Test-retest Reproducibility of [11C]PHNO PET Using the Constant Infusion Paradigm

NCT01699607 | Completed Results

• 3 other identifiers: 0910005822R25MH0715841P50CA196530-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A research study designed to examine amphetamine-induced dopamine release using the PET imaging agent \[11C\]PHNO in tobacco smokers while currently smoking and during acute withdrawal and in nonsmokers. Twenty healthy men and women tobacco smokers and twenty healthy nonsmokers will be recruited. Each subject will participate in 1 MRI and up to 2 \[11C\]PHNO PET scans. On the study day subjects will participate in two \[11C\]PHNO scans (ideally, the two PET scans will be carried out in the same day). Three hours before the second PET scan, amphetamine (0.5 mg/kg, PO) will be administered. In smokers, the scan will occur at 10-21 days of smoking abstinence.

Conditions

Nicotine Dependence; Healthy

Keywords

Cigarette Smokers; Healthy Non Smokers; Amphetamine; PET; Controls

Outcome Measures

Primary Outcomes (1)

• Change in Dopamine Levels at Baseline and After Amphetamine Administration as Measured by Percent Change in PET Tracer Binding Potential.

  PET images will be obtained in subjects at baseline and after amphetamine administration. Dopamine release will be measured as a percent change in binding potential. Increased dopamine release will result in decreased radiotracer binding because dopamine will displace the radiotracer.

  first 90 minute scan at baseline, second 90 minute scan start 150 minutes post amphetamine administration

Study Arms (1)

amphetamine

EXPERIMENTAL

There is only one arm to the study. All subjects will receive amphetamine at 0.5mg/kg prior to the second PET scan.

Drug: Amphetamine

Interventions

Amphetamine DRUG

All subjects will receive amphetamine to induce elevated dopamine levels in the brain at 0.5mg/kg

Also known as: dextro-amphetamine

amphetamine

Eligibility Criteria

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

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 DSMIV Axis 1 diagnosis in 2 preceding years, except nicotine dependence in smokers)
• 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
• nonsmokers (smoked \< 40 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 FTND\>3, urine cotinine \>150 ng/mL and 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 on 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

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

Limitations and Caveats

Preliminary data. Small subject number.

Results Point of Contact

• Title: Dr. Kelly Cosgrove, Ph.D.
• Organization: Yale

kelly.cosgrove@yale.edu

203-737-6969

Study Officials

• Kelly Cosgrove, Ph.D.

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: June 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 6, 2020
• Results First Posted: September 18, 2015

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)