Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-01-03 @ 8:28 AM
Study NCT ID:
NCT02938403
Status:
COMPLETED
Last Update Posted:
2025-04-07
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence
Sponsor:
University of Alabama at Birmingham
Organization:
Study Overview
Official Title:
In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to determine the efficacy of a smoking cessation intervention (nicotine replacement therapy (NRT) and counseling) done in a systematized manner with participants recruited from the UAB Substance Abuse Program. The definition of In Vivo experience is: use of the NRT medication during the session using specialized counseling focused around their experience of using NRT, including how the use of NRT may help them quit smoking, side effects, and smoking cessation expectancies. In this study those in the In Vivo group will put the patch on during Session 1 and given nicotine gum in Session 2 and will discuss the experience of wearing the patch or chewing the gum while they are in session. The control group will not put on the patch or chew gum during the sessions but will be given standard counseling regarding quitting smoking.
Detailed Description:
Aim 1: Compare the efficacy of an In Vivo experiential intervention to a standard treatment control group for smoking cessation. The goal of this aim will be to compare the rates of point prevalence abstinence at the 6 month post-intervention follow-up. It is expected that smokers who receive the behavioral experience of the NRT In Vivo intervention will have higher rates of abstinence at the 6 month follow-up compared to the control group. Aim 2: Compare medication adherence between groups over the 12 week intervention. The goal of this aim is to determine the impact of the In Vivo behavioral experience intervention on promoting medication adherence to NRT. It is expected that individuals in the In Vivo NRT group will have better medication adherence relative to control participants. Exploratory: Examine moderators and mediators of the experimental intervention on smoking abstinence. The goal of this aim is to explore whether demographic and smoking characteristics (e.g., sex, race, nicotine dependence, motivational status, legal charges) moderate the effect of treatment on abstinence after 12 weeks of treatment and 6-month follow-up. In addition, we will look at changes in expectancies about NRT, medication adherence, and withdrawal symptoms to determine if these changes mediate the relationship between the experimental intervention and smoking abstinence.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA039678 | NIH | None | https://reporter.nih.gov/quic… | View |