NCT04020718

Engagement With an Adaptive Mobile Health Smoking Cessation Intervention

Completed Phase 4 Results posted Last updated 10 March 2022

What this trial tests

Phase 4 trial testing Brief telephone advice plus tailored text messages in Tobacco Use Cessation in 35 participants. Completed in 30 November 2020.

Timeline

31 January 2020

Primary endpoint
30 November 2020

30 November 2020

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	31 January 2020
Primary completion	30 November 2020
Estimated completion	30 November 2020
Sites	1 location across United States

Drugs / interventions tested

• Brief telephone advice plus tailored text messages
• Mailed nicotine replacement therapy — full drug profile →
• Proactive telephone coaching

Conditions studied

• Tobacco Use Cessation — all drugs for Tobacco Use Cessation →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Tobacco Use 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 With Self-reported 7-day Abstinence From Smoking at 12 Weeks Primary · 12 weeks post-randomization

7-day point prevalence abstinence (0, abstinent; 1, smoking), measured as "Have you smoked cigarettes, even a puff, in the past seven days?"

0-abstinent

Group	Value	95% CI
Early Assessment Non-responder NRT	0
Early Assessment Non-responder NRT Plus Coaching	1
Early Assessment Responder	1
Late Assessment Non-responder NRT	4
Late Assessment Non-responder NRT Plus Coaching	1
Late Assessment Responder	0

1-smoking

Group	Value	95% CI
Early Assessment Non-responder NRT	8
Early Assessment Non-responder NRT Plus Coaching	4
Early Assessment Responder	1
Late Assessment Non-responder NRT	4
Late Assessment Non-responder NRT Plus Coaching	6
Late Assessment Responder	0

Number of Participants With Self-reported 7-day Abstinence From Smoking at 8 Weeks Secondary · 8 weeks post-randomization

7-day point prevalence abstinence (0, abstinent; 1, smoking)

0-abstinent

Group	Value	95% CI
Early Assessment Non-responder NRT	0
Early Assessment Non-responder NRT Plus Coaching	1
Early Assessment Responder	2
Late Assessment Non-responder NRT	0
Late Assessment Non-responder NRT Plus Coaching	0
Late Assessment Responder	0

1-smoking

Group	Value	95% CI
Early Assessment Non-responder NRT	8
Early Assessment Non-responder NRT Plus Coaching	5
Early Assessment Responder	2
Late Assessment Non-responder NRT	8
Late Assessment Non-responder NRT Plus Coaching	7
Late Assessment Responder	0

Exhaled Carbon Monoxide Less Than 8 Parts Per Million Secondary · 12 weeks post-randomization

Exhaled carbon monoxide measured in parts per million collected at 12 weeks after enrollment

0-no biochemically verified abstinence

Group	Value	95% CI
Early Assessment Non-responder NRT	8
Early Assessment Non-responder NRT Plus Coaching	4
Early Assessment Responder	1
Late Assessment Non-responder NRT	5
Late Assessment Non-responder NRT Plus Coaching	6
Late Assessment Responder	0

1-biochemically verified abstinence

Group	Value	95% CI
Early Assessment Non-responder NRT	0
Early Assessment Non-responder NRT Plus Coaching	1
Early Assessment Responder	1
Late Assessment Non-responder NRT	3
Late Assessment Non-responder NRT Plus Coaching	1
Late Assessment Responder	0

Self-reported Number of Days Nicotine Lozenge and/or Patch Used Secondary · 12 weeks post-randomization

Number of days when patch and/or lozenge was used

Group	Value	95% CI
Mailed 4-week Supply of Combination NRT	5.8	± 2.4
Mailed 4-week Supply of Combination NRT Plus Proactive Telephone Coaching	7.0	± 0.0

Self-reported Change in Average Number of Cigarettes Smoked Per Day Secondary · 12 weeks post-randomization

Self-reported change in average cigarettes smoked per day

Group	Value	95% CI
Early Assessment Non-responder NRT	-7.0	± 7.3
Early Assessment Non-responder NRT Plus Coaching	-7.2	± 7.7
Early Assessment Responder	-13.0	± 9.9
Late Assessment Non-responder NRT	-12.5	± 9.3
Late Assessment Non-responder NRT Plus Coaching	-4.7	± 7.3

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Early Assessment Non-responder NRT

Serious: 0/8 (0%)

Deaths: 0/8

Early Assessment Non-responder NRT Plus Coaching

Serious: 0/5 (0%)

Deaths: 0/5

Early Assessment Responder

Serious: 0/2 (0%)

Deaths: 0/2

Late Assessment Non-responder NRT

Serious: 0/8 (0%)

Deaths: 0/8

Late Assessment Non-responder NRT Plus Coaching

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (4 terms — click to expand)

Reaction	System	Early Assessment Non-respo…	Early Assessment Non-respo…	Early Assessment Responder	Late Assessment Non-respon…	Late Assessment Non-respon…
nausea	Gastrointestinal disorders	—	—	—	—	—
Hiccup	Gastrointestinal disorders	—	—	—	—	—
indigestion	Gastrointestinal disorders	—	—	—	—	—
anxiety	Psychiatric disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT04020718 adverse events section.

Sponsor's own description

This is a pilot sequential multiple assignment trial (SMART) to understand the optimal timing to assess response to our smoking cessation text message intervention and to measure how adding medications alone compares to adding medications and telephone coaching for those who continue to smoke. This study aims to assess the feasibility of a SMART of a proactively offered text message intervention for smokers in primary care that compares early (4 weeks) versus late (8 weeks) assessment of treatment response and the addition of nicotine replacement therapy (NRT) alone or with telephone coaching for non-responders.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Quit Experiences among Primary Care Patients Enrolled in a Smoking Cessation Pilot RCT Early in the COVID-19 Pandemic.
   Joyce AA, Styklunas GM, Rigotti NA, Neil JM, et al · · 2021 · cited 14× · PMID 33498834 · DOI 10.3390/ijerph18031011
2. Abstracts from the 2021 Annual Meeting of the Society of General Internal Medicine.
   · 2021 · cited 11× · PMID 34297318 · DOI 10.1007/s11606-021-06830-5
3. A pilot adaptive trial of text messages, mailed nicotine replacement therapy, and telephone coaching among primary care patients who smoke.
   Kruse GR, Joyce A, Yu L, Park ER, et al · · 2023 · cited 3× · PMID 36880910 · DOI 10.1016/j.josat.2022.208930