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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00846339
• Collaborator: Ministry of Health, Welfare and Family Affairs (Other), Korea National Enterprise for Clinical Trials (Other)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Smoking	Drug: Bupropion	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• 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
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 DRD2 Taq1A1 allele	Drug: Bupropion; bupropion
Experimental: 2 DRD Taq1 A2 homozygote2	Drug: Bupropion; bupropion

Outcome Measures

Primary Outcome Measures

1. Dopamine receptor occupancy [1 week]

Secondary Outcome Measures

1. Pharmacokinetic parameters of bupropion and hydroxybupropion [1 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00846339
• Other Study ID Numbers: SNUCPT08_BUP1
• First Posted: Feb 18, 2009
• Last Update Posted: Feb 23, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Smoking cessation; Bupropion
• Additional relevant MeSH terms: Bupropion

Study Results

No Results Posted as of Feb 23, 2011