Effects of Smoking Environment on Craving and Smoking

Smoking Clinical Trial

— CC2pilot  

Official title:

Effects of Smoking Environment on Craving and Smoking: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416986
• Other study ID #: Pro00056221
• Secondary ID: R01DA038442-01
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: January 30, 2017
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to evaluate the effects of exposure to standard smoking environments on ability to resist smoking as measured with a Delay to Smoking Task. The results of this study will inform whether the Delay to Smoking Task is a sensitive measure for evaluating environment-provoked craving and smoking behavior.

Description:

Adult smokers (n=25) will complete 4 visits and a 6 month follow-up phone call. Participants will complete a Delay to Smoking Task following 6 hours smoking abstinence. The task involves viewing pictures of smoking and non-smoking locations and participants will have the choice to smoke a cigarette at any time during the session. A monetary reinforcer will be provided for each 6-minute period that a participant resists smoking. Once participants stop the task they can choose to smoke as much or a little as they want for the next 30 minutes. Participants will be provided with a smoking tab. Each cigarette they light will cost them from their tab. Measurements of tobacco craving, emotion ratings, and nicotine withdrawal will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• generally healthy

• between the ages of 18 and 55

• smoking an average of 5 cigarettes per day for at least one year

• breath CO level > 8 ppm (if = 8 ppm, then NicAlert Strip = 6)

• no interest in quitting smoking for the duration of time required for the experiment

Exclusion Criteria:

• inability to attend all required experimental sessions

• use of psychoactive medications

• use of smokeless tobacco

• current alcohol or drug abuse

• use of illegal drugs as measured by urine drug screen (excluding marijuana)

• current use of nicotine replacement therapy or other smoking cessation treatment

• Blood Alcohol Level (BAL) > 0.00

• use of other tobacco products or e-cigarettes more than 9 days in the past 30 days

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• 6 hour smoking abstinence

• Delay to Smoking Task (smoking cues)
Participants will be presented with an unlit cigarette of their brand and an opportunity to initiate ad lib smoking at any time during the 60-minute task. During this period, participants will be allowed to read books or magazines, but will hear a tone alerting them to view cues (standard smoking environments) for the final minute of each 6-minute period. A monetary reinforcer will be provided for each 6-minute period that a participant resists smoking. Once participants stop the task they can choose to smoke as much or a little as they want for the next 30 minutes. Participants will be provided with a smoking tab. Each cigarette they light will cost them from their tab.
• Delay to Smoking Task (nonsmoking cues)
Participants will be presented with an unlit cigarette of their brand and an opportunity to initiate ad lib smoking at any time during the 60-minute task. During this period, participants will be allowed to read books or magazines, but will hear a tone alerting them to view cues (standard nonsmoking environments) for the final minute of each 6-minute period. A monetary reinforcer will be provided for each 6-minute period that a participant resists smoking. Once participants stop the task they can choose to smoke as much or a little as they want for the next 30 minutes. Participants will be provided with a smoking tab. Each cigarette they light will cost them from their tab.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in self-report craving measured by the cue-exposure rating scale		at 0 minutes, +30 minutes, +60 minutes and following first cigarette
Primary	Difference in number of subjects who initiate smoking during the smoking cue Delay to Smoking Task compared to the nonsmoking cue Delay to Smoking Task	If participant initiates smoking a cigarette during the Delay to Smoking Task	following start of Delay to Smoking Task, up to 60 minutes
Primary	Number of minutes to first puff	Number of minutes to first puff of cigarette will be recorded for participants that initiate smoking	following start of Delay to Smoking Task, up to +60 minutes