Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers

Completed

• Conditions: Nicotine Dependence
• Interventions: Drug: Amphetamine

• Registration Number: NCT02348385
• Lead Sponsor: Yale University

Brief Summary

The goal is to examine sex differences in amphetamine-induced dopamine release in tobacco smokers and nonsmokers.

Detailed Description

Aim 1:

To determine sex differences in amphetamine-induced dopamine (DA) release in healthy tobacco smokers and nonsmokers.

FLB-457 has been used in several PET centers and has recently been approved for use at the Yale University PET Center. We would like to determine whether there are sex differences in amphetamine induced DA release in healthy tobacco smokers and nonsmokers. Specifically, 40 healthy tobacco smokers and 40 healthy nonsmokers will have an magnetic resonance imaging (MRI) scan followed on another day by two FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered.

Aim 2:

To determine sex differences in amphetamine-induced dopamine release in tobacco smokers from Aim 1 after treatment with guanfacine. Guanfacine will be given under a different protocol. We plan to determine whether guanfacine treatment differentially inhibits amphetamine-induced DA release in men and smokers from Aim 1. After their first scan, the same 40 healthy tobacco smokers from Aim 1 will take guanfacine for 3 weeks under and then will have another set of FLB scans (ideally, the two PET scans will be carried out in the same day). Starting at 3 hours before the second PET scan, amphetamine (0.4mg/kg, PO) will be administered, as before. The sets of scans will be separated by at least 21 days, but due to scheduling and technical difficulties the second set may be scheduled up to 6 weeks after the first set.

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2020-01-22
• Results First Submitted QC: 2020-03-11
• Results First Posted: 2020-03-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Tobacco Smokers	Amphetamine	There is only one arm to the study. All subjects will receive amphetamine
Healthy Nonsmokers	Amphetamine	There is only one arm to the study. All subjects will receive amphetamine

Primary Outcome Measures

Name	Time	Method
Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration	After 2 PET Scans (1 day)	Percent change in binding potential of dopamine release during PET scan post amphetamine administration.Binding potential (BP) is the PET neuroimaging outcome measure that is computed as a proxy for availability of dopamine D2/3 receptors in a given region-of-interest.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States