Nicotine DependenceNCT01148355
Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Adolescent Smokers
An observational study of Nicotine Dependence, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2008to 14 Jan 2011
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 13-17 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.
Who cannot join
- 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
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:
- 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.
Read more
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.
Read the detailed description
Objective:
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.
Study population:
25 adolescents who smoke at least 5 cigarettes per day.
Design:
Comparison-controlled, within-subjects design.
Outcome Measures:
During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood, tobacco craving, smoking expectancies, nicotine dependence, and urinary cotinine and 3-hydroxycotinine.
- Conditions
- Nicotine Dependence
- Keywords
- Craving, Moods, Adolescents, Nicotine, Reinforcement
- Medical subject headings
- Tobacco Use Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study start10 Jun 2008
- Study completion14 Jan 2011
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
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01148355
- Sponsor's protocol ID
- 999908435
- Other IDs
- 08-DA-N435
- Status last verified
- 14 Jan 2011
- First submitted
- 19 Jun 2010
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 17558821Bickel 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 1615122Corrigall WA. Nicotine self-administration in animals as a dependence model. Nicotine Tob Res. 1999 Mar;1(1):11-20. doi: 10.1080/14622299050011121.
PubMed 11072385
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smoking Cues on Tobacco Craving Responses and the Reinforcing Efficacy of Cigarettes in Adolescent Smokers
- ClinicalTrials.gov ID
- NCT01148355
- Acronym / sponsor ID
- 999908435
- Conditions
- Nicotine Dependence
- Keywords
- Craving, Moods, Adolescents, Nicotine, Reinforcement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- 10 Jun 2008
- Study completion
- 14 Jan 2011
- First posted
- 22 Jun 2010 (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:
- 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.
Detailed description
Objective:
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.
Study population:
25 adolescents who smoke at least 5 cigarettes per day.
Design:
Comparison-controlled, within-subjects design.
Outcome Measures:
During cue trials, primary measures include craving (TCQ-SF, VAS), mood (mood form, VAS), and autonomic (heart rate, blood pressure, skin conductance) responsivity. During self-administration trials, primary measures include breakpoint (final ratio completed), total number of responses, and number of cigarette puffs earned and taken. Secondary measures include baseline smoking history, mood, tobacco craving, smoking expectancies, nicotine dependence, and urinary cotinine and 3-hydroxycotinine.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
Key exclusion criteria (6 listed)
- 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
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 17558821Bagot 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.
- 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 11072385Corrigall WA. Nicotine self-administration in animals as a dependence model. Nicotine Tob Res. 1999 Mar;1(1):11-20. doi: 10.1080/14622299050011121.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 6 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01148355, 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 2 Jul 2017.