Study of Smoking Abstinence

NCT01035632 | Completed

• 2 other identifiers: 99990641106-DA-N411
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Abuse Disorders

Keywords

Craving; Incubation; Relapse; Smoking Cues; Cortisol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• 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?

You may not qualify if:

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

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)

• Alsene KM, Li Y, Chaverneff F, de Wit H. Role of abstinence and visual cues on food and smoking craving. Behav Pharmacol. 2003 Mar;14(2):145-51. doi: 10.1097/00008877-200303000-00006.

  PMID: 12658075 BACKGROUND

• Alsene KM, Mahler SV, de Wit H. Effects of d-amphetamine and smoking abstinence on cue-induced cigarette craving. Exp Clin Psychopharmacol. 2005 Aug;13(3):209-18. doi: 10.1037/1064-1297.13.3.209.

  PMID: 16173884 BACKGROUND

• Balleine BW, Dickinson A. Goal-directed instrumental action: contingency and incentive learning and their cortical substrates. Neuropharmacology. 1998 Apr-May;37(4-5):407-19. doi: 10.1016/s0028-3908(98)00033-1.

  PMID: 9704982 BACKGROUND

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: April 7, 2006
• Study Completion: January 12, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-01-12

Locations

US (1)