Imaging Extrastriatal Dopamine Release in Tobacco Smokers and Nonsmokers

NCT02348385 | Completed Results DMC

• 2 other identifiers: 11060086781K02DA031750-01A1
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nicotine Dependence

Keywords

amphetamine; cigarette smokers

Outcome Measures

Primary Outcomes (1)

• Percent Change in Binding Potential of Dopamine Release During PET Scan Post Amphetamine Administration

  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.

  After 2 PET Scans (1 day)

Study Arms (2)

Healthy Tobacco Smokers

There is only one arm to the study. All subjects will receive amphetamine

Drug: Amphetamine

Healthy Nonsmokers

There is only one arm to the study. All subjects will receive amphetamine

Drug: Amphetamine

Interventions

Amphetamine DRUG

Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.

Also known as: dextroamphetamine

Healthy Nonsmokers; Healthy Tobacco Smokers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy Smokers and non smokers

You may qualify if:

• men and women, aged 18-55 years
• who are able to read and write
• who are able to give voluntary written informed consent
• have no current uncontrolled medical condition such as neurological, cardiovascular, endocrine, renal, liver, or thyroid pathology
• have no history of a neurological or psychiatric disorder, e.g., no DSM-IV Axis 1 diagnosis in 2 preceding years)
• drink less than 21 drinks/week for women and less than 35 drinks per week for men
• have not used marijuana in the past 30 days and have not met criteria for dependence in the past 2 years
• do not suffer from claustrophobia or any MRI contradictions
• to participate in imaging studies including 2 PET scans and 1 MRI scan
• nonsmokers (smoked \< 100 cigarettes in lifetime with urinary cotinine levels 0-30 ng/mL both at intake evaluation and on scan day)
• smokers (smoked at least 10 cigarettes/day for at least one year with an Fagerstrom score (FTND)\>3, urine cotinine \>150 ng/mL and carbon monoxide (CO) \>12 ppm at intake)

You may not qualify if:

• psychosis
• presence of acute or unstable medical or neurological illness. Subjects will be excluded from the study if they present with any history of serious medical or neurological illness or if they show signs of a major medical or neurological illness on examination or lab testing including history of seizures, head injury, brain tumor, heart, liver or kidney disease, eating disorder, diabetes.
• regular use of any psychotropic drugs including anxiolytics and antidepressants and other over-the-counter medications and herbal products within the last six months
• pregnancy/Breast feeding (as documented by pregnancy testing at screening or at days of the imaging studies),
• suicidal ideation or behavior
• pacemaker or other ferromagnetic material in body.
• use of medications which affect dopamine transmission within 2 weeks of the PET study
• Participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits for normal volunteers.
• Blood donation within 8 weeks of the start of the study.
• history of a bleeding disorder or are taking medication to thin their blood

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will be obtained for hormones and amphetamine drug levels

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Amphetamine; Dextroamphetamine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Kelly Cosgrove
• Organization: Yale

kelly.cosgrove@yale.edu

203-737-6969

Study Officials

• Kelly Cosgrove, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 28, 2015
• Study Start: December 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 2, 2023
• Results First Posted: March 18, 2020

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)