NCT01148355

Brief Summary

Background:

  • Multiple social, psychological, and environmental factors contribute to adolescents' use of cigarettes. Environmental smoking cues have been shown to play an important role in the maintenance of nicotine addiction and in relapse to smoking. However, few studies have examined craving and cue-reactivity in adolescent smokers, even though craving appears to contribute to ongoing smoking and relapse in this age group.
  • Another factor central to addiction is the rewarding effect of drugs, or the interaction between the person, the drug, and the environmental setting. However, more research is needed on whether environmental cues lead to increased smoking in adolescents. Objectives: \- To determine the effects of smoking versus neutral cues in adolescents who smoke on (1) craving, mood, and autonomic responsivity and (2) the relative reinforcing efficacy of tobacco cigarettes. Eligibility: \- Adolescents 12 to 17 years of age who are current smokers (at least five cigarettes per day for the past 6 months). Design:
  • This study will involve three study visits. Participants will be allowed to smoke before all study sessions and will give a breath carbon monoxide (CO) sample before all sessions. Participants must not use any illicit drugs or alcohol 24 hours before sessions.
  • Visit 1 (baseline session): Participants will provide a urine sample and will be familiarized with the study room and session design.
  • Visits 2 and 3: Participants will be connected to physiological recording devices to measure heart rate, perspiration, and other physical responses. After baseline readings, participants will be exposed to smoking cues at one experimental session and to neutral cues at the other experimental session.
  • Before, during, and after cue presentation, participants will complete self-report measures of mood and craving and have physiological measures taken. They will then be re-exposed to smoking or neutral cues and engage in a self-administration procedure to examine the effect of cues on the reinforcing efficacy of cigarettes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

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

June 10, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2011

Completed
Last Updated

July 2, 2017

Status Verified

January 14, 2011

First QC Date

June 19, 2010

Last Update Submit

June 30, 2017

Conditions

Keywords

CravingMoodsAdolescentsNicotineReinforcement

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • year old males and females
  • smoking at least 5 cigarettes per day for at least 6 months
  • urinary cotinine level greater than or equal to 100 ng/ml (NicAlert(Registered Trademark) reading greater than or equal to 3)
  • medically and psychologically healthy as determined by screening criteria.

You may not qualify if:

  • current interest in reducing or quitting smoking
  • treatment for nicotine dependence in the past 3 months
  • use of nicotine replacement products, bupropion, or varenicline in the past 3 months
  • alcohol and any illicit drug use more than 7 times in the last 14 days
  • current use of any medication that would interfere with the protocol in the opinion of MAI
  • pregnant, nursing, or become pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Bagot KS, Heishman SJ, Moolchan ET. Tobacco craving predicts lapse to smoking among adolescent smokers in cessation treatment. Nicotine Tob Res. 2007 Jun;9(6):647-52. doi: 10.1080/14622200701365178.

    PMID: 17558821BACKGROUND
  • 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: 1615122BACKGROUND
  • Corrigall WA. Nicotine self-administration in animals as a dependence model. Nicotine Tob Res. 1999 Mar;1(1):11-20. doi: 10.1080/14622299050011121.

    PMID: 11072385BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2010

First Posted

June 22, 2010

Study Start

June 10, 2008

Study Completion

January 14, 2011

Last Updated

July 2, 2017

Record last verified: 2011-01-14

Locations