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Study of Smoking Abstinence

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ClinicalTrials.gov Identifier: NCT01035632
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : July 2, 2017
Sponsor:
Information provided by:

Study Description
Brief Summary:

Background:

- Relapse following cigarette abstinence remains a common problem for smokers who are attempting to quit. Most research has focused on the acute withdrawal phase that occurs within the first 48 hours to 1 week after quitting; however, more information is needed on the experiences of smokers in longer durations of abstinence.

Objectives:

  • To study the effects of long-term smoking abstinence.
  • To study the effects of cigarette-related cues on craving in longer periods of smoking abstinence.

Eligibility:

- Individuals at least 18 years of age who are current smokers (at least 10 cigarettes per day) and who want to quit but are not currently attempting to quit.

Design:

  • Participants will be randomly assigned to abstain from all nicotine use for 7, 14, or 35 days. A fourth group of participants will also abstain for 35 days, but will undergo more testing sessions than the other groups.
  • All participants will have an initial orientation session in which they will complete questionnaires about their smoking habits and will respond to smoking-related cues to provide information about their cravings.
  • Participants will visit the clinic daily during their abstinence period, and provide urine and breath samples to test for tobacco use. Participants will receive compensation for every day that they do not use tobacco.
  • On the end day of the abstinence period, participants will return to the clinic, provide urine and breath samples, and undergo testing of their responses to smoking-related cues. Participants in the fourth group will have these tests on Days 7, 14, and 35 of abstinence; other participants will have the tests only once, at the end of their abstinence period.
  • After the required abstinence period, participants will enter a 5-day step-down period. They will continue to report to the clinic for breath and urine testing, and they will receive payments for abstinence that decrease in value across days.
  • After the step-down period, for the final 12 days of the study, participants will report to the clinic every 3 days to give urine and breath samples and to report the number of cigarettes smoked.

Condition or disease
Substance Abuse Disorders

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 210 participants
Time Perspective: Prospective
Official Title: Study of Smoking Abstinence
Study Start Date : April 7, 2006
Estimated Study Completion Date : January 12, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    1. Age 18 years or older
    2. Smoke at least 10 cigarettes per day, answer yes to the question Do you want to quit smoking eventually?, but no to the question Are you currently planning to quit?

EXCLUSION CRITERIA:

  1. Medical conditions that would contraindicate participation
  2. Medical conditions requiring medications that would contraindicate participation
  3. Electrocardiogram suggestive of cardiovascular disease, symptomatic arrhythmia, QTc interval > 450 ms; heart block greater than first degree.
  4. Any current Axis I psychiatric disorder including Substance Use Disorder (except Nicotine Dependence), or any history of psychosis;
  5. Cognitive impairment (estimated IQ less than 80)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035632


Locations
United States, Maryland
National Institute on Drug Abuse, Biomedical Research Center (BRC)
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
More Information

Publications:
ClinicalTrials.gov Identifier: NCT01035632     History of Changes
Obsolete Identifiers: NCT00385060
Other Study ID Numbers: 999906411
06-DA-N411
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: January 12, 2011

Keywords provided by National Institutes of Health Clinical Center (CC):
Craving
Incubation
Relapse
Smoking Cues
Cortisol

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders