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Completed

NCT Number: NCT02921282

Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms

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, reactivity to smoking cues using a reliable procedure will be conducted.

Completed

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Key information

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 1S8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 19-64 year old males and females
  • smoking at least 10 cigarettes per day for at least 1 year
  • positive urinary cotinine
  • medically and psychologically healthy as determined by screening criteria

Exclusion criteria

  • definite plan to reduce or quit tobacco use during the course of the study
  • 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

Treatment and study plan

Genotype dopamine

Genetic

Laboratory investigations of nicotine reinforcement

Genotype cannabinoids

Genetic

Laboratory investigations of nicotine reinforcement

Primary outcomes

  1. Number of puffs on a cigarette

    Time frame: 3 years

    Puffs taken from either a nicotinized or a denicotinized cigarette

Secondary outcomes

  1. Craving in response to nicotine cues

    Time frame: 3 years

    Craving scores measured by questionnaires in response to either smoking-related or neutral cues

  2. Physiological measures in response to cues

    Time frame: 3 years

    Physiological measures (eg., heart rate and/or blood pressure) in response to smoking-related or neutral cues

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2016
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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