In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence

NCT02938403 | Completed DMC

• 1 other identifier: R01DA039678
• Study Type: interventional
• Target: 517
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Reduction or Abstinence

Outcome Measures

Primary Outcomes (1)

• Smoking abstinence

  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

Study Arms (2)

In vivo group

EXPERIMENTAL

Those who receive in vivo counseling and Nicotine Replacement Therapy (NRT)

Behavioral: In vivo counseling

Controls

ACTIVE COMPARATOR

Standard smoking cessation counseling and Nicotine Replacement Therapy (NRT)

Behavioral: Standard Smoking Cessation Counseling

Interventions

In vivo counseling BEHAVIORAL

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.

In vivo group

Standard Smoking Cessation Counseling BEHAVIORAL

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.

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UAB Substance Abuse

Birmingham, Alabama, United States

Location

Related Publications (1)

• Hawes ES, Mildrum Chana S, Faust A, Baker JC, Hendricks PS, Azuero A, Lahti AC, Carpenter MJ, Cropsey KL. In vivo Experience With NRT to Increase Adherence and Smoking Abstinence Among Individuals in the Criminal Legal System: Study Protocol for a Randomized Clinical Trial. Front Psychiatry. 2022 Jun 21;13:886680. doi: 10.3389/fpsyt.2022.886680. eCollection 2022.

  PMID: 35800020 DERIVED

MeSH Terms

Conditions

Smoking Reduction

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 19, 2016
• Study Start: January 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: October 13, 2022
• Last Updated: April 7, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)