Clinical trial NCT02416986: Effects of Smoking Environment on Craving and Smoking
Official title: Effects of Smoking Environment on Craving and Smoking: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2015-04-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in self-report craving measured by the cue-exposure rating scale
timeFrame: at 0 minutes, +30 minutes, +60 minutes and following first cigarette
measure: 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
timeFrame: following start of Delay to Smoking Task, up to 60 minutes
measure: Number of minutes to first puff
timeFrame: following start of Delay to Smoking Task, up to +60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joseph McClernon, PhD
role: PRINCIPAL_INVESTIGATOR
References: