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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05306158
Other study ID # PAR-19-309
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 3, 2022
Est. completion date November 30, 2024

Study information

Verified date May 2024
Source University of Houston
Contact Lorra Garey, Ph.D
Phone 713-743-8056
Email llgarey@uh.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date November 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Intervention

Other:
CC+ECIG Condition
Participants will push CC- and ECIG-related pictures.
CC Condition
Participants will push CC-related images and push and pull ECIG-related pictures equally often.
Sham Condition
Participants will pull and push CC- and ECIG-related pictures equally often.

Locations

Country Name City State
United States RESTORE Laboratory Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Week 9 of participation
Primary Prolonged Abstinence Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG) Week 9 of participation
Primary Lapse Time to first use (CC and/or ECIG) Week 9 of participation
Primary Nicotine Relapse 7th day on which CC or ECIG occurs Week 9 of participation
Secondary 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). Week 1-7, 9, and 11 of participation
Secondary 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). Week 1-7, 9, and 11 of participation
Secondary 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). Weeks 2-5 of participation
Secondary 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) Week 11 of participation
Secondary Prolonged Abstinence Smoking on fewer than 7 consecutive days or smoking fewer than once each week over 2 consecutive weeks (CC and/or ECIG) Week 11 of participation
Secondary Lapse Time to first use (CC and/or ECIG) Week 11 of participation
Secondary Nicotine Relapse 7th day on which CC or ECIG occurs Week 11 of participation
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