes and artwork Slides showing victims of car crashes medical procedures and nude people will also be shown You will be shown examples of these slides before beginning the procedure and given the opportunity to withdraw from the study During the lab sessions your heart rate brain electrical activity EEG skin sweating and muscle tension will be monitored To do this small sensors will be placed on the fingers arms scalp and face You should not drink more than 2 cups of coffee or other caffeine drinks at least 25 hours before each session
During the first counseling visit you will set a quit date for stopping smoking about 2 weeks after starting your study medication You are asked not to quit smoking before the set quit date After your quit date you are asked to stay smoke free You are asked to attend all your sessions whether you are smoking or not All participants will receive smoking cessation counseling in the form of both in-person and telephone counseling sessions The purpose of these visits will be to prepare you for quitting and to check the effects of the study medication on your attempt to stop smoking
At each of your clinic visits your blood pressure will be taken and you will be asked to blow air through a carbon monoxide CO measuring device CO is a gas that is found in higher levels among cigarette smokers At several visits you will be asked to provide a saliva sample to check for cotinine a chemical produced by the breakdown of nicotine during smoking You will be asked to give a saliva sample in a collection tube Like the CO test this test will help researchers measure how much you are smoking
At your visits you will be asked questions about your smoking behavior You will also be asked questions about your health and medical condition and about any medications you are taking You will be asked to complete a daily diary on cigarette smoking and drug dosing
You will also be asked to mail saliva samples back to the clinic at least two times after stopping the medication This will allow researchers to check on your smoking status
Your total participation in this study will last about 8 months This will include a 3-month and 6-month follow-up visit after your scheduled quit date If the study staff is not able to reach you by phone mail or the information provided by your contacts they may try to locate you through telephone directory assistance 411 or internet search sources for example Google or Yahoo which use information from the public domain meaning everyone has access to it If the study staff is still unable to find you they may use a locator service such as Transunion or the National Change of Address NCOA database maintained by the United States Postal Service as a last resort Transunion uses magazine subscriptions and credit applications to find new addresses and the NCOA uses the Change of Address cards filed with the post office when a person moves and requests their mail be forwarded to a new address If the study staff has to use either of these services they would only disclose your name and last known address
At the end of the study you will be able to ask additional questions about the results of the study and about procedures you have experienced during the study Additionally you will be able to sign up to receive a copy of the paper that will be written at the completion of the study
This is an investigational study Up to 375 smokers will take part in this study All will be enrolled at MD Anderson
During the orientation visit the study will be explained to you and you will be given an opportunity to ask and have answered any questions you may have You will also be asked to give a buccal cheek cell sample for genetic analysis This session will last about 15 hours
During the screening visit you will be asked questions about your health medication use smoking history and tobacco use You will be asked about any current or past feelings of depression Also a small blood sample will be drawn about 2 tablespoons from your upper arm for a liver and kidney function test and a saliva sample will be collected to measure whether you are smoking Women who are able to have children must have a negative urine pregnancy test This session will last about 25 hours
If you are eligible to take part in the study you will be randomly assigned as in the toss of a coin to one of three treatment groups Participants in the first group will receive Bupropion Participants in the second group will receive Varenicline Participants in the third group will receive a placebo A placebo is a substance that looks like the study drug but which has no active ingredients You will have an equal chance of being assigned to the Bupropion Varenicline or placebo treatment group Neither you nor your counselor will know to which group you were assigned
All participants will take study pills either Bupropion Varenicline or placebo by mouth for 12 weeks The dose of study medication may or may not change during the study You will be responsible for returning any unused used or partly used study medication bottles to a study staff member
All participants will receive smoking cessation counseling to help them quit smoking in the form of both in-person and telephone counseling sessions Some of the counseling sessions may be videotaped or audio-taped The videotapes will be used to help the investigators make sure that the counselors are following the correct procedures and will be erased within one year following your completion of the study No one but the study investigators or those delegated by the study investigators will be allowed to view the tapes and the identity of the participants will be kept strictly confidential Staff that may be given permission to view the tapes include project staff consultants that review and rate how well the study counselors follow guidelines andor consultants that review how well the assessments are given
You will need to come to the Behavioral Science Research Clinic at M D Anderson for 9 clinic visits over an 8-month period You will receive 5 telephone calls from the study staff while in treatment and during follow-up to check on your progress in quitting smoking
You will complete your first lab evaluation session baseline before any treatment begins while you are still smoking Immediately after the baseline lab session on the same day you will begin to receive counseling to quit smoking You will begin taking one of the 3 study medications Bupropion Varenicline or placebo the next morning
There will be 3 lab sessions during which you will be asked to complete questionnaires about your mood and feelings about 30 minutes total Also you will give a breath sample by blowing air into a small tube This sample shows how much you have smoked In each session you will be asked to watch slides and listen to a series of tones through earphones The slides will include pictures of people nature scenes and artwork Slides showing victims of car crashes medical procedures and nude people will also be shown You will be shown examples of these slides before beginning the procedure and given the opportunity to withdraw from the study During the lab sessions your heart rate brain electrical activity EEG skin sweating and muscle tension will be monitored To do this small sensors will be placed on the fingers arms scalp and face You should not drink more than 2 cups of coffee or other caffeine drinks at least 25 hours before each session
During the first counseling visit you will set a quit date for stopping smoking about 2 weeks after starting your study medication You are asked not to quit smoking before the set quit date After your quit date you are asked to stay smoke free You are asked to attend all your sessions whether you are smoking or not All participants will receive smoking cessation counseling in the form of both in-person and telephone counseling sessions The purpose of these visits will be to prepare you for quitting and to check the effects of the study medication on your attempt to stop smoking
At each of your clinic visits your blood pressure will be taken and you will be asked to blow air through a carbon monoxide CO measuring device CO is a gas that is found in higher levels among cigarette smokers At several visits you will be asked to provide a saliva sample to check for cotinine a chemical produced by the breakdown of nicotine during smoking You will be asked to give a saliva sample in a collection tube Like the CO test this test will help researchers measure how much you are smoking
At your visits you will be asked questions about your smoking behavior You will also be asked questions about your health and medical condition and about any medications you are taking You will be asked to complete a daily diary on cigarette smoking and drug dosing
You will also be asked to mail saliva samples back to the clinic at least two times after stopping the medication This will allow researchers to check on your smoking status
Your total participation in this study will last about 8 months This will include a 3-month and 6-month follow-up visit after your scheduled quit date If the study staff is not able to reach you by phone mail or the information provided by your contacts they may try to locate you through telephone directory assistance 411 or internet search sources for example Google or Yahoo which use information from the public domain meaning everyone has access to it If the study staff is still unable to find you they may use a locator service such as Transunion or the National Change of Address NCOA database maintained by the United States Postal Service as a last resort Transunion uses magazine subscriptions and credit applications to find new addresses and the NCOA uses the Change of Address cards filed with the post office when a person moves and requests their mail be forwarded to a new address If the study staff has to use either of these services they would only disclose your name and last known address
At the end of the study you will be able to ask additional questions about the results of the study and about procedures you have experienced during the study Additionally you will be able to sign up to receive a copy of the paper that will be written at the completion of the study
This is an investigational study Up to 375 smokers will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2012-02108 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearch1R01DA017073 |
| 1R01DA017073 | NIH | None | None |