The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
NCT01632189
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Subjects will be nicotine dependent, males and females of any ethnic origin between 21 and 45 years old.
- Meet DSM-IV criteria for nicotine dependence,
- Smoke ≥10 cigarettes/day, Baseline FTND score ≥4, CO level ≥10 and are motivated to quit within 30 days of initial intake.
- Treatment seeking smokers that are willing to use varenicline as a treatment approach for their smoking cessation attempt
- No previous use of medication for smoking cessation in previous month prior inclusion.
- Pregnancy (a urine pregnancy test will be performed before each PET in women)
- Trying to become pregnant or breastfeeding;
- Have abused alcohol or other drugs of abuse (cocaine, opiates, benzodiazepines, etc)
in 3 months prior to randomization.
- Presence of metal objects in the body (e.g. some artificial joints, bone pins,
surgical clips, skull plate, certain part of dental braces) or implanted electronic
devices (e.g. cardiac pacemaker, neurostimulator), that preclude safe MR scanning.
- Claustrophobia.
- Cardiovascular or cerebrovascular diseases.
- Major psychiatric disorders including mood, anxiety or psychotic disorders with
historical evidence of suicidal or homicidal behaviour.
- 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 at
the time of scanning (including illicit and non-illicit psychoactive drugs).
- Learning disability, amnesia or other conditions that impede memory and attention.
- Allergy to varenicline.
- Renal insufficiency.
- Use of other smoking cessation aids
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | The Effect of Varenicline on D2/D3 Receptor Binding in Smokers | |||
| Official Title ICMJE | Investigating the Effects of Varenicline on D2/3 Receptor Binding in Brain of Tobacco-smokers: a PET/[11C](+)PHNO Study | |||
| Brief Summary | This study will evaluate effects of treatment with varenicline, a smoking cessation drug, on the dopaminergic system by using Positron Emission Tomography (PET) imaging with new radioligand, [11C]-(+)-PHNO. The investigators primary hypothesis is that chronic varenicline administration will increase dopamine (DA) receptors levels ([11C](+)PHNO) within the human brain. | |||
| Detailed Description | Subjects will undergo a pre-treatment PET and MRI scans for baseline [11C](+)PHNO measures on Day 1. Subjects will subsequently be provided an initial 2-week supply of study medications (varenicline) and directions for use. Any adverse events, compliance to medication and smoking patterns will be noted during these two weeks. Varenicline will be used at the same dosage regimen as used for smoking cessation. After subjects go through a post-treatment PET and MRI scans on Day 10, they will be instructed to set up a quit date. There will then be follow-up visits every 2 weeks for the duration of the medication phase (3 months total) and a visit at 6 months follow-up. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Not Applicable | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Nicotine Dependence | |||
| Intervention ICMJE | Drug: Varenicline
Varenicline will be administered as prescribed: 0.5 mg for the first 3 days then 1 mg for the next 7 days and 2 mg after that. A quit date will be chosen at 11 days after starting Varenicline. Varenicline will be given for 3 months. Other Name: Champix | |||
| Study Arms ICMJE | Experimental: Varenicline
Varenicline will be used at the same dosage regimen as used for smoking cessation, i.e. 0.5mg once daily for days 1-3, 0.5mg twice daily for days 4-7 followed by 1mg twice daily. The total duration of Varenicline treatment will be three months. Intervention: Drug: Varenicline | |||
| Publications * | Di Ciano P, Guranda M, Lagzdins D, Tyndale RF, Gamaleddin I, Selby P, Boileau I, Le Foll B. Varenicline-Induced Elevation of Dopamine in Smokers: A Preliminary [(11)C]-(+)-PHNO PET Study. Neuropsychopharmacology. 2016 May;41(6):1513-20. doi: 10.1038/npp.2015.305. Epub 2015 Oct 7. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 8 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | August 2015 | |||
| Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 21 Years to 45 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01632189 | |||
| Other Study ID Numbers ICMJE | 040/2012 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Bernard Le Foll, Centre for Addiction and Mental Health | |||
| Study Sponsor ICMJE | Centre for Addiction and Mental Health | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Centre for Addiction and Mental Health | |||
| Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||