Treatment Trials

74 Clinical Trials for Various Conditions

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RECRUITING
Improving Smoking Abstinence Outcomes in the African American Community Through Extended Treatment
Description

This study will evaluate the efficacy of extended bupropion(6 months) versus standard bupropion treatment (7 weeks) among African American daily smokers.

ACTIVE_NOT_RECRUITING
Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)
Description

The goal of this research study is to compare the efficacy of a treatment approach that comprises both Motivation And Problem-Solving (MAPS)-based telephone counseling and a personally-tailored SMS-delivered text-based approach to quitline-delivered smoking cessation treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.

COMPLETED
BRP1802 Smoking Abstinence Study
Description

A single-center study designed to evaluate changes in short-term biomarkers of potential harm (BoPH) in healthy adult cigarette smokers of two age groups (Group A: 24-34 years; Group B: 35-60 years) during 14 days of smoking abstinence.

RECRUITING
Contingency Management to Promote Smoking Abstinence in Cancer Patients
Description

This is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.

COMPLETED
Pilot Trial of Using SmokeBeat to Monitor and Increase Smoking Abstinence in Pregnant Women
Description

Investigators will assess the feasibility of implementing a randomized control trial of a behavioral intervention that uses smartwatch technology to monitor smoking behavior with texts aimed at reducing smoking in pregnant women who smoke. Investigators will compare the cessation rate of pregnant women who receive usual care through programs aimed at reducing smoking with pregnant women who receive usual care and are using the SmokeBeat app with a smartwatch.

COMPLETED
In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence
Description

This is a study to determine the efficacy of a smoking cessation intervention (nicotine replacement therapy (NRT) and counseling) done in a systematized manner with participants recruited from the UAB Substance Abuse Program. The definition of In Vivo experience is: use of the NRT medication during the session using specialized counseling focused around their experience of using NRT, including how the use of NRT may help them quit smoking, side effects, and smoking cessation expectancies. In this study those in the In Vivo group will put the patch on during Session 1 and given nicotine gum in Session 2 and will discuss the experience of wearing the patch or chewing the gum while they are in session. The control group will not put on the patch or chew gum during the sessions but will be given standard counseling regarding quitting smoking.

COMPLETED
Effect of Ramelteon on Smoking Abstinence
Description

This is a randomized, double-blind, placebo-controlled crossover study to test whether a medication called ramelteon (Brand Name: Remeron) will help smokers quit and whether it reduces sleep problems that smokers experience during a quit attempt.

COMPLETED
Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
Description

The purpose of this study is to develop and test a web-based game called Quit It that is designed to help smokers who have quit smoking cope with any smoking urges they may have. The purpose of the game is to help people quit and stop people from smoking again.

COMPLETED
Quit IT: Development of a Web-based, 3D Coping Skills Game to Increase Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
Description

The purpose of this study is to test a web-based video game to help cancer patients quit smoking. The investigators are interested in what participants like and do not like about the game.

TERMINATED
Effects of ABT-089 on Smoking Abstinence Symptoms and Reward
Description

This Phase IIa within-subject, cross-over pilot study will evaluate the effects of ABT-089 (an experimental medication not approved by the FDA) when administered as 40mg oral once daily dose for 10 days, compared to placebo, on the following: abstinence-induced cognitive deficits, smoking withdrawal, smoking urges, smoking reward, and a brief, monitored quit attempt (\~4 days). The key cognitive domains include: working memory, sustained attention, and response inhibition.

COMPLETED
Effect of Galantamine on Smoking Abstinence
Description

This is a preliminary open-label study to determine whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt.

UNKNOWN
Preventing Relapse Following Involuntary Smoking Abstinence
Description

The prevalence of tobacco use in the military is too high. This study is designed to take advantage of the 8.5 weeks of forced tobacco cessation during Basic Military Training and develop effective interventions to prevent tobacco relapse. Hypotheses or Research Questions: * Are there differences in the rate of relapse between three groups participating in a tobacco abstinence maintenance intervention? * Do the tobacco abstinence maintenance interventions delay relapse?

COMPLETED
Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
Description

This project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. The second hypothesis is that smokers with schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more rewarding effects of smoking after a period of abstinence) than control smokers without psychiatric illness.

COMPLETED
Internet-based Group Contingency Management to Promote Smoking Abstinence
Description

The purpose of the study is to develop and test an Internet-based group contingency management program designed to promote smoking cessation.

COMPLETED
Contingency Management for Smoking Abstinence With Adolescent Smokers
Description

The primary objective of this research is to evaluate the effectiveness of this type of smoking cessation program by comparing a treatment group with a control group. A secondary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens participating in a quit-smoking program. Hypothesis 1. A greater proportion of the participants in the treatment condition will be verified as abstinent from smoking during the course of treatment than participants of the control condition. Hypothesis 2. It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.

UNKNOWN
Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence
Description

The purpose of this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt.

COMPLETED
Study of Smoking Abstinence
Description

Background: - Relapse following cigarette abstinence remains a common problem for smokers who are attempting to quit. Most research has focused on the acute withdrawal phase that occurs within the first 48 hours to 1 week after quitting; however, more information is needed on the experiences of smokers in longer durations of abstinence. Objectives: * To study the effects of long-term smoking abstinence. * To study the effects of cigarette-related cues on craving in longer periods of smoking abstinence. Eligibility: - Individuals at least 18 years of age who are current smokers (at least 10 cigarettes per day) and who want to quit but are not currently attempting to quit. Design: * Participants will be randomly assigned to abstain from all nicotine use for 7, 14, or 35 days. A fourth group of participants will also abstain for 35 days, but will undergo more testing sessions than the other groups. * All participants will have an initial orientation session in which they will complete questionnaires about their smoking habits and will respond to smoking-related cues to provide information about their cravings. * Participants will visit the clinic daily during their abstinence period, and provide urine and breath samples to test for tobacco use. Participants will receive compensation for every day that they do not use tobacco. * On the end day of the abstinence period, participants will return to the clinic, provide urine and breath samples, and undergo testing of their responses to smoking-related cues. Participants in the fourth group will have these tests on Days 7, 14, and 35 of abstinence; other participants will have the tests only once, at the end of their abstinence period. * After the required abstinence period, participants will enter a 5-day step-down period. They will continue to report to the clinic for breath and urine testing, and they will receive payments for abstinence that decrease in value across days. * After the step-down period, for the final 12 days of the study, participants will report to the clinic every 3 days to give urine and breath samples and to report the number of cigarettes smoked.

COMPLETED
S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence
Description

Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%. Currently available treatments among adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be continually developed and tested. The release of dopamine in the nucleus accumbens is one of the key components of the pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter availability (particularly dopamine and norepinephrine) are likely to increase the reward function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop smoking. SAMe is well tolerated and is available over-the-counter. To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial. Participants (N=120) will be randomly assigned to one of the three groups, and will receive an 8-week course of SAMe 800-mg per day, 1600-mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism, if the results appear promising.

COMPLETED
Neuroimaging Decision Making and Response Inhibition During Smoking Abstinence
Description

The broad objective of this proposal is to identify functional neuroanatomical correlates of impairments in response inhibition during smoking abstinence. We will measure changes in performance and regional blood oxygenation levels using functional magnetic resonance imaging (fMRI)while smokers complete tasks designed to assess decision making and response inhibition. Our primary hypothesis is that smoking abstinence will result in impaired response inhibition accompanied by decreases in blood-oxygenation-level-dependent (BOLD) fMRI signal in brain regions associated with these cognitive processes including frontal cortex and the ventral striatum. Abstinence may also result in performance-related increases in activation in brain regions associated with effortful processing including the anterior cingulate cortex in effort to compensate for deficits in other regions.

Conditions
COMPLETED
Testing Methylphenidate for Smoking Abstinence
Description

Cigarette smoking continues to be a major public health problem. Tobacco dependence interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for all smokers. A need exists for new medications to treat various aspects of tobacco dependence, such as the reinforcing effects of nicotine, relief of nicotine withdrawal symptoms and prevention of early relapse. The neurobiology of the effect of methylphenidate is similar to that of the reinforcing effects of nicotine. In a small previous study, methylphenidate was reported to improve nicotine withdrawal symptoms and short term quit rates. Methylphenidate is well tolerated, has low abuse potential, and is less expensive compared to other tobacco dependence interventions. ConcertaTM, a long acting preparation of methylphenidate, is administered once a day, has similar bioavailability as the generic drug administered 3 times a day and has an overall similar or improved efficacy compared to generic methylphenidate. We plan to obtain preliminary efficacy data in a randomized, placebo-controlled phase II study assessing the effect of methylphenidate in cigarette smokers for increasing 7-day point prevalence smoking abstinence at end of treatment and 7-day point prevalence and prolonged smoking abstinence at 6-months. Critical and systematic evaluations of newer, innovative, and well-tolerated treatments to help treat tobacco use and dependence will provide a wider choice of therapeutic agents to smokers wishing to become abstinent from tobacco use.

Conditions
ACTIVE_NOT_RECRUITING
Breathe 2 Project 3: Comprehensive Chronic Care
Description

This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. This research will compare CCC with Standard of Care (SC) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. Participation in the study will last 18 months.

NOT_YET_RECRUITING
Varenicline for Smoking Reduction in Veterans Not Ready To Quit
Description

In order to reduce the prevalence of cigarette smoking among Veterans, it is vital that the investigators offer effective tobacco treatment to all Veterans who smoke, including those not ready to make a quit attempt. Smoking treatments currently available to Veterans who are not ready to quit are only weakly effective. This project will generate new knowledge about the effectiveness of a promising varenicline-based intervention designed to increase quit attempts and long-term abstinence in Veterans who are initially not ready to quit. This project has great potential to engage Veterans not ready to quit smoking in treatment that increases quit attempts and quitting success, thereby reducing morbidity and mortality caused by smoking in Veterans.

COMPLETED
Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding
Description

This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.

COMPLETED
A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation
Description

The purpose of this study was to understand the biological and functional changes after one year of smoking cessation and to collect data on a broad range of biomarkers of exposure (BoExp) and biomarkers of effect (BoE).

TERMINATED
Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study
Description

The goal of this research study is to learn about 2 different interactive methods that are designed to help people with HIV/AIDS stop smoking.

COMPLETED
Smoking, Stress & Allopregnanolone Response
Description

This study aims to characterize the effect of smoking on stress-induced allopregnanolone (ALLO) response in women by menstrual phase. The investigators hypothesize that women who smoke will have a blunted ALLO response to stress.

COMPLETED
Smokers' Response to Nicotine Dependence Genotyping
Description

Innovative strategies to reduce adult smoking prevalence include using genetic information to motivate cessation and, ultimately, to tailor cessation pharmacotherapy. Success of these interventions depends, in part, on smokers' interest and participation in genetic testing related to cessation and their understanding and use of the results (i.e., their genetic literacy). The recent availability of genetic risk testing for a nicotinic acetylcholine receptor gene (CHRNA3) variant (rs105173) associated with nicotine dependence makes it highly feasible to investigate smokers' interest in and use of genetic information about nicotine dependence. Therefore, the primary purpose of this study is to determine the impact of an intervention that provides smokers with an educational session about genetic contributions to smoking and nicotine dependence plus their genotype results for rs1051730 on smoking cessation outcomes compared to those who receive only the educational session. Secondary purposes are to determine: (a) the impact of genetic education and knowing personal genotype results on genetic literacy outcomes and (b) the feasibility of recruitment and retention methods in a study addressing genotyping for nicotine dependence. Primary outcomes are cessation-related behaviors and cognitions indicating abstinence. Secondary outcomes are cognitions and emotions indicating genetic literacy. Knowledge gained from this study has the potential for clinical translation so that as genotyping becomes part of smoking cessation, health-care providers can understand and address factors influencing smokers' adaptation to genetically-informed cessation treatment. The study will use a longitudinal, repeated measures design (experimental, control; N=90; 45/group). All participants will receive a 90-minute educational session about genetic contributions for smoking and nicotine dependence and will donate a buccal swab sample for genotyping. The investigators will then randomize participants to two groups: those who receive genotyping results in a genetic counseling session (experimental) and those who do not (control). Follow-up data will be collected from both groups at baseline and weeks 2, 6, 10 after the experimental group receives genotyping results, with a brief follow-up and study termination occurring at week 12. Control group participants will be offered their genotyping results at the end of the study.

COMPLETED
Providing Free Nicotine Patches to Quitline Smokers
Description

The California Smokers' Helpline will conduct a 3 X 2 (nicotine patch by counseling condition) randomized trial to test the provision of nicotine patches to help smokers calling a telephone quitline. The study assesses one factor related to nicotine patches with 3 levels: sending patches directly from the Helpline, providing vouchers that can be redeemed for patches, and usual care. A second factor is counseling plus materials versus materials only. This proposed study has the following specific aims: 1. To demonstrate that a voucher for free nicotine patches will increase the quit rate for smokers who do not have access to free nicotine replacement therapy (NRT) 2. To demonstrate that sending patches directly from a quitline would outperform sending vouchers for free NRT, since the vouchers impose an additional barrier to those who want to quit 3. To determine the effect of telephone counseling in the context of nicotine patch distribution and if any interaction effects exist between counseling and patch conditions

COMPLETED
A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline
Description

California Smokers' Helpline will conduct a randomized trial to evaluate 3 strategies of services and/or incentives on smoking cessation rates. This project has the following specific aims: 1. To increase tobacco cessation among Medi-Cal beneficiaries who currently smoke, and to improve the management of diabetes and other chronic disease by means of tobacco cessation. 2. Demonstrate that tobacco cessation benefits that are well promoted and barrier free and include modest incentives, are effective in reducing smoking prevalence, lowering Medi-Cal health care costs, and improving health outcomes for diabetes management in particular.

COMPLETED
Smoking Cessation in Hospitalized Smokers
Description

When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients. The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.