Tobacco Use Disorder Clinical Trial
Official title:
Abstinence Reinforcement Therapy (ART) for Homeless Veteran Smokers
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02432066 -
Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions
|
Phase 2 | |
Completed |
NCT03960138 -
Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking
|
N/A | |
Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
Completed |
NCT04646668 -
Comparative Abuse Liability Among African American and White Smokers
|
N/A | |
Completed |
NCT02560324 -
Effect of Ramelteon on Smoking Abstinence
|
Phase 2 | |
Completed |
NCT02347605 -
Medicinal Nicotine for Preventing Cue Induced Craving
|
N/A | |
Terminated |
NCT01800500 -
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
|
N/A | |
Completed |
NCT01442753 -
Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth
|
N/A | |
Completed |
NCT01625767 -
Tobacco Approach Avoidance Training for Adolescent Smokers-1
|
Phase 2 | |
Completed |
NCT01570595 -
Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV
|
Phase 1/Phase 2 | |
Completed |
NCT01428310 -
Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke
|
Phase 1 | |
Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
Completed |
NCT01337817 -
A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers
|
Phase 1 | |
Completed |
NCT00967005 -
N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers
|
Phase 2 | |
Active, not recruiting |
NCT00751660 -
Screening Methods in Finding Lung Cancer Early in Current or Former Smokers
|
N/A | |
Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
Completed |
NCT00664261 -
Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking
|
N/A | |
Completed |
NCT01213524 -
Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia
|
Phase 2 | |
Completed |
NCT00158158 -
Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2
|
Phase 2/Phase 3 | |
Completed |
NCT00134927 -
A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches
|
N/A |