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

This study has been completed.
Sponsor:
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
  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
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
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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

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:
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014