A Phase 4 interventional study of Nicotine Patches and mobile contingency management (mCM) in Tobacco Use Disorder and Homelessness, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-01-04.
Sponsored by VA Office of Research and Development · Phase 4, Interventional, and Treatment
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.
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 133 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Behavioral: mobile contingency management (mCM) · Behavioral: Smoking cessation counseling · Drug: Nicotine rescue method · Drug: Bupropion
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 · Behavioral: Smoking cessation counseling · Drug: Nicotine rescue method · Drug: Bupropion
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.
Also known as: Nicoderm
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.
Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
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.
Also known as: Nicorette
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.
Also known as: Zyban, Wellbutrin
Number of Participants Self-reported and Bioverified Abstinent From 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).
Time frame: 6 months
Intervention Delivery Costs
Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.
Time frame: 6 months
| Milestone | Abstinence Reinforcement Therapy | Control Group |
|---|---|---|
| Started | 63 | 64 |
| Completed | 63 | 64 |
| Not completed | 0 | 0 |
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).
| Participants | Abstinence Reinforcement Therapy | Control Group |
|---|---|---|
| Number of Participants Self-reported and Bioverified Abstinent From Smoking | 13 | 5 |
Intervention delivery costs (including medication costs, supplies, and incentive pay for abstinence) will be evaluated for treatment and control group.
| dollars | Abstinence Reinforcement Therapy | Control Group |
|---|---|---|
| Intervention Delivery Costs | 618.35 ± 180.02 | 226.00 ± 0 |
Collected over Adverse event data were collected over a one year period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abstinence Reinforcement Therapy | 0/63 (0%) | 0/63 (0%) | 15/63 (23.8%) |
| Control Group | 0/64 (0%) | 1/64 (1.6%) | 18/64 (28.1%) |
| Event | Abstinence Reinforcement Therapy | Control Group |
|---|---|---|
| High blood pressureCardiac disorders | 0/63 | 1/64 |
| Event | Abstinence Reinforcement Therapy | Control Group |
|---|---|---|
| Skin irritation or rashSkin and subcutaneous tissue disorders | 6/63 | 10/64 |
| Nausea or upset stomachGastrointestinal disorders | 3/63 | 3/64 |
| Sleep difficulties or nightmaresGeneral disorders | 3/63 | 3/64 |
| HeadacheNervous system disorders | 3/63 | 2/64 |
| Age, Continuous(years) | Abstinence Reinforcement Therapy | Control Group | Total |
|---|---|---|---|
| Mean | 53.76 ± 10.26 | 55.72 ± 7.49 | 54.75 ± 8.99 |
| Sex: Female, Male(Participants) | Abstinence Reinforcement Therapy | Control Group | Total |
|---|---|---|---|
| Female | 6 | 3 | 9 |
| Male | 57 | 61 | 118 |
| Ethnicity (NIH/OMB)(Participants) | Abstinence Reinforcement Therapy | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 2 | 4 |
| Not Hispanic or Latino | 60 | 62 | 122 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Abstinence Reinforcement Therapy | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 39 | 44 | 83 |
| White | 17 | 11 | 28 |
| More than one race | 7 | 7 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Abstinence Reinforcement Therapy | Control Group | Total |
|---|---|---|---|
| United States | 63 | 64 | 127 |
| Bioverified abstinent from smoking(Participants) | Abstinence Reinforcement Therapy | Control Group | Total |
|---|---|---|---|
| Count of participants | 63 | 64 | 127 |
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