Trial Outcomes & Findings for A Text-based Reduction Intervention for Smokeless Tobacco Cessation (NCT NCT04315506)

Last Updated: 2024-07-17

Results Overview

Measured by self-report. Number of participants who replied "no" the following: "In the past 7 days, have you used chew/dip?- Yes or No".

Recruitment status

COMPLETED

Study phase

Target enrollment

532 participants

Primary outcome timeframe

6 months post-randomization

Results posted on

2024-07-17

Participant Flow

All participants recruited for the study using social media and other media advertisement outlets (i.e., Facebook, Instagram, Google Ads). An advertising profile for the study targeted the study population (e.g., smokeless tobacco users (chewer/dipper), over age 18, profiled for tobacco use) for rural and medically underserved counties in the U.S. This was a single- site study, which used electronic consents and survey measures.

Participant milestones

Participant milestones
Measure	#EnufSnuff.TXT Intervention Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use until you reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.	Enough Snuff Intervention Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks.
Overall Study STARTED	264	268
Overall Study COMPLETED	182	177
Overall Study NOT COMPLETED	82	91

Reasons for withdrawal

Reasons for withdrawal
Measure	#EnufSnuff.TXT Intervention Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use until you reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.	Enough Snuff Intervention Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks.
Overall Study Lost to Follow-up	74	82
Overall Study Withdrawal by Subject	8	8
Overall Study Physician Decision	0	1

Baseline Characteristics

A Text-based Reduction Intervention for Smokeless Tobacco Cessation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	#EnufSnuff.TXT Intervention n=264 Participants Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use until you reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.	Enough Snuff Intervention n=268 Participants Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks.	Total n=532 Participants Total of all reporting groups
Age, Continuous	44.8 years STANDARD_DEVIATION 11.9 • n=5 Participants	45.1 years STANDARD_DEVIATION 11.9 • n=7 Participants	44.9 years STANDARD_DEVIATION 11.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	262 Participants n=5 Participants	266 Participants n=7 Participants	528 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	257 Participants n=5 Participants	255 Participants n=7 Participants	512 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	7 Participants n=7 Participants	13 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	257 Participants n=5 Participants	255 Participants n=7 Participants	512 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	264 Participants n=5 Participants	268 Participants n=7 Participants	532 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post-randomization

Measured by self-report. Number of participants who replied "no" the following: "In the past 7 days, have you used chew/dip?- Yes or No".

Outcome measures

Outcome measures
Measure	#EnufSnuff.TXT Intervention n=264 Participants Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use until you reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.	Enough Snuff Intervention n=268 Participants Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks.
Number of Participants Who Did Not Use Chew/Dip in the Past 7 Days (Quit)	61 Participants	56 Participants

SECONDARY outcome

Timeframe: Baseline, 3 months, and 6 months post-randomization

The MNWS is a seven-item scale that measures withdrawal symptoms (i.e., irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia) during the past 24 hours. Each item was measured using a Likert scale (with 0 = not present to 4 = severe). A nicotine withdrawal total score was derived by summing the scores for the 7-items, with a possible range from 0 to 28, and higher scores indicating greater withdrawal.

Outcome measures

Outcome measures
Measure	#EnufSnuff.TXT Intervention n=264 Participants Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use until you reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.	Enough Snuff Intervention n=268 Participants Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks.
Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) Baseline	7.3 score on a scale Standard Deviation 6.3	7.1 score on a scale Standard Deviation 5.7
Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) 3 Months	6.3 score on a scale Standard Deviation 5.2	5.9 score on a scale Standard Deviation 5.4
Change in Withdrawal as Measured by Minnesota Nicotine Withdrawal Scale (MNWS) 6 Months	5.8 score on a scale Standard Deviation 5.8	5.4 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline, 3 months, and 6 months post-randomization

The STEQ is a 12-item scale assessing the degree to which participants experience the reinforcing effects of smokeless tobacco on a 7-point Likert scale (0= not at all to 7=Extremely). The tool has five subscales: chewing satisfaction, psychological reward, enjoyment of sensations in cheek/gum, craving reduction, and aversion. To assess change in craving, the one item craving reduction subscale was used for this analysis. The question was "Did chewing/dipping immediately relieve your craving for smokeless tobacco?". The possible range was 0= not at all to 7=Extremely. At each timepoint, a higher score on this item indicated greater withdrawal symptom in terms of craving relief. Thus, a decrease in the mean craving reduction score across time indicates an improvement in the withdrawal symptoms specific to craving.

Outcome measures

Outcome measures
Measure	#EnufSnuff.TXT Intervention n=264 Participants Scheduled gradual reduction. Participants are asked to gradually reduce smokeless tobacco usage. SGR: The SGR program will reduce smokeless tobacco use until you reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.	Enough Snuff Intervention n=268 Participants Participants in this arm will be given the Enuff Snuff cessation manual. Control: Participants will be sent the Enough Snuff cessation manual. One week after it is sent, participants will then receive text messages from the study team twice a week for ten weeks.
Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) Baseline	5.1 score on a scale Standard Deviation 1.6	5.1 score on a scale Standard Deviation 1.5
Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) 3 Months	5.0 score on a scale Standard Deviation 1.5	4.8 score on a scale Standard Deviation 1.6
Change in Craving as Measured by Smokeless Tobacco Evaluation Questionnaire (STEQ) 6 Months	4.7 score on a scale Standard Deviation 1.6	4.6 score on a scale Standard Deviation 1.7

Adverse Events

#EnufSnuff.TXT Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enough Snuff Intervention

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

Devon Noonan

Duke University

Phone: 919-684-3786

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place