Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
646 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-12-08
Study Completion Date
2019-12-18
Brief Summary
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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.
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Detailed Description
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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 1.5 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 2.5 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, and/or 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 2.5 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 1.5 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 2.5 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, and/or 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 2.5 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.
Conditions
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Tobacco Use Disorder
Smoking Cessation
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Bupropion
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Group Type
EXPERIMENTAL
Bupropion
Intervention Type
DRUG
Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
Smoking Cessation Counseling
Intervention Type
BEHAVIORAL
Counseling over 8 months and telephone support calls.
Varenicline
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Group Type
EXPERIMENTAL
Varenicline
Intervention Type
DRUG
Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
Smoking Cessation Counseling
Intervention Type
BEHAVIORAL
Counseling over 8 months and telephone support calls.
Placebo
Placebo by mouth for 12 weeks.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo by mouth for 12 weeks.
Smoking Cessation Counseling
Intervention Type
BEHAVIORAL
Counseling over 8 months and telephone support calls.
Interventions
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Bupropion
Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
Intervention Type
DRUG
Varenicline
Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
Intervention Type
DRUG
Placebo
Placebo by mouth for 12 weeks.
Intervention Type
DRUG
Smoking Cessation Counseling
Counseling over 8 months and telephone support calls.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Wellbutrin
Wellbutrin SR
Zyban
Chantix
Eligibility Criteria
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Inclusion Criteria
1. Age: 18-65 years old
2. Smoking: \>/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm.
3. Able to follow verbal and written instructions in English and complete all aspects of the study
4. Have an address and home telephone number where they may be reached
5. Provide informed consent and agree to all assessments and study procedures
6. Be the only participant in their household
2. Smoking: \>/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm.
3. Able to follow verbal and written instructions in English and complete all aspects of the study
4. Have an address and home telephone number where they may be reached
5. Provide informed consent and agree to all assessments and study procedures
6. Be the only participant in their household
Exclusion Criteria
1. Within the month immediately preceding the screening visit; use of any form of tobacco product other than cigarettes on 3 or more days within a week only if the individual refuses to refrain from non-cigarette tobacco use during the course of this study
2. Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week
3. Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
4. Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments
5. Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion.
6. Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline.
7. Severe renal impairment (CR Clearance \<30 ml/min/1.73 m2).
8. Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator
9. Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI for items A, B, D, I, J, K, L, M and N, including a past manic or hypomanic episode as well as a lifetime psychotic disorder.
10. Subject rated as moderate to high on suicidality as assessed by the MINI.
11. Psychiatric hospitalization within 1 year of screening date.
12. A positive urine pregnancy test during the screening period. Women who are two years post menopausal, one year post-tubal ligation, or who have had a partial or full hysterectomy will not be subject to a urine pregnancy test.
13. Pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable, effective method of birth control while enrolled in the study
14. Use of Varenicline or Bupropion within two weeks before the screening visit.
15. History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
16. Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study.
2. Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week
3. Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
4. Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments
5. Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion.
6. Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline.
7. Severe renal impairment (CR Clearance \<30 ml/min/1.73 m2).
8. Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator
9. Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI for items A, B, D, I, J, K, L, M and N, including a past manic or hypomanic episode as well as a lifetime psychotic disorder.
10. Subject rated as moderate to high on suicidality as assessed by the MINI.
11. Psychiatric hospitalization within 1 year of screening date.
12. A positive urine pregnancy test during the screening period. Women who are two years post menopausal, one year post-tubal ligation, or who have had a partial or full hysterectomy will not be subject to a urine pregnancy test.
13. Pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable, effective method of birth control while enrolled in the study
14. Use of Varenicline or Bupropion within two weeks before the screening visit.
15. History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
16. Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sponsor Role
collaborator
National Institute on Drug Abuse (NIDA)
NIH
Sponsor Role
collaborator
M.D. Anderson Cancer Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Paul Cinciripini, PhD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Site Status
Countries
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United States
References
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Cui Y, Robinson JD, Versace F, Lam CY, Minnix JA, Karam-Hage M, Dani JA, Kosten TR, Wetter DW, Brown VL, Cinciripini PM. Differential cigarette-related startle cue reactivity among light, moderate, and heavy smokers. Addict Behav. 2012 Aug;37(8):885-9. doi: 10.1016/j.addbeh.2012.02.003. Epub 2012 Feb 15.
Reference Type
BACKGROUND
Cui Y, Versace F, Engelmann JM, Minnix JA, Robinson JD, Lam CY, Karam-Hage M, Brown VL, Wetter DW, Dani JA, Kosten TR, Cinciripini PM. Alpha oscillations in response to affective and cigarette-related stimuli in smokers. Nicotine Tob Res. 2013 May;15(5):917-24. doi: 10.1093/ntr/nts209. Epub 2012 Oct 11.
Reference Type
BACKGROUND
Cui Y, Robinson JD, Engelmann JM, Lam CY, Minnix JA, Karam-Hage M, Wetter DW, Dani JA, Kosten TR, Cinciripini PM. Reinforcement sensitivity underlying treatment-seeking smokers' affect, smoking reinforcement motives, and affective responses. Psychol Addict Behav. 2015 Jun;29(2):300-311. doi: 10.1037/adb0000050. Epub 2015 Jan 26.
Reference Type
BACKGROUND
Cui Y, Engelmann JM, Xian J, Minnix JA, Lam CY, Karam-Hage M, Cinciripini PM, Robinson JD. Pharmacological intervention and abstinence in smokers undergoing cessation treatment: A psychophysiological study. Int J Psychophysiol. 2018 Jan;123:25-34. doi: 10.1016/j.ijpsycho.2017.12.001. Epub 2017 Dec 6.
Reference Type
BACKGROUND
Minnix JA, Versace F, Robinson JD, Lam CY, Engelmann JM, Cui Y, Brown VL, Cinciripini PM. The late positive potential (LPP) in response to varying types of emotional and cigarette stimuli in smokers: a content comparison. Int J Psychophysiol. 2013 Jul;89(1):18-25. doi: 10.1016/j.ijpsycho.2013.04.019. Epub 2013 May 2.
Reference Type
BACKGROUND
Robinson JD, Versace F, Lam CY, Minnix JA, Engelmann JM, Cui Y, Karam-Hage M, Shete SS, Tomlinson GE, Chen TT, Wetter DW, Green CE, Cinciripini PM. The CHRNA3 rs578776 Variant is Associated with an Intrinsic Reward Sensitivity Deficit in Smokers. Front Psychiatry. 2013 Sep 23;4:114. doi: 10.3389/fpsyt.2013.00114. eCollection 2013.
Reference Type
BACKGROUND
Versace F, Minnix JA, Robinson JD, Lam CY, Brown VL, Cinciripini PM. Brain reactivity to emotional, neutral and cigarette-related stimuli in smokers. Addict Biol. 2011 Apr;16(2):296-307. doi: 10.1111/j.1369-1600.2010.00273.x. Epub 2010 Dec 23.
Reference Type
BACKGROUND
Versace F, Lam CY, Engelmann JM, Robinson JD, Minnix JA, Brown VL, Cinciripini PM. Beyond cue reactivity: blunted brain responses to pleasant stimuli predict long-term smoking abstinence. Addict Biol. 2012 Nov;17(6):991-1000. doi: 10.1111/j.1369-1600.2011.00372.x. Epub 2011 Oct 4.
Reference Type
BACKGROUND
Versace F, Engelmann JM, Robinson JD, Jackson EF, Green CE, Lam CY, Minnix JA, Karam-Hage MA, Brown VL, Wetter DW, Cinciripini PM. Prequit fMRI responses to pleasant cues and cigarette-related cues predict smoking cessation outcome. Nicotine Tob Res. 2014 Jun;16(6):697-708. doi: 10.1093/ntr/ntt214. Epub 2013 Dec 27.
Reference Type
BACKGROUND
Meyer MJ, Coull BA, Versace F, Cinciripini P, Morris JS. Bayesian function-on-function regression for multilevel functional data. Biometrics. 2015 Sep;71(3):563-74. doi: 10.1111/biom.12299. Epub 2015 Mar 18.
Reference Type
BACKGROUND
Zhu H, Versace F, Cinciripini PM, Rausch P, Morris JS. Robust and Gaussian spatial functional regression models for analysis of event-related potentials. Neuroimage. 2018 Nov 1;181:501-512. doi: 10.1016/j.neuroimage.2018.07.006. Epub 2018 Jul 6.
Reference Type
BACKGROUND
Cinciripini PM, Green CE, Robinson JD, Karam-Hage M, Engelmann JM, Minnix JA, Wetter DW, Versace F. Benefits of varenicline vs. bupropion for smoking cessation: a Bayesian analysis of the interaction of reward sensitivity and treatment. Psychopharmacology (Berl). 2017 Jun;234(11):1769-1779. doi: 10.1007/s00213-017-4580-2. Epub 2017 Mar 8.
Reference Type
BACKGROUND
Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
Reference Type
DERIVED
Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.
Reference Type
DERIVED
Cinciripini PM, Robinson JD, Karam-Hage M, Minnix JA, Lam C, Versace F, Brown VL, Engelmann JM, Wetter DW. Effects of varenicline and bupropion sustained-release use plus intensive smoking cessation counseling on prolonged abstinence from smoking and on depression, negative affect, and other symptoms of nicotine withdrawal. JAMA Psychiatry. 2013 May;70(5):522-33. doi: 10.1001/jamapsychiatry.2013.678.
Reference Type
DERIVED
Versace F, Engelmann JM, Jackson EF, Costa VD, Robinson JD, Lam CY, Minnix JA, Brown VL, Wetter DW, Cinciripini PM. Do brain responses to emotional images and cigarette cues differ? An fMRI study in smokers. Eur J Neurosci. 2011 Dec;34(12):2054-63. doi: 10.1111/j.1460-9568.2011.07915.x. Epub 2011 Nov 20.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://www.mdanderson.org
University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2012-02108
Identifier Type: REGISTRY
Identifier Source: secondary_id
2003-1024
Identifier Type: -
Identifier Source: org_study_id
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NA
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