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
• 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

• Smoking

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