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

Primary Outcome Measures:

  • Number of puffs on a cigarette [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

  • 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:

  1. 19-64 year old males and females
  2. smoking at least 10 cigarettes per day for at least 1 year
  3. urinary cotinine level ≥ 100 ng/ml (NicAlert® reading ≥ 3)
  4. medically and psychologically healthy as determined by screening criteria

Exclusion Criteria:

  1. definite plan to reduce or quit tobacco use in the next 30 days
  2. treatment for tobacco dependence in the past 3 months
  3. use of nicotine replacement products, bupropion, or varenicline in the past 3 months
  4. consumption of more than 15 alcoholic drinks per week during the past month
  5. use of any illicit drug more than twice per week during the past month
  6. current use of any medication that would interfere with the protocol in the opinion of PI
  7. under the influence of a drug or alcohol at any session
  8. pregnant, nursing, or become pregnant during the study

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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