Effects of Smoking Environment on Craving and Smoking

NCT02416986 | Completed

• 2 other identifiers: Pro00056221R01DA038442-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Joseph McClernon, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 15, 2015
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 31, 2017

Record last verified: 2016-08

Locations

US (1)