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

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

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

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dopamine receptor occupancy	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters of bupropion and hydroxybupropion	1 week

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: 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 record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: February 14, 2009
• First Submitted That Met QC Criteria: February 14, 2009
• First Posted (Estimate): February 18, 2009

Study Record Updates

• Last Update Posted (Estimate): February 23, 2011
• Last Update Submitted That Met QC Criteria: February 19, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Smoking cessation; Bupropion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: SNUCPT08_BUP1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No