Smoking-induced Dopamine Release: a [11C]-(+)-PHNO PET Study in Humans
This study has been completed.
Sponsor:
Centre for Addiction and Mental Health
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01302262
First received: February 22, 2011
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
This study will evaluate effects of smoking on the dopaminergic system by using PET tomography with new radioligand, [11C]-(+)-PHNO. Our primary hypothesis is that smoking a cigarette will produce dopamine release and this release can be measured using PET imaging and the [11C]-(+)-PHNO radiotracer. The secondary hypothesis is that this smoking induced dopamine release will be correlated with subjective craving and anxiety ratings.
| Condition |
|---|
|
Tobacco Use Disorder |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Does the Insula Control Smoking-induced Dopamine Release? A TMS/[11C]-PHNO Study in Humans. Part I: Smoking-induced Dopamine Release: a [11C]-(+)-PHNO PET Study in Humans. |
Resource links provided by NLM:
Further study details as provided by Centre for Addiction and Mental Health:
Primary Outcome Measures:
- [11C]-(+)-PHNO binding potential [ Time Frame: Up to 14 days between PET scans ] [ Designated as safety issue: No ]The process of imaging requires the injection of a positron-emitting radiotracer (here, [11C]-(+)-PHNO) that binds to the protein of interest (here, dopamine receptor DRD2/3) followed by the measurement of this binding using the PET scanner. Dopamine release increases DRD 2/3 occcupancy which results in decreased radiotracer's binding potential, and vice versa. [11C]-(+)-PHNO binding potential will be measured on two different conditions (Smoking vs. Non-smoking) on two separate days.
Secondary Outcome Measures:
- Subjective reports of craving [ Time Frame: Up to 14 days between PET scans ] [ Designated as safety issue: No ]Levels of subjective craving will be assessed prior to and after each condition (Smoking vs. Non-smoking) on two separate days. Minnesota Nicotine Withdrawal Scale, Tiffany Questionnaire of Smoking Urges, The Urge to Smoke scale, Tobacco Craving Questionnaire, and 21-item Visual Analogue Scale will be used.
- Subjective reports of anxiety [ Time Frame: Up to 14 days between PET scans ] [ Designated as safety issue: No ]Subjective reports of anxiety will be collected prior to and after each condition (Smoking vs. Non-smoking) on two separate days. State anxiety questions from the Spielberg State-Trait Anxiety Inventory will be used.
Biospecimen Retention: Samples With DNA
Whole blood (15mL)
| Enrollment: | 10 |
| Study Start Date: | February 2011 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Healthy smokers
Healthy male and female smokers. Each subject will undergo PET scan (along with craving and anxiety questionnaires) on two conditions - Smoking and Non-smoking - on two separate visits.
|
Detailed Description:
This will be a within-subjects study in healthy male and female smokers. There will be one within factor condition: Smoking and Non Smoking. Therefore, there will be a repeated measure of PET scans using [11C]-(+)-PHNO under two different conditions. Ten subjects (n=5 male and n=5 female) included in the study will come on two different days and will have a Smoking or Non smoking session performed just before the PET study. Subjective assessments will be conducted at each experimental condition.
Eligibility| Ages Eligible for Study: | 21 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Healthy smokers
Criteria
Inclusion Criteria:
- Adult males or females
- Regular smoking of at least 10 cigarettes, excluding ultra-low nicotine cigarettes, per day for at least two years
- Score on the Fagerstrom Test for Nicotine Dependence of 4 or more
- No intention to quit or reduce tobacco use, and no treatment for tobacco dependence currently
- No history of abuse of or dependence on any other drug, defined by DSM-IV criteria
Exclusion Criteria:
- Pregnancy
- Presence of metal objects in the body or implanted electronic devices, that preclude safe MR scanning
- Claustrophobia
- Cardiovascular or cerebrovascular diseases
- Major psychiatric disorders including mood, anxiety or psychotic disorders
- History of or current neurological illnesses including seizure disorders, migraine, multiple sclerosis, movement disorders, head trauma, CVA or CNS tumor
- Gross structural brain abnormalities as revealed by T1 weighted images
- Current use or use during the previous month of medication that may affect the CNS (e.g. neuroleptics, bupropion)
- Learning disability, amnesia or other conditions that impede memory and attention
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302262
Locations
| Canada, Ontario | |
| Centre for Addiction and Mental Health - 33 Russell St | |
| Toronto, Ontario, Canada, M5S 2S1 | |
Sponsors and Collaborators
Centre for Addiction and Mental Health
Pfizer
Investigators
| Principal Investigator: | Bernard Le Foll, MD | Centre for Addiction and Mental Health |
More Information
Additional Information:
Publications:
| Responsible Party: | Bernard Le Foll, MD, PhD, CCFP, Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT01302262 History of Changes |
| Other Study ID Numbers: | 143/2010 |
| Study First Received: | February 22, 2011 |
| Last Updated: | March 4, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Centre for Addiction and Mental Health:
|
Smoking-induced dopamine release [11C]-(+)-PHNO PET Study |
Additional relevant MeSH terms:
|
Smoking Tobacco Use Disorder Habits Substance-Related Disorders Mental Disorders Dopamine Dopamine Agents Cardiotonic Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013