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In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence

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ClinicalTrials.gov Identifier: NCT02938403
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Smoking Reduction or Abstinence Behavioral: In vivo counseling Behavioral: Standard Smoking Cessation Counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence
Actual Study Start Date : January 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938403


Contacts
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Contact: Aaron Sellers, B.S. 205.917.3784 ext 120 aaronsellers@uabmc.edu

Locations
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United States, Alabama
UAB Substance Abuse Recruiting
Birmingham, Alabama, United States
Contact: Aaron Sellers, B.S.    205-917-3784 ext 120    aaronsellers@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Karen Cropsey, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02938403     History of Changes
Other Study ID Numbers: R01DA039678 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action