Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence

NCT03276780 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: F151019004R34DA043346
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (13)

• Rate of Participant Retention

  Feasibility of the novel NRT intervention was measured by enrolling the targeted sample size of 80 participants. This outcome measure was also measured by the rate of retention of the participants from baseline to the last study visit after 4 months had passed.

  From baseline through 4 months

• Rate of Recruitment

  The acceptability of the novel NRT intervention was measured by calculating the rate of recruitment of study participants during the 56 weeks of active recruitment and intervention for this study.

  56 weeks

• Rate of Enrollment

  The acceptability of the novel NRT intervention was measured by calculating the rate of enrollment of study participants during the 56 weeks of active recruitment and intervention for this study.

  56 weeks

• Treatment Satisfaction

  Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.

  5 weeks

• Treatment Satisfaction

  Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.

  13 weeks

• Treatment Satisfaction

  Treatment satisfaction was measured using the Treatment Satisfaction Survey (TSS), a measure developed in the research lab (i.e. no standardized scoring). The measure included 10 questions about satisfaction with the study treatment that participants rated from 1 (not helpful) to 7 (very helpful). The minimum value for this scale was 10 and the maximum value for this scale was 70, with a total score of 70 indicating greater satisfaction with the study treatment and a score of 10 indicating no satisfaction with the study treatment. Higher scores on this measure indicated better outcomes for the participant since higher scores indicated more satisfaction with the study treatment.

  4 months

• Treatment Expectancies at Baseline

  Treatment expectancies were measured using the Treatment Expectations questionnaire, a measure developed in the research lab (i.e. no standardized scoring). This measure included 8 items assessing how useful participants' believed the study treatment would be in helping them quit smoking. Participants rated items 1-5 on a scale from 1 (not at all helpful) to 7 (very much helpful). For items 1-3, participants chose which study treatment they would recommend the most to a friend (i.e. the nicotine patch, nicotine gum, nicotine inhaler, nicotine nasal spray, nicotine lozenge, or none), which study treatment they would recommend least to a friend, and overall, which study treatment they found to be the most useful. Only items 1-5 were analyzed for outcomes, with 35 as the maximum value and 5 as the minimum value. Higher scores indicated higher participant expectations for the study treatment and higher expectations for their treatment outcome.

  Assessed at baseline

• Treatment Credibility

  Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. Higher scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.

  5 weeks

• Treatment Credibility

  Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.

  13 weeks

• Treatment Credibility

  Treatment credibility was measured using the Credibility and Expectancy Questionnaire (CEQ), which is a standardized measure of treatment credibility and expectancy. CEQ scores were standardized, with the minimum score being -13.5 and the maximum score being 4.43. High scores indicated the participant believed the treatment was more credible and had higher expectations for their treatment outcome.

  4 months

• Number of Participants With Medication Adherence at Week 6

  Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.

  From baseline through 6 weeks

• Number of Participants With Medication Adherence at Week 9

  Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.

  From baseline through 9 weeks

• Number of Participants With Medication Adherence at Week 13

  Medication adherence was assessed through self reports from participants and confirmed with package counts by study staff.

  From baseline through 13 weeks

Study Arms (2)

In vivo

EXPERIMENTAL

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; Drug: combination NRT

Standard of care

ACTIVE COMPARATOR

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; Drug: combination NRT

Interventions

Counseling BEHAVIORAL

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

In vivo; Standard of care

combination NRT DRUG

Both groups will receive combination NRT to help with smoking cessation

In vivo; Standard of care

Eligibility Criteria

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

You may qualify if:

• 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 cigarettes per day (CPD) for the past year and a carbon monoxide (CO) level of less than 8 ppm 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

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

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

• Sisson ML, Gajos JM, Wolford-Clevenger C, Chichester KR, Hawes ES, Hill SV, Shelton RC, Hendricks PS, Businelle MS, Carpenter MJ, Cropsey KL. Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes. J Addict Med. 2024 Jul-Aug 01;18(4):397-403. doi: 10.1097/ADM.0000000000001298. Epub 2024 Mar 6.

  PMID: 38446860 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Karen Cropsey
• Organization: University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology

kcropsey@uabmc.edu

205-975-4204

Study Officials

• Karen Cropsey, PsyD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Model Details: In vivo or standard of care

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: May 3, 2018
• Primary Completion: May 31, 2020
• Study Completion: October 31, 2020
• Last Updated: May 8, 2024
• Results First Posted: December 20, 2021

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)