NCT02663882

Brief Summary

The purpose of this study is to learn more about self-control and adults who smoke cigarettes. It has been suggested that people can improve self-control by practicing tasks that require the use of self-control (such as delaying cigarettes or sitting up as straight as possible). The goal of this study is to learn about whether scores on self-control and other measures will change after one week of practicing self-control tasks at home. We believe that adults who smoke cigarettes will show better self-control after practicing tasks for a week.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 14, 2020

Completed
Last Updated

December 14, 2020

Status Verified

November 1, 2020

Enrollment Period

3.3 years

First QC Date

January 19, 2016

Results QC Date

October 19, 2020

Last Update Submit

November 17, 2020

Conditions

Keywords

smokingself control

Outcome Measures

Primary Outcomes (1)

  • Self- Control as Measured by the Change in the Length of Time Participants Can Hold a Hand-grip at Baseline and Follow-up (One Week After Baseline)

    Participants were instructed to squeeze a hand-grip exerciser as long as possible and research staff used a stopwatch to time the length of time that the hand-grip is squeezed. A wad of paper was inserted between the handles of the hand-grip and timing stopped when the paper fell from the hand-grip indicating that the participant had released the hand-grip. The hand-grip was held before and after a thought suppression exercise that was meant to diminish self-control in order to control for individual hand strength. Self-control was measured as the difference in the length of time holding the hand-grip before and after the thought suppression exercise at each appointment (baseline and one week followup). Change in self-control due to task practice was measured as \[self-control at the second study appointment one week after the first appointment\] minus \[self-control at the first study appointment\].

    Baseline, one week followup after baseline

Secondary Outcomes (3)

  • Self-Control as Measured by the Change in Self-reported Overall Self-Control at Baseline and Follow-up

    2 assessments of this item over one week (baseline appointment, follow up appointment 1 week after baseline)

  • Change in Smoking Quantity (Cigarettes Smoked Per Day) Measured at Baseline and at Follow-up

    Baseline, follow up appointment one week after baseline

  • Change in Expired Breath Carbon Monoxide Level

    Baseline, follow up one week after baseline

Study Arms (2)

smoking-related self control task

EXPERIMENTAL

self control practice - smoking related task

Behavioral: self control practice - smoking related task

Non-smoking-related self control task

ACTIVE COMPARATOR

self control practice - non-smoking related task

Behavioral: self control practice - non-smoking related task

Interventions

participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day

smoking-related self control task

participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day

Non-smoking-related self control task

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be adults who are 18 years of age or older
  • Currently smoke ≥10 cigarettes per day biochemically confirmed by an expired breath carbon monoxide (CO) level ≥8
  • Report that they are not currently attempting to quit smoking and not currently receiving smoking cessation treatment (e.g., counseling, nicotine replacement therapy, bupropion, varenicline)
  • Have the capacity to give informed consent
  • Be English-speaking.

You may not qualify if:

  • Children under the age of 18
  • Non-English speakers
  • Those who do not have the capacity to consent will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smoking and Nicotine Dependence Research Laboratory

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

SmokingSelf-Control

Condition Hierarchy (Ancestors)

BehaviorSocial Behavior

Results Point of Contact

Title
Dr. Andrea Weinberger
Organization
Yeshiva University

Study Officials

  • Andrea H Weinberger, PhD

    Yeshiva University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 26, 2016

Study Start

April 1, 2016

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

December 14, 2020

Results First Posted

December 14, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations