In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence

April 4, 2025 updated by: Karen Cropsey, University of Alabama at Birmingham
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

517

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • UAB Substance Abuse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In vivo group
Those who receive in vivo counseling and Nicotine Replacement Therapy (NRT)
Behavioral: In vivo counseling
Participants in the intervention group will receive 4 in session nicotine replacement therapy and counseling focused on their experience of using NRT, including positive experiences, side effects and smoking cessation expectancies. They will also received nicotine replacement therapy (nicotine lozenge and patch) to use for smoking cessation.
Active Comparator: Controls
Standard smoking cessation counseling and Nicotine Replacement Therapy (NRT)
Behavioral: Standard Smoking Cessation Counseling
Participants will receive 4 sessions of standard behavioral counseling to address their smoking. In addition, participants will received nicotine replacement therapy (Nicotine lozenge and patch) to use for smoking cessation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking abstinence
Time Frame: 6 months
Smoking abstinence will be defined at 6 months as a CO< or equal to 3ppm and no smoking over the last 7 days
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Institute on Drug Abuse (NIDA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

October 13, 2022

Study Registration Dates

First Submitted

October 17, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimated)

October 19, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • R01DA039678 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Smoking Reduction or Abstinence

Clinical Trials on In vivo counseling

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe