Dual Use Approach Bias Training for Nicotine Addiction
Primary Purpose
Tobacco Smoking, Electronic Cigarette Use, Substance Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CC+ECIG Condition
CC Condition
Sham Condition
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Smoking
Eligibility Criteria
Inclusion Criteria:
- At least 18 years of age
- At least daily CC use for the previous month
- ECIG use with nicotine at least daily for the previous month
- Motivation to quit nicotine (BOTH CC and ECIG; ≥ 5 on a 0-10 scale)
- Ability to speak and read English fluently
- Not have decreased number of cigarettes by more than half in the past month
- Own an android smartphone (for EMA).
Exclusion Criteria:
- Current psychotherapy or pharmacotherapy for mental illness or addiction
- Current use of nicotine replacement therapy, Zyban, or Chantix
- Limited mental capacity or inability to provide informed consent
- Insufficient command of the English language (>6th grade English literacy level required)
Sites / Locations
- RESTORE LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
CC+ECIG Condition
CC Only Condition
Sham Condition
Arm Description
Combustible Cigarette (CC) and Electronic Cigarette (ECIG) users will be trained to avoid CC and ECIG-related images and approach positive images.
Participants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images.
Participants will pull and push all pictures of CC and ECIG images equally with no preference towards one or the other.
Outcomes
Primary Outcome Measures
Biochemically-Verified Point Prevalence Abstinence
Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)
Prolonged Abstinence
Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)
Lapse
Time to first use (CC and/or ECIG)
Nicotine Relapse
7th day on which CC or ECIG occurs
Secondary Outcome Measures
Questionnaire of Smoking Urges-Brief (QSU-Brief)
The Brief Questionnaire of Smoking Urges (QSU-Brief) consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now).
Questionnaire of Vaping Craving
The Questionnaire of Vaping Craving is a modified measure of the QSU and consists of 10 statements about the respondent's feelings and thoughts about his or her desire to vape as he or she is completing the questionnaire (i.e., right now).
Approach Bias
The approach-avoidance task (AAT) is a 15-minute computerized task instructs participants to use a joystick to either pull toward themselves or push away from themselves images presented on the screen that vary in content (i.e., substance-related, neutral, positive) and format (e.g., right- or left-tilted).
Biochemically-Verified Point Prevalence Abstinence
Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)
Prolonged Abstinence
Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)
Lapse
Time to first use (CC and/or ECIG)
Nicotine Relapse
7th day on which CC or ECIG occurs
Full Information
NCT ID
NCT05306158
First Posted
February 16, 2022
Last Updated
December 6, 2022
Sponsor
University of Houston
1. Study Identification
Unique Protocol Identification Number
NCT05306158
Brief Title
Dual Use Approach Bias Training for Nicotine Addiction
Official Title
Approach Bias Retraining for Nicotine Addiction Among Dual Combustible and Electronic Cigarette Users
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The present project will evaluate the initial efficacy of approach bias retraining among dual combustible cigarette (CC) and electronic cigarette (ECIG) users. The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining.
Detailed Description
The study employs a randomized controlled design to follow 90 experienced dual CC/ECIG users motivated to quit nicotine as they engage in a self-guided quit attempt following approach bias retraining. Participants will be randomized to one of three approach bias retraining conditions: (1) CC+ECIG; (2) CC only; or (3) sham (control). Participants will complete a phone pre-screener, baseline (week 1 of study participation), 4 approach bias retraining sessions in laboratory (with quit day scheduled for the 4th session; weeks 2-5 of study participation), and follow-up assessments at 4- and 6-weeks post-intervention (i.e., weeks 9 and 11 of study participation, respectfully). Participants also will complete ecological momentary assessments (EMA) of CC smoking, ECIG use, and CC and ECIG urges/cravings for 14 days post-intervention (i.e., weeks 5-7 of study participation) on Internet capable smartphones. The only time data will be collected is when participants complete EMA assessments or follow up surveys using the REDCap app on the smartphone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Smoking, Electronic Cigarette Use, Substance Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are three arms, one intervention (CC+ECIG Condition), one active comparator (CC Condition), and one Sham (control) arm which are randomly assigned at the same time (baseline) and are implemented in parallel.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CC+ECIG Condition
Arm Type
Experimental
Arm Description
Combustible Cigarette (CC) and Electronic Cigarette (ECIG) users will be trained to avoid CC and ECIG-related images and approach positive images.
Arm Title
CC Only Condition
Arm Type
Active Comparator
Arm Description
Participants in this arm will be trained to avoid only combustible cigarette images, not electronic cigarettes images.
Arm Title
Sham Condition
Arm Type
Sham Comparator
Arm Description
Participants will pull and push all pictures of CC and ECIG images equally with no preference towards one or the other.
Intervention Type
Other
Intervention Name(s)
CC+ECIG Condition
Intervention Description
Participants will push CC- and ECIG-related pictures.
Intervention Type
Other
Intervention Name(s)
CC Condition
Intervention Description
Participants will push CC-related images and push and pull ECIG-related pictures equally often.
Intervention Type
Other
Intervention Name(s)
Sham Condition
Other Intervention Name(s)
Control
Intervention Description
Participants will pull and push CC- and ECIG-related pictures equally often.
Primary Outcome Measure Information:
Title
Biochemically-Verified Point Prevalence Abstinence
Description
Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)
Time Frame
Week 9 of participation
Title
Prolonged Abstinence
Description
Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)
Time Frame
Week 9 of participation
Title
Lapse
Description
Time to first use (CC and/or ECIG)
Time Frame
Week 9 of participation
Title
Nicotine Relapse
Description
7th day on which CC or ECIG occurs
Time Frame
Week 9 of participation
Secondary Outcome Measure Information:
Title
Questionnaire of Smoking Urges-Brief (QSU-Brief)
Description
The Brief Questionnaire of Smoking Urges (QSU-Brief) consists of 10 statements about the respondent's feelings and thoughts about his or her desire to smoke cigarettes as he or she is completing the questionnaire (i.e., right now).
Time Frame
Week 1-7, 9, and 11 of participation
Title
Questionnaire of Vaping Craving
Description
The Questionnaire of Vaping Craving is a modified measure of the QSU and consists of 10 statements about the respondent's feelings and thoughts about his or her desire to vape as he or she is completing the questionnaire (i.e., right now).
Time Frame
Week 1-7, 9, and 11 of participation
Title
Approach Bias
Description
The approach-avoidance task (AAT) is a 15-minute computerized task instructs participants to use a joystick to either pull toward themselves or push away from themselves images presented on the screen that vary in content (i.e., substance-related, neutral, positive) and format (e.g., right- or left-tilted).
Time Frame
Weeks 2-5 of participation
Title
Biochemically-Verified Point Prevalence Abstinence
Description
Biochemically-verified (urine and/or expired carbon monoxide reading) and self-reported 7-day abstinence prior to follow up (CC and/or ECIG)
Time Frame
Week 11 of participation
Title
Prolonged Abstinence
Description
Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG)
Time Frame
Week 11 of participation
Title
Lapse
Description
Time to first use (CC and/or ECIG)
Time Frame
Week 11 of participation
Title
Nicotine Relapse
Description
7th day on which CC or ECIG occurs
Time Frame
Week 11 of participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least 18 years of age
At least 15 days of CC use for the previous month
ECIG use with nicotine at least 15 days for the previous month
Motivation to quit nicotine (BOTH CC and ECIG; ≥ 5 on a 0-10 scale)
Ability to speak and read English fluently
Not have decreased number of cigarettes by more than half in the past month
Own an android smartphone (for EMA).
Exclusion Criteria:
Current psychotherapy or pharmacotherapy for mental illness or addiction
Current use of nicotine replacement therapy, Zyban, or Chantix
Limited mental capacity or inability to provide informed consent
Insufficient command of the English language (>6th grade English literacy level required)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorra Garey, Ph.D
Phone
713-743-8056
Email
llgarey@uh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorra Garey, Ph.D
Organizational Affiliation
Assistant Research Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
RESTORE Laboratory
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pam Nizio, BA
Phone
713-743-0123
Email
niziopam@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will provide de-identified data from this project to interested individuals one year following achievement of the aims of the project (i.e., publication of the main outcome paper). These data will be provided in digital format (i.e., disk) with clear labels for all variables. Data will be released directly by the investigators providing evidence of their institution's IRB approval for planned analyses of the data. Our team will be available to address queries.
IPD Sharing Time Frame
One year after completion upon request.
IPD Sharing Access Criteria
Upon specific IRB approval and request from researchers.
Learn more about this trial
Dual Use Approach Bias Training for Nicotine Addiction
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