Verified September 2016 by Centre for Addiction and Mental Health
Sponsor:
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT02921282
First received: September 22, 2016
Last updated: September 29, 2016
Last verified: September 2016
In this study, potential associations between several genetic polymorphisms and nicotine dependence will be examined. The relative reinforcing efficacy of cigarettes using the forced-choice procedure will be assessed. In addition, eactivity to smoking cues using a reliable procedure will be conducted.
Cigarette Smoking Behavior | Genetic: Genotype dopamine Genetic: Genotype cannabinoids |
Study Type: | Observational |
Study Design: | Time Perspective: Prospective |
Official Title: | Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms |
- Number of puffs on a cigarette [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Craving in response to nicotine cues [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Physiological measures in response to cues [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood samples will be collected
Estimated Enrollment: | 30 |
Study Start Date: | August 2016 |
Estimated Study Completion Date: | August 2017 |
Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
Genotype dopamine
Genotyping will be conducted at the conclusion of the study |
Genetic: Genotype dopamine
Laboratory investigations of nicotine reinforcement Genetic: Genotype cannabinoids Laboratory investigations of nicotine reinforcement |
Genotype cannabinoids
Genotyping will be conducted at the conclusion of the study |
Genetic: Genotype dopamine
Laboratory investigations of nicotine reinforcement Genetic: Genotype cannabinoids Laboratory investigations of nicotine reinforcement |
It is known that cannabinoid and dopamine receptors can be important modulators of response to nicotine and its associated cues. In this study participants will be genotyped to determine whether there is a relationship between CB1 or D3 genes and the reinforcing properties of nicotine or the subjective effects of nicotine-associated cues. In one session, participants will chose between two different cigarettes, each with different properties. In another session, physiological responses and craving will be measured when presented with cues that remind participants of nicotine. At some point during the study, blood will be collected for genotyping and this will processed to study whether CB1 or D3 genotype influences these responses to nicotine or cues.
Ages Eligible for Study: | 19 Years to 64 Years (Adult) |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Otherwise healthy smokers will be recruited
Inclusion Criteria:
- 19-64 year old males and females
- smoking at least 10 cigarettes per day for at least 1 year
- urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
- medically and psychologically healthy as determined by screening criteria
Exclusion Criteria:
- definite plan to reduce or quit tobacco use in the next 30 days
- treatment for tobacco dependence in the past 3 months
- use of nicotine replacement products, bupropion, or varenicline in the past 3 months
- consumption of more than 15 alcoholic drinks per week during the past month
- use of any illicit drug more than twice per week during the past month
- current use of any medication that would interfere with the protocol in the opinion of PI
- under the influence of a drug or alcohol at any session
- pregnant, nursing, or become pregnant during the study
Please refer to this study by its ClinicalTrials.gov identifier: NCT02921282
Centre for Addiction and Mental Health | |
Toronto, Ontario, Canada, M5S 1S8 | |
Contact: Patricia DiCiano, PhD 416-535-8501 ext 34002 Patricia.DiCiano@nullcamh.ca | |
Contact: Chidera Chukwueke, BSc 416-535-8501 chidera.chukwueke@nullcamh.ca | |
Principal Investigator: Bernard Le Foll, MD, PhD |
Centre for Addiction and Mental Health
Principal Investigator: | Bernard Le Foll, MD PhD | CAMH |
Responsible Party: | Bernard Le Foll, Scientist, Centre for Addiction and Mental Health |
ClinicalTrials.gov Identifier: | NCT02921282 History of Changes |
Other Study ID Numbers: | 134-2015 |
Study First Received: | September 22, 2016 |
Last Updated: | September 29, 2016 |
Health Authority: | Canada: Health Canada |
Individual Participant Data | |
Plan to Share IPD: | Yes |
Plan Description: | Data will be shared with collaborators at NIDA-IRP |
Keywords provided by Centre for Addiction and Mental Health:
genes cues reward smoking |
Additional relevant MeSH terms:
Nicotine Dopamine Dopamine Agents Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Agonists |
Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Sympathomimetics Protective Agents |
ClinicalTrials.gov processed this record on October 03, 2016