Trial Outcomes & Findings for iQuit Mindfully: Text Messaging for Smoking Cessation (NCT NCT03029819)
NCT ID: NCT03029819
Last Updated: 2019-01-08
Results Overview
Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide \<6 parts per million (ppm)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
End of Treatment (8 weeks)
Results posted on
2019-01-08
Participant Flow
Participant milestones
| Measure |
Mindfulness-based Addiction Treatment (MBAT)
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
iQuit Mindfully
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
39
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Mindfulness-based Addiction Treatment (MBAT)
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
iQuit Mindfully
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Removed due to disruptive behavior
|
0
|
1
|
Baseline Characteristics
iQuit Mindfully: Text Messaging for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Mindfulness-based Addiction Treatment (MBAT)
n=33 Participants
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
iQuit Mindfully
n=38 Participants
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
45.6 Years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
45.6 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
68 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Baseline cigarettes per day
|
18.8 Cigarettes per day
STANDARD_DEVIATION 9.3 • n=5 Participants
|
14.4 Cigarettes per day
STANDARD_DEVIATION 9.4 • n=7 Participants
|
16.5 Cigarettes per day
STANDARD_DEVIATION 9.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: End of Treatment (8 weeks)Population: Available data for smoking abstinence were analyzed because coding missing data as smoking can severely bias results. Accordingly, the overall number of participants analyzed for smoking abstinence was 55.
Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide \<6 parts per million (ppm)
Outcome measures
| Measure |
Mindfulness-based Addiction Treatment (MBAT)
n=24 Participants
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
iQuit Mindfully
n=31 Participants
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
|---|---|---|
|
Smoking Abstinence
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Over the 8-week treatment periodPopulation: Only participants in the iQuit Mindfully condition were included in this analysis because MBAT participants did not receive text messages.
Number of participants who respond to interactive text messages
Outcome measures
| Measure |
Mindfulness-based Addiction Treatment (MBAT)
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
iQuit Mindfully
n=38 Participants
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
|---|---|---|
|
Participant Engagement
|
—
|
34 Participants
|
SECONDARY outcome
Timeframe: End of Treatment (8 weeks)Population: Only participants in the iQuit Mindfully condition were included in this analysis because those in MBAT did not receive text messages.
Perceived Text Message Helpfulness (minimum value 1 \["not at all helpful"\], maximum value 10 \["extremely helpful"\], higher scores mean better outcome)
Outcome measures
| Measure |
Mindfulness-based Addiction Treatment (MBAT)
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
iQuit Mindfully
n=38 Participants
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
|---|---|---|
|
Participant Ratings
|
—
|
8.0 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: End of treatment (8 weeks)Number of participants who do not attend end-of-treatment session
Outcome measures
| Measure |
Mindfulness-based Addiction Treatment (MBAT)
n=33 Participants
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
iQuit Mindfully
n=38 Participants
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
|---|---|---|
|
Attrition
|
9 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: End of treatment (8 weeks)Self-reported number of cigarettes smoked per day (questionnaire)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Throughout treatment period (8 weeks)Self-reported average weekly mindfulness practice (questionnaire)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: End of treatment (8 weeks)Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)
Outcome measures
Outcome data not reported
Adverse Events
Mindfulness-based Addiction Treatment (MBAT)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
iQuit Mindfully
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mindfulness-based Addiction Treatment (MBAT)
n=33 participants at risk
Nicotine patch; self-help guide; MBAT
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
|
iQuit Mindfully
n=39 participants at risk
Nicotine patch; self-help guide; MBAT; text messaging
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
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|---|---|---|
|
General disorders
Mild nicotine patch side effects
|
21.2%
7/33 • Reported over the period of treatment (8 weeks) and 1 month follow-up, for a total of 12 weeks.
|
12.8%
5/39 • Reported over the period of treatment (8 weeks) and 1 month follow-up, for a total of 12 weeks.
|
Additional Information
Claire Spears
Georgia State University School of Public Health
Phone: 4044139335
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place