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Trial record 8 of 10 for:    anatabine

NRT Sampling and Selection to Increase Medication Adherence

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ClinicalTrials.gov Identifier: NCT03276780
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Karen Cropsey, University of Alabama at Birmingham

Brief Summary:
To determine the preliminary impact on Nicotine Replacement Therapy (NRT)adherence and examine the underlying mechanisms of action associated with adherence.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Counseling Drug: combination NRT Phase 4

Detailed Description:
Adherence is a critical target for successful smoking cessation, with good adherence associated with a three-fold increase in cessation rates relative to poor adherence. Psychoeducational interventions focused on increasing adherence to NRT do not result in behavioral change (e.g., smoking cessation). Experiential approaches, such NRT sampling with PQAs, are based on learning theory models of behavioral change and have resulted in increased motivation, self-efficacy, adherence, and abstinence relative to psychoeducation or motivational interventions. However, nicotine sampling still relies of the participant using NRT outside of session, which may not occur. Providing an experiential intervention in which the NRT is sampled and any problems with NRT reframed during the session may provide a powerful learning experience that can increase in home sampling with PQAs and long-term adherence, ultimately increasing the likelihood of smoking cessation. This may be particularly relevant for low-income smokers who hold more negative views of NRT, have lower health literacy, and are less likely to use medication during cessation attempts.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: In vivo or standard of care
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NRT Sampling and Selection to Increase Medication Adherence
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : August 31, 2020

Arm Intervention/treatment
Experimental: In vivo
Will receive 4 types of short-acting NRT medication to use in combination with the nicotine patch in each counseling session for four sessions. At the fifth session, participants will select their short acting NRT to use with the patch to make a cessation attempt.
Behavioral: Counseling
Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking

Drug: combination NRT
Both groups will receive combination NRT to help with smoking cessation

Active Comparator: Standard of care
Will receive 4 sessions of behavioral counseling around their smoking. At the fifth session, participants will select their short-acting NRT to use with the nicotine patch based on a product description of each product to make a cessation attempt.
Behavioral: Counseling
Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking

Drug: combination NRT
Both groups will receive combination NRT to help with smoking cessation




Primary Outcome Measures :
  1. Feasibility and acceptability [ Time Frame: 4 months ]
    Rate of recruitment, retention in treatment

  2. Treatment satisfaction and Credibility/expectancies [ Time Frame: 4 months ]
    Questionnaires

  3. Medication adherence [ Time Frame: 4 months ]
    Returning used patches and anatabine/anabasine levels



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:

a) 18 years or older; b) qualifying as low income (as defined by making <150% above the poverty line or <$22,260 as a single or <$45,570 for a family of four); c) Smoking at least 5 cpd for the past year and a CO>8ppm to ensure daily smoking. This relatively low cutoff was chosen due to the expectation of enrolling a large >50% African-American who average <10 CPD compared to Whites who average ~15 CPD.; and d) English speaking.

Exclusion Criteria:

a) Living in a restricted environment (e.g., prison or jail facility, etc.); b) Pregnant or nursing (all women will be required to use an acceptable form of contraception); c) Currently enrolled in a smoking cessation treatment program, using NRT products, or prescribed bupropion or varenicline; d) Known allergy to any of the nicotine replacement products or sensitivity to adhesive used in nicotine patches; e) Trouble breathing, a pulmonary condition, or sinus problems; f) Within one month post-myocardial infarction or untreated severe angina; g) poor dentation or temporomandibular joint (TMJ) problems such as unable to use nicotine gum; h) Cognitive impairment or unstable psychiatric condition that interferes with the informed consent process (individuals stable on psychiatric medications will be included); or i) Daily or exclusive use of other tobacco products (e.g., electronic cigarettes, little cigars, etc.).


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): NCT03276780


Contacts
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Contact: Karen Cropsey, PsyD 205-975-4204 kcropsey@uabmc.edu
Contact: Michelle Sisson, MA

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Michelle Sisson, M.A.    205-975-7809    msisson2@uab.edu   
Contact: Samantha Schiavon, M.A.    205-975-4528    sschiavon@uabmc.edu   
Principal Investigator: Karen Cropsey, Psy.D.         
Sub-Investigator: Richard Shelton, M.D.         
Sub-Investigator: Peter Hendricks, Ph.D.         
Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: Karen Cropsey, Professor of Psychiatry, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03276780     History of Changes
Other Study ID Numbers: F151019004
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes