Trial Outcomes & Findings for Testing Integrative Smoking Cessation for HIV Patients (NCT NCT05030766)
NCT ID: NCT05030766
Last Updated: 2025-06-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
95 participants
Primary outcome timeframe
4 weeks (end of treatment), and 3 months
Results posted on
2025-06-04
Participant Flow
Phase 2 participants are participants that did not quit smoking in their respective Phase 1 group, who were then assigned to the opposite group in Phase 2. Phase 1 MT participants who did not quit smoking go to Phase 2 CM, Phase 1 CM participants who did not quit smoking go to Phase 2 MT. Those participants who quit smoking do not get randomized again.
Participant milestones
| Measure |
Mindfulness Training (MT) and NRT (Phase 1)
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 (CM) and NRT (Phase 1)
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Contingency Management Smoking Cessation Intervention: 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.
|
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
|---|---|---|---|---|
|
Phase 1 Participants
STARTED
|
49
|
46
|
0
|
0
|
|
Phase 1 Participants
COMPLETED
|
21
|
15
|
0
|
0
|
|
Phase 1 Participants
NOT COMPLETED
|
28
|
31
|
0
|
0
|
|
Phase 2 Participants
STARTED
|
0
|
0
|
12
|
10
|
|
Phase 2 Participants
COMPLETED
|
0
|
0
|
6
|
8
|
|
Phase 2 Participants
NOT COMPLETED
|
0
|
0
|
6
|
2
|
Reasons for withdrawal
| Measure |
Mindfulness Training (MT) and NRT (Phase 1)
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 (CM) and NRT (Phase 1)
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Contingency Management Smoking Cessation Intervention: 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.
|
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
|---|---|---|---|---|
|
Phase 1 Participants
Lost to Follow-up
|
12
|
22
|
0
|
0
|
|
Phase 1 Participants
Did not attend sessions after being randomized
|
16
|
9
|
0
|
0
|
|
Phase 2 Participants
Lost to Follow-up
|
0
|
0
|
6
|
2
|
Baseline Characteristics
Testing Integrative Smoking Cessation for HIV Patients
Baseline characteristics by cohort
| Measure |
Mindfulness Training (MT) and NRT (Phase 1)
n=49 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 (CM) and NRT (Phase 1)
n=46 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Contingency Management Smoking Cessation Intervention: 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.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.54 years
STANDARD_DEVIATION 8.49 • n=5 Participants
|
51.59 years
STANDARD_DEVIATION 11.63 • n=7 Participants
|
53.07 years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/ Asian American / Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks (end of treatment), and 3 monthsPopulation: Only those who participated in their treatment (completed at least one session).
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.
Outcome measures
| Measure |
Mindfulness Training (MT) and NRT (Phase 1)
n=49 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 (CM) and NRT (Phase 1)
n=46 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Contingency Management Smoking Cessation Intervention: 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.
|
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)
n=12 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)
n=10 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
|---|---|---|---|---|
|
Number of Participants Reporting 7-day Point-prevalence Abstinence
4 weeks (end of treatment)
|
8 participants
|
12 participants
|
3 participants
|
2 participants
|
|
Number of Participants Reporting 7-day Point-prevalence Abstinence
3 months
|
12 participants
|
9 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All participants who enrolled and were randomized.
Treatment specific retention rates reported as the percentage of participants who completed their final 3-month assessment divided by the total of participants enrolled.
Outcome measures
| Measure |
Mindfulness Training (MT) and NRT (Phase 1)
n=49 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 (CM) and NRT (Phase 1)
n=46 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Contingency Management Smoking Cessation Intervention: 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.
|
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)
n=12 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)
n=10 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
|---|---|---|---|---|
|
Retention Rate
|
42.83 percentage of patients
|
32.61 percentage of patients
|
50.00 percentage of patients
|
80.00 percentage of patients
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Includes all participants who were randomized to a treatment arm. Note that Phase 1 and Phase 2 participants are not mutually exclusive (Phase 2 participants come from Phase 1). Mindfulness Training participants did one call per week of treatment, 4 calls in total. Contingency management did 3 calls per week of treatment for a total of 12 calls.
Defined as number of phone-call check-ins attended by each participant (4 for mindfulness training, 12 for contingency management).
Outcome measures
| Measure |
Mindfulness Training (MT) and NRT (Phase 1)
n=49 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 (CM) and NRT (Phase 1)
n=46 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Contingency Management Smoking Cessation Intervention: 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.
|
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)
n=12 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)
n=10 Participants
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.
Nicotine Replacement Therapy: 6 weeks of Nicotine replacement patches
Mindfulness Training Smoking Cessation Intervention: 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 Intervention: 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.
|
|---|---|---|---|---|
|
Treatment Specific Adherence Rates
Less than half the check-ins
|
4 participants
|
21 participants
|
9 participants
|
1 participants
|
|
Treatment Specific Adherence Rates
More than half the check-ins but did not complete all
|
9 participants
|
5 participants
|
2 participants
|
4 participants
|
|
Treatment Specific Adherence Rates
Completed all check-ins
|
16 participants
|
0 participants
|
0 participants
|
4 participants
|
|
Treatment Specific Adherence Rates
0 check-ins
|
18 participants
|
15 participants
|
1 participants
|
0 participants
|
|
Treatment Specific Adherence Rates
Half of the check-ins
|
2 participants
|
5 participants
|
0 participants
|
1 participants
|
Adverse Events
Mindfulness Training (MT) and NRT (Phase 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Contingency Management (CM) and NRT (Phase 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mindfulness Training (MT) and NRT + Additional CM Group (Phase 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Contingency Management (CM) and NRT + Additional MT Group (Phase 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place