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Completed

NCT Number: NCT02416986

Effects of Smoking Environment on Craving and Smoking

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6 hour smoking abstinence

Behavioral

Delay to Smoking Task (smoking cues)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: CC2pilot

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2015
Registry last updated
Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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