NCT00396669

Brief Summary

Dopamine (DA) plays a critical role in nicotine (and other) addiction and this drug is known to release DA in brain areas mediating reward and motivational processes. Although imaging studies show that release of DA follows smoking, little is known regarding how common genetic polymorphisms for three genes associated in some studies with smoking (dopamine D2 receptor, dopamine and serotonin transporter) interact with smoking status and modulate individual differences in nicotine-induced DA release and dopamine receptor occupancy, in vivo. The current proposal combines brain imaging and genomics ('imaging genomics') towards partially unraveling the complex relationship between smoking phenotype and common polymorphisms. Understanding whether genetic factors contribute to inter-individual variability in smoking is crucial for interpreting imaging results in the context of disease pathology. We hypothesize that a model of vulnerability to addiction based on interactions between genotype, receptor and transporter availability and in vivo nicotine-induced DA release will elucidate some of the fundamental neurochemical and neurogenetic circuits underlying addiction.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 27, 2012

Status Verified

March 1, 2012

Enrollment Period

5 years

First QC Date

November 6, 2006

Last Update Submit

March 26, 2012

Conditions

Keywords

NicotineDopamineImagingRacloprideAddictionGenetics

Outcome Measures

Primary Outcomes (1)

  • Dopamine D2 receptor occupancy before and after smoking a cigarette with nicotine

    30 minutes

Secondary Outcomes (1)

  • Subjective measures of craving, anxiety and depression.

    30 minutes

Study Arms (1)

Dopamine release

EXPERIMENTAL
Drug: Bupropion

Interventions

We measure dopamine release at the striatum using 11 C Raclopride at baseline and after smoking a cigarette

Dopamine release

Eligibility Criteria

Age21 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • smokers who smoked 15 cigarettes/day and who met the DSM-IV criteria for nicotine dependence

You may not qualify if:

  • Subjects who are diagnosed as suffering from psychotic illness according to DSM-IV (Axis 1)22, or with a history of CNS disease, a history of infection that might affect CNS (HIV, syphilis, cytomegalovirus, herpes), or a history of head injury with loss of consciousness will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Tobacco Use DisorderBehavior, Addictive

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Aviv M Weinstein, Ph.D

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR
  • Moshe Bocher, M.D

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aviv M Weinstein, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

November 6, 2006

First Posted

November 7, 2006

Study Start

July 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 27, 2012

Record last verified: 2012-03

Locations