In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2018 |
| Start Date: | January 2017 |
| End Date: | August 2021 |
| Contact: | Aaron Sellers, B.S. |
| Email: | aaronsellers@uabmc.edu |
| Phone: | 205.917.3784 |
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.
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.
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.
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.
Inclusion Criteria:
- At least 18 years of age,
- Under criminal justice supervision and expecting to remain under supervision for 9
months,
- Smoked at least 5 cigarettes per day for the last 12 months,
- Expire carbon dioxide (CO)> 10 ppm.
- Must be able to read and speak English.
- Women of child-bearing potential must be using adequate birth control.
Exclusion Criteria:
- Pregnant or breastfeeding women,
- Non-English speaking,
- Living in an restricted environment that does not allow smoking,
- Known sensitivity to nicotine replacement or allergy to adhesive used in nicotine
patches,
- Cognitive impairment or major untreated mental illness that interferes with the
informed consent process,
- Within 6 months post-myocardial infarction or untreated severe angina,
- Latex allergy,
- Daily or exclusive use of other tobacco products (e.g. cigars, e-cigarettes).
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