PET Imaging Study on Occupancy of Dopamine D2 Receptors and Genotypes After Bupropion Administration
This study has been completed.
Sponsor:
Seoul National University Hospital
Collaborators:
Ministry of Health, Welfare and Family Affairs
Korea National Enterprise for Clinical Trials
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00846339
First received: February 14, 2009
Last updated: February 19, 2011
Last verified: February 2011
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Purpose
Detailed Description:
Bupropion has different effects on D2 dopamine receptors according to genotype.
Condition | Intervention | Phase |
---|---|---|
Smoking |
Drug: Bupropion |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | [11C] Raclopride PET Imaging Study That Investigates Relation Between Occupancy of Dopamine D2 Receptors and Genotypes of DRD2 After Bupropion Administration |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Dopamine receptor occupancy [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pharmacokinetic parameters of bupropion and hydroxybupropion [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Enrollment: | 12 |
Study Start Date: | November 2008 |
Study Completion Date: | June 2009 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: 1
DRD2 Taq1A1 allele
|
Drug: Bupropion
bupropion
|
Experimental: 2
DRD Taq1 A2 homozygote2
|
Drug: Bupropion
bupropion
|
Detailed Description:
Open, one arm, single sequence, 2-period, study stratified into 2 DRD2 genotype groups For subjects who volunteer to cease smoking, genotypes are investigated. Twelve subjects are enrolled (6 - DRD2 Taq1A1 allele, 6 - DRD2 Taq1A2 homozygotes). Subjects receive baseline raclopride PET (High Specific Activity, Low Specific Activity).
- Period 1 Subjects receive 150 mg of bupropion SR every day. After 1 week of medication, pharmacokinetic and PET studies are performed.
- Period 2 Subjects receive 150 mg of bupropion SR twice a day. After 1 week of medication, pharmacokinetic and PET studies are performed.
Eligibility
Ages Eligible for Study: | 20 Years to 50 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Active smoker (more than 10 cigarettes per day for the past 2 years)
Exclusion Criteria:
- Medical or psychiatric co-morbidity
- Hypersensitive to bupropion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846339
Locations
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 110-744 |
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health, Welfare and Family Affairs
Korea National Enterprise for Clinical Trials
Investigators
Principal Investigator: | Kyung-Sang Yu, MD | Seoul National Univeristy Hospital |
More Information
No publications provided
Keywords provided by Seoul National University Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 26, 2012
No publications provided
Responsible Party: | Kyung-Sang Yu, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00846339 History of Changes |
Other Study ID Numbers: | SNUCPT08_BUP1 |
Study First Received: | February 14, 2009 |
Last Updated: | February 19, 2011 |
Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Seoul National University Hospital:
Smoking cessation Bupropion |
Additional relevant MeSH terms:
Smoking Habits Dopamine Bupropion Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on September 26, 2012