Cigarette Smoking BehaviorNCT02921282
Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms
An observational study of Cigarette Smoking Behavior, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking Behavior
- What is being tested?
- Genotype dopamine and Genotype cannabinoids
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to 29 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Otherwise healthy smokers will be recruited
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Cigarette Smoking Behavior
- Being tested
- Genotype dopamine, Genotype cannabinoids
- Keywords
- genes, cues, reward, smoking
- Medical subject headings
- Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genotype dopamineGenetic
Laboratory investigations of nicotine reinforcement
Genotype cannabinoidsGenetic
Laboratory investigations of nicotine reinforcement
| Study group | Role | What they receive |
|---|---|---|
| Genotype dopamine | Genotyping will be conducted at the conclusion of the study Receives: Genetic: Genotype dopamine; Genetic: Genotype cannabinoids | |
| Genotype cannabinoids | Genotyping will be conducted at the conclusion of the study Receives: Genetic: Genotype dopamine; Genetic: Genotype cannabinoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of puffs on a cigarette
Puffs taken from either a nicotinized or a denicotinized cigarette
Measured: 3 years
Secondary outcomes (2)
Craving in response to nicotine cues
Craving scores measured by questionnaires in response to either smoking-related or neutral cues
Measured: 3 years
Physiological measures in response to cues
Physiological measures (eg., heart rate and/or blood pressure) in response to smoking-related or neutral cues
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startAug 2016
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking BehaviorStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernard Le Foll, Centre for Addiction and Mental Health
- Investigators
- Bernard Le Foll, MD PhD, Principal investigator, CAMH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921282
- Sponsor's protocol ID
- 134-2015
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2016
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms
- ClinicalTrials.gov ID
- NCT02921282
- Acronym / sponsor ID
- 134-2015
- Conditions
- Cigarette Smoking Behavior
- Keywords
- genes, cues, reward, smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype dopamine | – | Genetic: Genotype dopamine, Genetic: Genotype cannabinoidsGenotyping will be conducted at the conclusion of the study |
| Genotype cannabinoids | – | Genetic: Genotype dopamine, Genetic: Genotype cannabinoidsGenotyping will be conducted at the conclusion of the study |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Otherwise healthy smokers will be recruited
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genotype dopamineLaboratory investigations of nicotine reinforcement | Genetic | Genotype cannabinoids, Genotype dopamine |
| Genotype cannabinoidsLaboratory investigations of nicotine reinforcement | Genetic | Genotype cannabinoids, Genotype dopamine |
Primary outcome
Number of puffs on a cigarette
Time frame: 3 years
Puffs taken from either a nicotinized or a denicotinized cigarette
2 secondary outcomes
Craving in response to nicotine cues
Time frame: 3 years
Physiological measures in response to cues
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Le Foll, MD PhD principal investigator
CAMH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cigarette Smoking Behavior, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puffs on a cigarette (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.