Trial Outcomes & Findings for Tobacco Cessation Treatment Preferences Among Veteran Smokers (NCT NCT05277207)
NCT ID: NCT05277207
Last Updated: 2024-05-07
Results Overview
Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Results posted on
2024-05-07
Participant Flow
Participant milestones
| Measure |
MESH
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Personalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
|
Best Practice Telehealth Group
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
SmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tobacco Cessation Treatment Preferences Among Veteran Smokers
Baseline characteristics by cohort
| Measure |
MESH
n=15 Participants
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Personalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
|
Best Practice Telehealth Group
n=15 Participants
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
SmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
59.75 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-treatment 3-month follow-up visit (approximately three months after enrollment)Population: One control participant withdrew prior to the 3-month-follow-up, resulting in 14 control group participants.
Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure.
Outcome measures
| Measure |
MESH
n=15 Participants
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Personalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
|
Best Practice Telehealth Group
n=14 Participants
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
SmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
|
|---|---|---|
|
Number of Participants Who Report Post-treatment Satisfaction
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Post-treatment, approximately eight weeks after baseline visitTreatment attendance is defined as the proportion of participants who complete at least one treatment session (via self-report for control group, via attendance logs for treatment group).
Outcome measures
| Measure |
MESH
n=15 Participants
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Personalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
|
Best Practice Telehealth Group
n=14 Participants
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
SmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
|
|---|---|---|
|
Treatment Attendance
|
15 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Post-treatment 3-month follow-up visit (approximately three months after enrollment)Population: Therapist-rated treatment acceptability was only measured in the active treatment group.
The proportion of post-treatment acceptability scores greater than 3.5 will be reported. Post-treatment therapist acceptability will be measured at the 3-month follow-up. Acceptability will be defined as a mean score greater than 3.5 on the acceptability measure.
Outcome measures
| Measure |
MESH
n=15 Participants
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Personalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
|
Best Practice Telehealth Group
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
SmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
|
|---|---|---|
|
Therapist-rated Treatment Acceptability in Active Treatment Group
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: Post-treatment, approximately eight weeks after baseline visitPopulation: This outcome was only measured in active treatment recipients
The investigators will provide the proportion of participants assigned to the active treatment group who complete treatment.
Outcome measures
| Measure |
MESH
n=15 Participants
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Personalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
|
Best Practice Telehealth Group
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
SmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
|
|---|---|---|
|
Proportion of Participants Who Completed Treatment in the Active Treatment Group
|
100 Percent pts completing treatment
|
—
|
Adverse Events
MESH
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Best Practice Telehealth Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MESH
n=15 participants at risk
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Personalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
Personalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.
Personalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.
|
Best Practice Telehealth Group
n=15 participants at risk
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
SmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
VA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.
Education about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea due to nicotine replacement therapy
|
6.7%
1/15 • Number of events 1 • 6 months
|
0.00%
0/15 • 6 months
|
|
Psychiatric disorders
mood symptoms related to Varenicline use
|
13.3%
2/15 • Number of events 2 • 6 months
|
0.00%
0/15 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place