Nicotine DependenceNCT01505725
Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Background: Researchers have been studying behavioral components of nicotine addiction by looking at how drugs have a reinforcing effect, connecting the stimulation provided by the drug (nicotine) to the behavior that produces it (smoking). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Nicotine Dependence
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2010to 29 Nov 2013
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-64 year old males and females
- smoking at least 10 cigarettes per day for at least 1 year
- urinary cotinine level greater than or equal to 100 ng/ml (NicAlert reading greater than or equal to 3)
- medically and psychologically healthy as determined by screening criteria
Who cannot join
- 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 MAI
- under the influence of a drug or alcohol at experimental sessions
- pregnant, nursing, or become pregnant during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, 21224
About this study
Background:
- Researchers have been studying behavioral components of nicotine addiction by looking at how drugs have a reinforcing effect, connecting the stimulation provided by the drug (nicotine) to the behavior that produces it (smoking). Based on previous studies, researchers are interested in learning more about how nicotine affects current smokers' responses to psychological tests and smoking-related cues, and in studying whether certain kinds of genetic background may affect smokers' responses to these kinds of studies.
Read more
Objectives:
- To compare the effect of nicotine versus denicotinized cigarettes during specific psychological tests.
- To compare the effects of smoking cues versus neutral cues on craving, mood, and autonomic response.
- To study the effect of genes on nicotine reinforcement and smoking-cue reactivity.
Eligibility:
- Individuals between 18 and 64 years of age who are current smokers (at least 10 cigarettes per day for at least 1 year) and are not currently interested in reducing their smoking or seeking treatment for tobacco dependence.
Design:
- Pilot session:
- Participants will practice smoking using the measuring equipment that will be used in the study.
- After successful practice, participants will read or listen to music for 1 hour, during which they are not allowed to smoke.
- After the 1-hour period, participants will sample study cigarettes that have different levels of nicotine, and will be asked to guess whether the cigarettes are normal study cigarettes or denicotinized cigarettes.
- Baseline session:
- Blood, urine, and breath samples will be taken at the start of the session.
- Participants will smoke part of an initial cigarette, and then will read or listen to music for 1 hour, during which they are not allowed to smoke.
- After the 1-hour period, participants will give another breath sample and will complete questionnaires about mood and concentration levels.
- Trial sessions:
- Participants will smoke study cigarettes, and will be asked to either respond to questions about perceived nicotine levels in the cigarettes or press a lever for the chance to be rewarded with additional puffs of the cigarette. After the session, participants will give another breath sample and will complete questionnaires about mood and concentration levels.
- Participants will also participate in cue-reactivity sessions to test the body's physiological response to smoking cues (a pack of cigarettes) and neutral cues (a pack of unsharpened pencils). After the session, participants will complete questionnaires on mood and concentration 15, 30, 45, and 60 minutes after the session.
- At the conclusion of the last experimental session, participants will discuss the study with researchers, and may receive a referral list of smoking treatment programs.
Read the detailed description
Objectives: 1) to compare the reinforcing efficacy of nicotine versus denicotinized cigarettes using a forced choice and an operant response procedure, 2) to compare the effects of smoking cues versus neutral cues on craving, mood, and autonomic responsivity, and 3) to explore potential associations between several genetic polymorphisms and the phenotypic measures of nicotine reinforcement and smoking-cue reactivity.
Study population: 175 adult smokers (35 for pilot study I, 60 for pilot stufy II and 80 for main study).
Design: Placebo-controlled, within-subjects design. Pilot studies will entail 1-2 sessions. Main study will entail one baseline/adaptation session and 5-10 experimental sessions.
Outcome Measures:
Behavioral Measures
During forced-choice sessions, primary measure is the percentage of nicotine cigarette puffs chosen and taken during choice trials. During operant response sessions, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. During cue-reactivity sessions, primary measures include craving, mood, and autonomic responsivity (heart rate, blood pressure, skin conductance, and skin temperature).
Genetic Measures
The following genetic polymorphisms will be assayed: 1) C/T rs2023239 variant of the CB1R gene, 2) the Ser/Gly rs6280 variant of DRD3 gene, and 3) variants of the CYP2A6 gene.
Secondary Measures
Secondary study measures include baseline smoking history, FTND, TCQ-SF, mood form, CO, and urinary cotinine and 3-hydroxycotinine. The ratio of 3-hydroxycotinine/cotinine is a phenotypic biomarker of the rate of nicotine metabolism, which has been shown to be associated with CYP2A6 genotype, level of nicotine dependence, various smoking behaviors, and treatment outcome.
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine Reinforcement, Tobacco Craving, Behavior Genetics, Smoking
- Medical subject headings
- Tobacco Use Disorder, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice of nicotine cigarettes; cue-elicited craving
Secondary outcomes (1)
smoking history measures; variants of several genes related to nicotine additions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study start16 Mar 2010
- Study completion29 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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
- Time perspective
- Other
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen J Heishman, Ph.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505725
- Sponsor's protocol ID
- 999910456
- Other IDs
- 10-DA-N456
- Status last verified
- 29 Nov 2013
- First submitted
- 4 Jan 2012
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Bickel WK, Hughes JR, DeGrandpre RJ, Higgins ST, Rizzuto P. Behavioral economics of drug self-administration. IV. The effects of response requirement on the consumption of and interaction between concurrently available coffee and cigarettes. Psychopharmacology (Berl). 1992;107(2-3):211-6. doi: 10.1007/BF02245139.
PubMed 1615122Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire. Addict Behav. 2007 May;32(5):912-23. doi: 10.1016/j.addbeh.2006.06.028. Epub 2006 Jul 27.
PubMed 16875787Carter BL, Tiffany ST. Meta-analysis of cue-reactivity in addiction research. Addiction. 1999 Mar;94(3):327-40.
PubMed 10605857
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. 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
- NCT01505725
- Acronym / sponsor ID
- 999910456
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine Reinforcement, Tobacco Craving, Behavior Genetics, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 16 Mar 2010
- Study completion
- 29 Nov 2013
- First posted
- 6 Jan 2012 (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.
Background:
- Researchers have been studying behavioral components of nicotine addiction by looking at how drugs have a reinforcing effect, connecting the stimulation provided by the drug (nicotine) to the behavior that produces it (smoking). Based on previous studies, researchers are interested in learning more about how nicotine affects current smokers' responses to psychological tests and smoking-related cues, and in studying whether certain kinds of genetic background may affect smokers' responses to these kinds of studies.
Objectives:
- To compare the effect of nicotine versus denicotinized cigarettes during specific psychological tests.
- To compare the effects of smoking cues versus neutral cues on craving, mood, and autonomic response.
- To study the effect of genes on nicotine reinforcement and smoking-cue reactivity.
Eligibility:
- Individuals between 18 and 64 years of age who are current smokers (at least 10 cigarettes per day for at least 1 year) and are not currently interested in reducing their smoking or seeking treatment for tobacco dependence.
Design:
- Pilot session:
- Participants will practice smoking using the measuring equipment that will be used in the study.
- After successful practice, participants will read or listen to music for 1 hour, during which they are not allowed to smoke.
- After the 1-hour period, participants will sample study cigarettes that have different levels of nicotine, and will be asked to guess whether the cigarettes are normal study cigarettes or denicotinized cigarettes.
- Baseline session:
- Blood, urine, and breath samples will be taken at the start of the session.
- Participants will smoke part of an initial cigarette, and then will read or listen to music for 1 hour, during which they are not allowed to smoke.
- After the 1-hour period, participants will give another breath sample and will complete questionnaires about mood and concentration levels.
- Trial sessions:
- Participants will smoke study cigarettes, and will be asked to either respond to questions about perceived nicotine levels in the cigarettes or press a lever for the chance to be rewarded with additional puffs of the cigarette. After the session, participants will give another breath sample and will complete questionnaires about mood and concentration levels.
- Participants will also participate in cue-reactivity sessions to test the body's physiological response to smoking cues (a pack of cigarettes) and neutral cues (a pack of unsharpened pencils). After the session, participants will complete questionnaires on mood and concentration 15, 30, 45, and 60 minutes after the session.
- At the conclusion of the last experimental session, participants will discuss the study with researchers, and may receive a referral list of smoking treatment programs.
Detailed description
Objectives: 1) to compare the reinforcing efficacy of nicotine versus denicotinized cigarettes using a forced choice and an operant response procedure, 2) to compare the effects of smoking cues versus neutral cues on craving, mood, and autonomic responsivity, and 3) to explore potential associations between several genetic polymorphisms and the phenotypic measures of nicotine reinforcement and smoking-cue reactivity.
Study population: 175 adult smokers (35 for pilot study I, 60 for pilot stufy II and 80 for main study).
Design: Placebo-controlled, within-subjects design. Pilot studies will entail 1-2 sessions. Main study will entail one baseline/adaptation session and 5-10 experimental sessions.
Outcome Measures:
Behavioral Measures
During forced-choice sessions, primary measure is the percentage of nicotine cigarette puffs chosen and taken during choice trials. During operant response sessions, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. During cue-reactivity sessions, primary measures include craving, mood, and autonomic responsivity (heart rate, blood pressure, skin conductance, and skin temperature).
Genetic Measures
The following genetic polymorphisms will be assayed: 1) C/T rs2023239 variant of the CB1R gene, 2) the Ser/Gly rs6280 variant of DRD3 gene, and 3) variants of the CYP2A6 gene.
Secondary Measures
Secondary study measures include baseline smoking history, FTND, TCQ-SF, mood form, CO, and urinary cotinine and 3-hydroxycotinine. The ratio of 3-hydroxycotinine/cotinine is a phenotypic biomarker of the rate of nicotine metabolism, which has been shown to be associated with CYP2A6 genotype, level of nicotine dependence, various smoking behaviors, and treatment outcome.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Choice of nicotine cigarettes; cue-elicited craving
1 secondary outcome
smoking history measures; variants of several genes related to nicotine additions
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 5 Apr 2018.
- Background: PubMed 1615122Bickel WK, Hughes JR, DeGrandpre RJ, Higgins ST, Rizzuto P. Behavioral economics of drug self-administration. IV. The effects of response requirement on the consumption of and interaction between concurrently available coffee and cigarettes. Psychopharmacology (Berl). 1992;107(2-3):211-6. doi: 10.1007/BF02245139.
- Background: PubMed 16875787Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Confirmatory factor analyses and reliability of the modified cigarette evaluation questionnaire. Addict Behav. 2007 May;32(5):912-23. doi: 10.1016/j.addbeh.2006.06.028. Epub 2006 Jul 27.
- Background: PubMed 10605857Carter BL, Tiffany ST. Meta-analysis of cue-reactivity in addiction research. Addiction. 1999 Mar;94(3):327-40.
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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.
Stephen J Heishman, Ph.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
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 5 Apr 2018. 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 United States. 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?
Choice of nicotine cigarettes; cue-elicited craving. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01505725, which also lists 3 linked publications.
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 5 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.