Trial Outcomes & Findings for Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers (NCT NCT02245308)

NCT ID: NCT02245308

Last Updated: 2022-01-04

Results Overview

Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 133 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-01-04

Participant Flow

Five participants who signed consent were ineligible to participate in the study because they didn't meet basic eligibility criteria. One participant who signed consent was not randomized to treatment because he was unwilling to stop marijuana use prior to participating.

Participant milestones

Measure	Abstinence Reinforcement Therapy Participants assigned to this treatment arm will receive a tele-health intervention that combines: 1. Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date. 2. Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence. 3. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. 4. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	Control Group Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Overall Study STARTED	63	64
Overall Study COMPLETED	63	64
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers

Baseline characteristics by cohort

Measure	Abstinence Reinforcement Therapy n=63 Participants Participants assigned to this treatment arm will receive a tele-health intervention that combines: 1. Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date. 2. Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence. 3. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. 4. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	Control Group n=64 Participants Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.	Total n=127 Participants Total of all reporting groups
Age, Continuous	53.76 years STANDARD_DEVIATION 10.26 • n=5 Participants	55.72 years STANDARD_DEVIATION 7.49 • n=7 Participants	54.75 years STANDARD_DEVIATION 8.99 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	61 Participants n=7 Participants	118 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants n=5 Participants	62 Participants n=7 Participants	122 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	39 Participants n=5 Participants	44 Participants n=7 Participants	83 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	63 Participants n=5 Participants	64 Participants n=7 Participants	127 Participants n=5 Participants
Bioverified abstinent from smoking	63 Participants n=5 Participants	64 Participants n=7 Participants	127 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants who were randomized to treatment were included in the final analysis of bioverified abstinence, using an intent-to-treat sample where missing = smoking

Smoking abstinence at six months will be measured by self-report and bio-verified by salivary cotinine (a by-product of nicotine found in saliva).

Outcome measures

Measure	Abstinence Reinforcement Therapy n=63 Participants Participants assigned to this treatment arm will receive a tele-health intervention that combines: 1. Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date. 2. Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence. 3. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. 4. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	Control Group n=64 Participants Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Number of Participants Self-reported and Bioverified Abstinent From Smoking	13 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 months

Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.

Outcome measures

Measure	Abstinence Reinforcement Therapy n=63 Participants Participants assigned to this treatment arm will receive a tele-health intervention that combines: 1. Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date. 2. Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence. 3. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. 4. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	Control Group n=64 Participants Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Intervention Delivery Costs	618.35 dollars Standard Deviation 180.02	226.00 dollars Standard Deviation 0

Adverse Events

Abstinence Reinforcement Therapy

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Control Group

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Abstinence Reinforcement Therapy n=63 participants at risk Participants assigned to this treatment arm will receive a tele-health intervention that combines: 1. Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date. 2. Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence. 3. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. 4. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	Control Group n=64 participants at risk Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Cardiac disorders High blood pressure	0.00% 0/63 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.	1.6% 1/64 • Number of events 1 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.

Other adverse events

Measure	Abstinence Reinforcement Therapy n=63 participants at risk Participants assigned to this treatment arm will receive a tele-health intervention that combines: 1. Nicotine replacement therapy in the form of nicotine patches and nicotine replacement therapy in the form of nicotine gum or lozenges provided beginning on the smoking quit date. 2. Mobile contingency management (mCM), a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings, and are reinforced for readings suggesting abstinence. 3. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. 4. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	Control Group n=64 participants at risk Participants assigned to this active control arm will be referred to VA Specialty Smoking Cessation Clinic for standard-of-care treatment, which may include group counseling, individual counseling, self-help materials, and smoking cessation aids.
Gastrointestinal disorders Nausea or upset stomach	4.8% 3/63 • Number of events 3 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.	4.7% 3/64 • Number of events 3 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.
Skin and subcutaneous tissue disorders Skin irritation or rash	9.5% 6/63 • Number of events 8 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.	15.6% 10/64 • Number of events 15 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.
General disorders Sleep difficulties or nightmares	4.8% 3/63 • Number of events 3 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.	4.7% 3/64 • Number of events 3 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.
Nervous system disorders Headache	4.8% 3/63 • Number of events 4 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.	3.1% 2/64 • Number of events 2 • Adverse event data were collected over a one year period. clinicaltrials.gov definitions were used.

Additional Information

Angela Kirby

Durham VA Health Care System

Phone: 919-286-0411

Email: angela.kirby@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place