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NCT00846339 Clinical Trial

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

Smoking Clinical Trial

Official title:
[11C] Raclopride PET Imaging Study That Investigates Relation Between Occupancy of Dopamine D2 Receptors and Genotypes of DRD2 After Bupropion Administration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00846339
Other study ID # SNUCPT08_BUP1
Secondary ID
Status Completed
Phase Phase 4
First received February 14, 2009
Last updated February 19, 2011
Start date November 2008
Est. completion date June 2009

Study information
Verified date February 2011
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Bupropion has different effects on D2 dopamine receptors according to genotype.

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date June 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Male
Age group 20 Years to 50 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bupropion
bupropion

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (3)
Lead Sponsor Collaborator
Seoul National University Hospital Korea National Enterprise for Clinical Trials, Ministry of Health, Welfare and Family Affairs

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dopamine receptor occupancy 1 week No
Secondary Pharmacokinetic parameters of bupropion and hydroxybupropion 1 week No
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