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Phase 4 Completed N=80 Randomized Treatment

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

Source: ClinicalTrials.gov NCT03276780 ↗
Enrolled (actual)
80
Serious AEs
2.5%
Results posted
Dec 2021
Primary outcomePrimary: Rate of Participant Retention — 23; 29; 18; 10 Participants
◆ Published Evidence
Not yet cited
0citations
Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.
Journal of addiction medicine · 2024 · Open access · Likely link

Summary

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

Linked Publications

  • Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.
    Journal of addiction medicine · 2024 · 0 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Rate of Participant Retention
23; 29; 18; 10
PRIMARY
Rate of Recruitment
5.84
PRIMARY
Rate of Enrollment
1.43
PRIMARY
Treatment Satisfaction
66.35; 65.62
PRIMARY
Treatment Satisfaction
66.35; 65.62
PRIMARY
Treatment Satisfaction
66.35; 65.62
PRIMARY
Treatment Expectancies at Baseline
23.29; 21.23
PRIMARY
Treatment Credibility
-0.26; -1.64
PRIMARY
Treatment Credibility
-0.26; -1.64
PRIMARY
Treatment Credibility
-0.26; -1.64
PRIMARY
Number of Participants With Medication Adherence at Week 6
22; 26; 23; 27
PRIMARY
Number of Participants With Medication Adherence at Week 9
23; 24; 26; 33
PRIMARY
Number of Participants With Medication Adherence at Week 13
18; 21; 17; 22

Eligibility Criteria

Inclusion Criteria

a) 18 years or older; b) qualifying as low income (as defined by making 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.).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03276780) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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