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Clinical Trials/NCT02416986
NCT02416986CompletedNot Applicable

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

Duke University2 sites in 1 country41 target enrollmentStarted: October 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
41
Locations
2
Primary Endpoint
Change in self-report craving measured by the cue-exposure rating scale

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Change in self-report craving measured by the cue-exposure rating scale

Time Frame: 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

Time Frame: following start of Delay to Smoking Task, up to 60 minutes

If participant initiates smoking a cigarette during the Delay to Smoking Task

Number of minutes to first puff

Time Frame: following start of Delay to Smoking Task, up to +60 minutes

Number of minutes to first puff of cigarette will be recorded for participants that initiate smoking

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Duke University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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