Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02245308
• Collaborator: (none)
• Enrollment: 133
• Location: 1
• Arms: 2
• Actual Duration (Months): 47.9
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

The goal of this research study is to examine the effects of a treatment for helping homeless veterans who smoke to stop smoking. Participants in the study will be assigned to one of two study groups. Participants in the first group will be referred to the local Department of Veterans Affairs Medical Center's Smoking Cessation Clinic for treatment. Second group participants will receive a behavioral treatment designed to reward smokers for quitting and staying quit. These participants will also receive telephone counseling and medications for smoking cessation.

Condition or Disease	Intervention/Treatment	Phase
Tobacco Use Disorder; Homelessness	Drug: Nicotine Patches; Behavioral: mobile contingency management (mCM); Behavioral: Smoking cessation counseling; Drug: Nicotine rescue method; Drug: Bupropion	Phase 4

Detailed Description

Cigarette smoking is the most lethal substance use disorder in the United States in terms of morbidity and mortality. Veterans who are homeless, along with those who have mental health or substance abuse problems, are at the highest risk for nicotine dependence. Prevalence estimates for smoking among homeless Veterans are 80%. Thus, homeless Veterans are at tremendous risk for smoking related morbidity and mortality. This information suggests that smoking needs to be targeted specifically among this high risk population of smokers.

The addition of contingency management (CM) to existing evidence-based tele-health smoking cessation interventions is expected to be a cost-effective way to increase the reach of intensive smoking cessation treatment. CM is a behavioral therapy that provides positive reinforcers to individuals misusing substances contingent upon objective evidence of abstinence from substance use. Because CM requires verification of abstinence multiple times daily with a clinic-based carbon monoxide (CO) monitor, it has largely been relegated to inpatient and day treatment programs. The application of emerging smart phone technology, however, can overcome this barrier, and may be particularly well suited to homeless Veterans. The innovative smart phone application has made the use of CM for outpatient smoking cessation portable and feasible. The goal of this comparative effectiveness trial is to evaluate the effectiveness of a combined tele-health and mobile CM intervention that the investigators are calling Abstinence Reinforcement Therapy (ART). The investigators propose to screen 165 and randomize 126 homeless Veteran smokers to either:

ABSTINENCE REINFORCEMENT THERAPY (ART), a tele-health intervention that combines guideline-based cognitive-behavioral telephone (CBT) counseling, a tele-medicine clinic for access to smoking cessation aids including choice of pharmacotherapy, and intensive behavioral therapy through mCM.

VA SPECIALTY SMOKING CESSATION TREATMENT control, which includes all the elements associated with enrollment in a VA specialty smoking cessation clinic including group counseling, individual telephone counseling, self-help materials, and smoking cessation aids including choice of pharmacotherapy.

Specific aims are to:

AIM 1: Evaluate the impact of ART on rates of abstinence from cigarettes as measured by bio-verified, self-reported prolonged abstinence at post-treatment, and 3-month and 6-month post-randomization follow-ups.

AIM 2: Evaluate the relative cost-effectiveness of the ART intervention in quality adjusted life years (QALY).

AIM 3: Evaluate potential treatment mediators including self-efficacy-related mechanisms.

Supplementary AIM: To evaluate the impact of psychiatric (i.e., PTSD, depression and alcohol abuse) symptoms on treatment outcome across the two conditions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 133 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers
• Actual Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Mar 30, 2018
• Actual Study Completion Date: Sep 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ART Participants assigned to this treatment arm will receive a tele-health intervention that combines guideline-based cognitive-behavioral counseling for smoking cessation, a tele-medicine clinic for access to smoking cessation aids, and an intensive behavioral therapy for smoking cessation called mobile contingency management.	Drug: Nicotine Patches; Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.; Other Names: Nicoderm ; Behavioral: mobile contingency management (mCM); Mobile contingency management (mCM) is 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. Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.; Behavioral: Smoking cessation counseling; Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.; Drug: Nicotine rescue method; Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.; Other Names: Nicorette ; Drug: Bupropion; Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.; Other Names: Zyban, Wellbutrin
Active Comparator: 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.	Drug: Nicotine Patches; Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.; Other Names: Nicoderm ; Behavioral: Smoking cessation counseling; Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.; Drug: Nicotine rescue method; Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.; Other Names: Nicorette ; Drug: Bupropion; Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.; Other Names: Zyban, Wellbutrin

Outcome Measures

Primary Outcome Measures

1. Number of Participants Self-reported and Bioverified Abstinent From Smoking [6 months]

   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).

Secondary Outcome Measures

1. Intervention Delivery Costs [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Veteran

• Homeless

• Enrolled in Durham VA Medical Center for medical care

• Current smoker (at least 10 cigarettes per day)

• Willing to quit smoking in the next 30 days

Exclusion Criteria:

• Active substance dependence other than nicotine

• Uncontrolled psychotic symptoms

• Severely impaired hearing or speech (must be able to respond to telephone calls)

• Lack of interest in receiving telephone care

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Durham VA Medical Center, Durham, NC	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• VA Office of Research and Development

Investigators

• Principal Investigator: Jean C Beckham, PhD, Durham VA Medical Center, Durham, NC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 21, 2017

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02245308
• Other Study ID Numbers: D1301-R; 1828
• First Posted: Sep 19, 2014
• Last Update Posted: Jan 4, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: Tobacco use cessation; Homelessness; Veterans
• Additional relevant MeSH terms: Tobacco Use Disorder; Bupropion; Nicotine

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Abstinence Reinforcement Therapy	Control Group
Arm/Group Description	Participants assigned to this treatment arm will receive a tele-health intervention that combines: 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. 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. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	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.
Period Title: Overall Study
STARTED	63	64
COMPLETED	63	64
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Abstinence Reinforcement Therapy	Control Group	Total
Arm/Group Description	Participants assigned to this treatment arm will receive a tele-health intervention that combines: 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. 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. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	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 of all reporting groups
Overall Participants	63	64	127
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.76 (10.26)	55.72 (7.49)	54.75 (8.99)
Sex: Female, Male (Count of Participants)
Female	6 9.5%	3 4.7%	9 7.1%
Male	57 90.5%	61 95.3%	118 92.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.2%	2 3.1%	4 3.1%
Not Hispanic or Latino	60 95.2%	62 96.9%	122 96.1%
Unknown or Not Reported	1 1.6%	0 0%	1 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	2 3.1%	2 1.6%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	39 61.9%	44 68.8%	83 65.4%
White	17 27%	11 17.2%	28 22%
More than one race	7 11.1%	7 10.9%	14 11%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	63 100%	64 100%	127 100%
Bioverified abstinent from smoking (Count of Participants)
Count of Participants [Participants]	63 100%	64 100%	127 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Self-reported and Bioverified Abstinent From Smoking
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Abstinence Reinforcement Therapy	Control Group
Arm/Group Description	Participants assigned to this treatment arm will receive a tele-health intervention that combines: 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. 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. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	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.
Measure Participants	63	64
Count of Participants [Participants]	13 20.6%	5 7.8%

2. Secondary Outcome

Title	Intervention Delivery Costs
Description	Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Abstinence Reinforcement Therapy	Control Group
Arm/Group Description	Participants assigned to this treatment arm will receive a tele-health intervention that combines: 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. 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. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.	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.
Measure Participants	63	64
Mean (Standard Deviation) [dollars]	618.35 (180.02)	226.00 (0)

Adverse Events

Time Frame	Adverse event data were collected over a one year period.
Adverse Event Reporting Description	clinicaltrials.gov definitions were used.
Arm/Group Title	Abstinence Reinforcement Therapy		Control Group
Arm/Group Description	Participants assigned to this treatment arm will receive a tele-health intervention that combines: 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. 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. Smoking cessation counseling, a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary. Bupropion SR, may be prescribed to medically eligible ART group participants beginning one week prior to quit date.		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.
All Cause Mortality
	Abstinence Reinforcement Therapy		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/64 (0%)
Serious Adverse Events
	Abstinence Reinforcement Therapy		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		1/64 (1.6%)
Cardiac disorders
High blood pressure	0/63 (0%)	0	1/64 (1.6%)	1
Other (Not Including Serious) Adverse Events
	Abstinence Reinforcement Therapy		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/63 (23.8%)		18/64 (28.1%)
Gastrointestinal disorders
Nausea or upset stomach	3/63 (4.8%)	3	3/64 (4.7%)	3
General disorders
Sleep difficulties or nightmares	3/63 (4.8%)	3	3/64 (4.7%)	3
Nervous system disorders
Headache	3/63 (4.8%)	4	2/64 (3.1%)	2
Skin and subcutaneous tissue disorders
Skin irritation or rash	6/63 (9.5%)	8	10/64 (15.6%)	15

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.