Effects of Smoking Environment on Craving and Smoking (CC2pilot)

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: 6 hour smoking abstinence; Behavioral: Delay to Smoking Task (smoking cues); Behavioral: Delay to Smoking Task (nonsmoking cues)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-report craving measured by the cue-exposure rating scale		at 0 minutes, +30 minutes, +60 minutes and following first cigarette
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
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Joseph McClernon, PhD, Duke University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: April 8, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Pro00056221; R01DA038442-01 (U.S. NIH Grant/Contract)