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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05825001
Other study ID # I 2684022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2024
Est. completion date February 22, 2025

Study information

Verified date May 2024
Source Roswell Park Cancer Institute
Contact Christine Sheffer
Phone 716-845-1186
Email Christine.Sheffer@roswellpark.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial evaluates the effectiveness of active episodic future thinking (EFT) stimuli for reducing cigarette consumption in cigarette smokers. EFT is an innovative framing method shown to significantly activate brain regions involved in future thinking, planning, and other executive functions. Active EFT stimuli are positive events, unrelated to smoking, that participants anticipate, look forward to, and can vividly imagine happening up to 1 year in the future. Control EFT stimuli are positive past events, unrelated to smoking, that participants can vividly remember happening in the recent past. Active EFT stimuli may help reduce cigarette consumption among cigarette smokers by exposing them to personally relevant future oriented stimuli.


Description:

PRIMARY OBJEECTIVE: I. To evaluate the efficacy of episodic future thinking (EFT) for smoking cessation. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I (ACTIVE): Participants receive the active EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study. ARM II (CONTROL): Participants receive the control EFT stimulus and use the iCOquit Smokerlyzer carbon monoxide monitor on study.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date February 22, 2025
Est. primary completion date February 22, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Smoke >= 10 cigarettes daily - > 32 on the Vividness of Visual Imagery Questionnaire (VVIQ) - No regular use of other tobacco products - In possession of a smartphone with text messaging capabilities - Willing to quit smoking in the next 30 days - Low socioeconomic status Exclusion Criteria: - Unable or unwilling to provide verbal consent - Unable or unwilling to provide data to the research team - Current use of nicotine replacement therapy, bupropion, or varenicline - Use of drugs of abuse in the past 30 days - Living in the same household as a participant already enrolled in this study

Study Design


Related Conditions & MeSH terms

  • Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
Smoking Cessation Intervention
Receive active EFT stimulus
Smoking Cessation Intervention (control)
Receive control EFT stimulus
Other:
Medical Device Usage and Evaluation
Use iCOquit Smokerlyzer carbon monoxide monitor

Locations

Country Name City State
United States Roswell Park Comprehensive Cancer Center Buffalo New York

Sponsors (1)

Lead Sponsor Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of carbon monoxide on breath Will be measured by ICOquit Smokerlyzer From baseline up to 30 days
Secondary Reduction in delay discounting rate participants will be guided to imagine the situational and sensory details for each of the stimuli until the vividness scores are = 4 on a scale of 1-5 (1=very low, 5=very high). Up to 30 days
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