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PET Imaging Study on Occupancy of Dopamine D2 Receptors and Genotypes After Bupropion Administration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846339
First Posted: February 18, 2009
Last Update Posted: February 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ministry of Health, Welfare and Family Affairs
Korea National Enterprise for Clinical Trials
Information provided by:
Seoul National University Hospital
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters of bupropion and hydroxybupropion [ Time Frame: 1 week ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kyung-Sang Yu, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00846339     History of Changes
Other Study ID Numbers: SNUCPT08_BUP1
First Submitted: February 14, 2009
First Posted: February 18, 2009
Last Update Posted: February 23, 2011
Last Verified: February 2011

Keywords provided by Seoul National University Hospital:
Smoking cessation
Bupropion

Additional relevant MeSH terms:
Bupropion
Dopamine
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Protective Agents