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

Phase 4

Completed

• Conditions: Smoking
• Interventions: Drug: Bupropion

• Registration Number: NCT00846339
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-02-14
• Study First Submitted QC: 2009-02-14
• Study First Posted: 2009-02-18
• Primary Completion: 2009-03
• Study Completion: 2009-06
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-19
• Last Update Posted: 2011-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Bupropion	DRD Taq1 A2 homozygote2
1	Bupropion	DRD2 Taq1A1 allele

Primary Outcome Measures

Name	Time	Method
Dopamine receptor occupancy	1 week

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of bupropion and hydroxybupropion	1 week

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of