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Phase 4 N=95 Randomized Other

Testing Integrative Smoking Cessation for HIV Patients

Smoking · Smoking Cessation · HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT05030766 ↗
Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Number of Participants Reporting 7-day Point-prevalence Abstinence — 8; 12; 3; 2 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Nicotine Replacement Therapy (Drug); Mindfulness Training Smoking Cessation Intervention (Behavioral); Contingency Management Smoking Cessation Intervention (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Miami
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Reporting 7-day Point-prevalence Abstinence		 8; 12; 3; 2; 12; 9 —
SECONDARY
Retention Rate		 42.83; 32.61; 50.00; 80.00 —
SECONDARY
Treatment Specific Adherence Rates		 18; 15; 1; 0; 4; 21 —

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with HIV (based on self-report).
  • Be 18 years and older
  • Have smoked ≥ 5 cigarettes/day in the past year
  • Be interested in making a quit attempt in the next 30 days
  • Own a smartphone (apple/android), and plan to keep it active for the next 6 months
  • Able to consent
  • Have no plans to move in the next 6 months
  • Are not pregnant or planning to be pregnant in the following 6 months
  • Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Exclusion Criteria

  • Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
  • Are currently being treated for a psychiatric condition.
  • Are currently being treated for smoking cessation, alcoholism, or illicit drug use
  • Are adults unable to consent
  • Are individuals who are not yet adults
  • Are pregnant women
  • Are prisoners
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05030766). 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.

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