NCT02921282

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

3.3 years

First QC Date

September 22, 2016

Last Update Submit

March 6, 2024

Conditions

Cigarette Smoking Behavior

Keywords

genescuesrewardsmoking

Outcome Measures

Primary Outcomes (1)

  • Number of puffs on a cigarette

    Puffs taken from either a nicotinized or a denicotinized cigarette

    3 years

Secondary Outcomes (2)

  • Craving in response to nicotine cues

    3 years

  • Physiological measures in response to cues

    3 years

Study Arms (2)

Genotype dopamine

Genotyping will be conducted at the conclusion of the study

Genetic: Genotype dopamineGenetic: Genotype cannabinoids

Genotype cannabinoids

Genotyping will be conducted at the conclusion of the study

Genetic: Genotype dopamineGenetic: Genotype cannabinoids

Interventions

Genotype dopamineGENETIC

Laboratory investigations of nicotine reinforcement

Genotype cannabinoidsGenotype dopamine
Genotype cannabinoidsGENETIC

Laboratory investigations of nicotine reinforcement

Genotype cannabinoidsGenotype dopamine

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Otherwise healthy smokers will be recruited

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 1S8, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected

MeSH Terms

Conditions

Cigarette SmokingSmoking

Condition Hierarchy (Ancestors)

Tobacco SmokingBehaviorTobacco Use

Study Officials

  • Bernard Le Foll, MD PhD

    CAMH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist

Study Record Dates

First Submitted

September 22, 2016

First Posted

October 3, 2016

Study Start

August 1, 2016

Primary Completion

November 29, 2019

Study Completion

November 29, 2019

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)