NCT05030766 is a Phase 4 clinical trial of Nicotine Replacement Therapy in Smoking, sponsored by University of Miami.

Who is sponsoring NCT05030766?

NCT05030766 is sponsored by University of Miami.

What drugs are being tested in NCT05030766?

Interventions in NCT05030766: Nicotine Replacement Therapy, Mindfulness Training Smoking Cessation Intervention, Contingency Management Smoking Cessation Intervention.

What condition does NCT05030766 study?

NCT05030766 studies Smoking, Smoking Cessation, HIV Infections.

Is NCT05030766 still recruiting?

NCT05030766 is currently completed. Last updated 4 June 2025.

Are results published for NCT05030766?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-06-04 · How we verify

NCT05030766

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Testing Integrative Smoking Cessation for HIV Patients

Completed Phase 4 Results posted Last updated 4 June 2025

What this trial tests

Phase 4 trial testing Nicotine Replacement Therapy in Smoking in 95 participants. Completed in 23 May 2024.

Timeline

4 January 2022

Primary endpoint
23 May 2024

23 May 2024

Quick facts

Lead sponsor	University of Miami
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	other
Enrollment	95
Start date	4 January 2022
Primary completion	23 May 2024
Estimated completion	23 May 2024
Sites	1 location across United States

Drugs / interventions tested

Nicotine Replacement Therapy — full drug profile →
Mindfulness Training Smoking Cessation Intervention
Contingency Management Smoking Cessation Intervention

Conditions studied

Smoking — all drugs for Smoking →
Smoking Cessation — all drugs for Smoking Cessation →
HIV Infections — all drugs for HIV Infections →

Sponsor

University of Miami

Who can join

18 and older, any sex, with Smoking or Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Reporting 7-day Point-prevalence Abstinence Primary · 4 weeks (end of treatment), and 3 months

Defined as self-report of not smoking in the past 7-days, not even a puff and confirmed by expired carbon monoxide (CO) level cutoff of \< 8 ppm using a coVita iCO™ Smokerlyzer® and/or NicoTests saliva sample of ≤ 30 ng/mL.

4 weeks (end of treatment)

Group	Value	95% CI
Mindfulness Training (MT) and NRT (Phase 1)	8
Contingency Management (CM) and NRT (Phase 1)	12
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)	3
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)	2

3 months

Group	Value	95% CI
Mindfulness Training (MT) and NRT (Phase 1)	12
Contingency Management (CM) and NRT (Phase 1)	9
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)	1
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)	2

Retention Rate Secondary · 3 months

Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.

Group	Value	95% CI
Mindfulness Training (MT) and NRT (Phase 1)	42.83
Contingency Management (CM) and NRT (Phase 1)	32.61
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)	50.00
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)	80.00

Treatment Specific Adherence Rates Secondary · 3 months

Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).

0 check-ins

Group	Value	95% CI
Mindfulness Training (MT) and NRT (Phase 1)	18
Contingency Management (CM) and NRT (Phase 1)	15
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)	1
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)	0

Less than half the check-ins

Group	Value	95% CI
Mindfulness Training (MT) and NRT (Phase 1)	4
Contingency Management (CM) and NRT (Phase 1)	21
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)	9
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)	1

Half of the check-ins

Group	Value	95% CI
Mindfulness Training (MT) and NRT (Phase 1)	2
Contingency Management (CM) and NRT (Phase 1)	5
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)	0
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)	1

More than half the check-ins but did not complete all

Group	Value	95% CI
Mindfulness Training (MT) and NRT (Phase 1)	9
Contingency Management (CM) and NRT (Phase 1)	5
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)	2
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)	4

Completed all check-ins

Group	Value	95% CI
Mindfulness Training (MT) and NRT (Phase 1)	16
Contingency Management (CM) and NRT (Phase 1)	0
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)	0
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)	4

Sponsor's own description

The purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with Mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among HIV patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Interventions for tobacco use cessation in people living with HIV.
Mdege ND, Shah S, Dogar O, Pool ER, et al · · 2024 · cited 6× · PMID 39101506 · DOI 10.1002/14651858.cd011120.pub3

Verify or expand the search:

Other trials of Nicotine Replacement Therapy

Trials testing the same drug.

NCT06063421 — Comparison of Nicotine Replacement Therapy and Electronic Cigarettes for Smoking Cessation in Pakistan · NA · unknown
NCT05628389 — Phone Enabled Implementation of Cessation Support · NA · recruiting
NCT04965181 — Mindfulness-based Smoking Cessation Enhanced With Mobile Technology · NA · completed
NCT04590404 — Metabolism Informed Smoking Treatment: The MIST RCT · Phase 3 · completed
NCT04063267 — Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder · Phase 2 · completed

Other recruiting trials for Smoking

Currently open trials in the same condition.

NCT07488741 — Comparison of the Effects of Different Chest Techniques on University Students With Smoking Addiction · NA · recruiting
NCT07443631 — Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants · NA · recruiting
NCT07132814 — Abuse Liability for Five Modern Oral Nicotine Products · NA · recruiting
NCT06966258 — Inspire HER: Inspiring the Heart and Emotions for Radical Health · NA · recruiting
NCT06713603 — Technology Assisted Motivational Interviewing · NA · recruiting

Other University of Miami trials

Trials by the same sponsor.

NCT06003712 — Exploring the Effect of Mindfulness on Quality of Life (QoL) in Spinal Cord Injury (SCI) · NA · not yet recruiting
NCT06077071 — MRIdian "RADAR" Trial · NA · not yet recruiting
NCT07472413 — Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project · Phase 3 · not yet recruiting
NCT07322289 — Antibiotic-coated Braided Suture Study · NA · not yet recruiting
NCT07469592 — eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05030766 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 4 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05030766.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing