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

NCT01505725 | Completed

• 2 other identifiers: 99991045610-DA-N456
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Nicotine Dependence

Keywords

Nicotine Reinforcement; Tobacco Craving; Behavior Genetics; Smoking

Outcome Measures

Primary Outcomes (1)

• Choice of nicotine cigarettes; cue-elicited craving

Secondary Outcomes (1)

• smoking history measures; variants of several genes related to nicotine additions

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse, Biomedical Research Center (BRC)

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• 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.

  PMID: 1615122 BACKGROUND

• Cappelleri 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.

  PMID: 16875787 BACKGROUND

• Carter BL, Tiffany ST. Meta-analysis of cue-reactivity in addiction research. Addiction. 1999 Mar;94(3):327-40.

  PMID: 10605857 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Stephen J Heishman, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 6, 2012
• Study Start: March 16, 2010
• Study Completion: November 29, 2013
• Last Updated: April 5, 2018

Record last verified: 2013-11-29

Locations

US (1)