SmokingPhase 4NCT05030766
Testing Integrative Smoking Cessation for HIV Patients
A Phase 4 study testing Nicotine Replacement Therapy, Mindfulness Training Smoking Cessation Intervention and Contingency Management Smoking Cessation Intervention in people with Smoking and Smoking Cessation, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Smoking Cessation, HIV Infections
- What is being tested?
- Nicotine Replacement Therapy, Mindfulness Training Smoking Cessation Intervention and Contingency Management Smoking Cessation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 23 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients
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.
- Conditions
- Smoking, Smoking Cessation, HIV Infections
- Being tested
- Nicotine Replacement Therapy, Mindfulness Training Smoking Cessation Intervention, Contingency Management Smoking Cessation Intervention
- Keywords
- Mindfulness Training, Contingency Management
- Medical subject headings
- Smoking, Smoking Cessation, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Replacement TherapyDrug
6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation InterventionBehavioural
Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.
Contingency Management Smoking Cessation InterventionBehavioural
Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.
| Study group | Role | What they receive |
|---|---|---|
| MT plus NRT Group-Phase 1 | Experimental | Participants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention. Receives: Drug: Nicotine Replacement Therapy; Behavioral: Mindfulness Training Smoking Cessation Intervention |
| CM plus NRT Group-Phase1 | Experimental | Participants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention. Receives: Drug: Nicotine Replacement Therapy; Behavioral: Contingency Management Smoking Cessation Intervention |
| MT plus NRT with additional CM Group-Phase2 | Experimental | Participants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks. Receives: Drug: Nicotine Replacement Therapy; Behavioral: Mindfulness Training Smoking Cessation Intervention; Behavioral: Contingency Management Smoking Cessation Intervention |
| CM plus NRT with additional MT Group-Phase2 | Experimental | Participants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks. Receives: Drug: Nicotine Replacement Therapy; Behavioral: Mindfulness Training Smoking Cessation Intervention; Behavioral: Contingency Management Smoking Cessation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting 7-day Point-prevalence Abstinence
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.
Measured: 4 weeks (end of treatment), and 3 months
Secondary outcomes (2)
Retention Rate
Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.
Measured: 3 months
Treatment Specific Adherence Rates
Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start4 Jan 2022
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghrid Asfar, University of Miami
- Investigators
- Taghrid A. Asfar, MD, MSPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030766
- Sponsor's protocol ID
- 20201296
- Status last verified
- May 2025
- First submitted
- 26 Aug 2021
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot SMART Pre- and Post-testing of an Integrative Mindfulness-Based Smoking Cessation Intervention for HIV Patients
- ClinicalTrials.gov ID
- NCT05030766
- Acronym / sponsor ID
- 20201296
- Conditions
- Smoking, Smoking Cessation, HIV Infections
- Keywords
- Mindfulness Training, Contingency Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Posted 4 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MT plus NRT Group-Phase 1 | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: Mindfulness Training Smoking Cessation InterventionParticipants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention. |
| CM plus NRT Group-Phase1 | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: Contingency Management Smoking Cessation InterventionParticipants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention. |
| MT plus NRT with additional CM Group-Phase2 | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: Mindfulness Training Smoking Cessation Intervention, Behavioral: Contingency Management Smoking Cessation InterventionParticipants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks. |
| CM plus NRT with additional MT Group-Phase2 | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: Mindfulness Training Smoking Cessation Intervention, Behavioral: Contingency Management Smoking Cessation InterventionParticipants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Replacement Therapy6 weeks of Nicotine replacement patches | Drug | CM plus NRT Group-Phase1, CM plus NRT with additional MT Group-Phase2, MT plus NRT Group-Phase 1, MT plus NRT with additional CM Group-Phase2 |
| Mindfulness Training Smoking Cessation InterventionMindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions. | Behavioural | CM plus NRT with additional MT Group-Phase2, MT plus NRT Group-Phase 1, MT plus NRT with additional CM Group-Phase2 |
| Contingency Management Smoking Cessation InterventionContingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom. | Behavioural | CM plus NRT Group-Phase1, CM plus NRT with additional MT Group-Phase2, MT plus NRT with additional CM Group-Phase2 |
Primary outcome
Number of Participants Reporting 7-day Point-prevalence Abstinence
Time frame: 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.
2 secondary outcomes
Retention Rate
Time frame: 3 months
Treatment Specific Adherence Rates
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Smoking
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taghrid A. Asfar, MD, MSPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine Replacement Therapy, Mindfulness Training Smoking Cessation Intervention and Contingency Management Smoking Cessation Intervention in people with Smoking and Smoking Cessation, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting 7-day Point-prevalence Abstinence (time frame: 4 weeks (end of treatment), and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.