Trial Outcomes & Findings for Tobacco Cessation in Public Housing (NCT NCT04889638)

Results Overview

This outcome measures assesses cravings or withdrawal that occurs upon brief cessation of smoking, smoking temptations, compulsive use, and tolerance. The scores range from 8 - 40. The lower end of the range indicates no nicotine dependence and the upper end of the range correlates with a high degree of dependence.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Baseline, 4 weeks

Results posted on

2026-01-22

Participant Flow

Participants were recruited from 2 participating housing units.

Participant milestones

Participant milestones
Measure	Recruitment Arm Each participant was expected to commit to a 4-week study that will be administered both in-person at their housing site and remotely. Remote study visits will occurred by either a video conference call or standard audio phone call. At each session, the following 2 things were discussed: Drug education, proper drug usage and side-effect monitoring of a 4-week supply of nicotine medications that are delivered to participant's home address prior to starting the first study visit. Motivational counseling to help you quit or reduce smoking.
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tobacco Cessation in Public Housing

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cessation Intervention n=18 Participants Participants will undergo pre-/post-comparisons of a personalized, remote smoking cessation intervention composed of two main elements: a) prescription and monitoring of nicotine (e.g., replacement therapy) and/or non-nicotine pharmacotherapies (e.g., varenicline) and b) cessation-centered motivational messaging.
Age, Continuous	51.1 years STANDARD_DEVIATION 7.2 • n=270 Participants
Sex: Female, Male Female	4 Participants n=270 Participants
Sex: Female, Male Male	14 Participants n=270 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=270 Participants
Race (NIH/OMB) Asian	0 Participants n=270 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=270 Participants
Race (NIH/OMB) Black or African American	18 Participants n=270 Participants
Race (NIH/OMB) White	0 Participants n=270 Participants
Race (NIH/OMB) More than one race	0 Participants n=270 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=270 Participants
PROMIS Nicotine Dependence Survey Score	25.3 score on a scale STANDARD_DEVIATION 6.8 • n=270 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks

This outcome measures assesses cravings or withdrawal that occurs upon brief cessation of smoking, smoking temptations, compulsive use, and tolerance. The scores range from 8 - 40. The lower end of the range indicates no nicotine dependence and the upper end of the range correlates with a high degree of dependence.

Outcome measures

Outcome measures
Measure	Cessation Intervention n=18 Participants Participants will undergo pre-/post-comparisons of a personalized, remote smoking cessation intervention composed of two main elements: a) prescription and monitoring of nicotine (e.g., replacement therapy) and/or non-nicotine pharmacotherapies (e.g., varenicline) and b) cessation-centered motivational messaging.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Nicotine Dependence (Short Form 8a) Score	11.2 score on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Baseline, 4 weeks

This outcome measure assesses smokers' tendency to use smoking as a means of coping with negative affect and stress. The scores range from 4 - 20. A score of 4 indicates cigarettes are not being used to cope with life experience and mental health; a maximum of 20 indicates cigarettes are being used always or very much to address both negative life experiences and mental health.

Outcome measures

Outcome measures
Measure	Cessation Intervention n=18 Participants Participants will undergo pre-/post-comparisons of a personalized, remote smoking cessation intervention composed of two main elements: a) prescription and monitoring of nicotine (e.g., replacement therapy) and/or non-nicotine pharmacotherapies (e.g., varenicline) and b) cessation-centered motivational messaging.
Change in PROMIS Coping Expectancies (Short Form 4a) Score	5.2 score on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: Baseline, 4 weeks

This outcome measure assesses perceptions of improved cognitive abilities, positive affective states, and pleasurable sensorimotor sensations due to smoking. The scores range from 6 - 30. A score of 6 indicates cigarettes are not being used to enhance emotional and sensory experiences; a maximum of 30 indicates cigarettes are strongly (or very much) used to improve both emotional and sensory experiences.

Outcome measures

Outcome measures
Measure	Cessation Intervention n=18 Participants Participants will undergo pre-/post-comparisons of a personalized, remote smoking cessation intervention composed of two main elements: a) prescription and monitoring of nicotine (e.g., replacement therapy) and/or non-nicotine pharmacotherapies (e.g., varenicline) and b) cessation-centered motivational messaging.
Change in PROMIS Emotional and Sensory Expectancies (Short Form 6a) Score	7.1 score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline, 4 weeks

This outcome measure assesses perceptions of improved cognitive abilities, positive affective states, and pleasurable sensorimotor sensations due to smoking. The scores range from 6 - 30. A score of 6 indicates smoking cigarettes are not perceived at all as being associated with negative health experiences, including changes in cognition, affect and sensorimotor sensations; a score of 30 translates to a perception that cognition, affect and sensorimotor sensations are very much associated with smoking.

Outcome measures

Outcome measures
Measure	Cessation Intervention n=18 Participants Participants will undergo pre-/post-comparisons of a personalized, remote smoking cessation intervention composed of two main elements: a) prescription and monitoring of nicotine (e.g., replacement therapy) and/or non-nicotine pharmacotherapies (e.g., varenicline) and b) cessation-centered motivational messaging.
Change in PROMIS Health Expectancies (Short Form 6a) Score	6.3 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline, 4 weeks

This outcome measure assesses smokers' beliefs about aspects of social disapproval and disappointment in oneself that are experienced as a result of smoking. The scores range from 6 - 30. A score of 6 indicates smoking cigarettes are not perceived at all as being associated with social disapproval and disappointment in oneself; a score of 30 translates to a perception that smoking is very much associated with social disapproval and disappointment in oneself

Outcome measures

Outcome measures
Measure	Cessation Intervention n=18 Participants Participants will undergo pre-/post-comparisons of a personalized, remote smoking cessation intervention composed of two main elements: a) prescription and monitoring of nicotine (e.g., replacement therapy) and/or non-nicotine pharmacotherapies (e.g., varenicline) and b) cessation-centered motivational messaging.
Change in PROMIS Psychosocial Expectancies (Short Form 6a) Score	5.1 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline, 4 weeks

This outcome measure assesses smokers' assesses self-reported social factors that influence smoking behavior. The range of scores is from 4 - 20. A score of 4 indicates there is not any perceived association between smoking and social factors; a score of 20 indicates a very strong perception that smoking is associated with social factors.

Outcome measures

Outcome measures
Measure	Cessation Intervention n=18 Participants Participants will undergo pre-/post-comparisons of a personalized, remote smoking cessation intervention composed of two main elements: a) prescription and monitoring of nicotine (e.g., replacement therapy) and/or non-nicotine pharmacotherapies (e.g., varenicline) and b) cessation-centered motivational messaging.
Change in PROMIS Social Motivations (Short Form 4a) Score	7.3 score on a scale Standard Deviation 4.3

Adverse Events

Cessation 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

Panagis Galiatsatos, MD, MHS

Johns Hopkins University School of Medicine

Phone: 4104934866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place