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Nicotine Dependence clinical trials

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NCT ID: NCT02590393 Completed - Nicotine Dependence Clinical Trials

The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence

Ecig1
Start date: May 21, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have been raised regarding the possibility that e-cigarettes will sustain a dependency on nicotine and that they may lead to continued use of conventional cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a dependence on nicotine, but it is likely that other tobacco constituents contribute to dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in animal models and to affect cravings in human smokers. E-cigarettes contain variable quantities of nicotine and NNTAs, but there is virtually no information available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these products. The proposed project will assess the acceptability, extent of switching behavior, and degree of dependence maintained when smokers are provided with e-cigarettes containing nicotine and NNTAs.

NCT ID: NCT02587312 Completed - Nicotine Dependence Clinical Trials

Evaluation of Very Low Nicotine Content Cigarettes in Adolescent Smokers

Start date: October 13, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine how reducing the level of nicotine in cigarettes may affect adolescent smoking behavior. In this study, the researchers will randomize adolescent (age 15-19) daily smokers to either receive VLNC cigarettes or normal-nicotine content (NNC) study cigarettes for three weeks following a one-week usual-brand baseline period. Participants will be instructed to smoke only those cigarettes. The researchers will conduct daily assessments of total cigarette use (both study cigarette and non-compliant use of usual brand cigarettes), craving, and withdrawal, weekly assessments of breath carbon monoxide (CO) levels, cigarette acceptability, risk perceptions of VLNC and NNC cigarettes and demand for usual-brand cigarettes, and pre- vs. post-use measures of nicotine and toxicant exposure. Overall, the project will help determine how VLNC cigarettes may affect real-world smoking behavior in adolescents, and illuminate the potential mechanisms through which these products may effect such changes. Such knowledge will contribute to the science base that may inform future policy decisions.

NCT ID: NCT02575183 Completed - Nicotine Dependence Clinical Trials

Varenicline (Chantix) Treatment for Waterpipe Smoking Cessation

Start date: August 31, 2016
Phase: Phase 4
Study type: Interventional

The lack of proven waterpipe smoking cessation interventions makes it important to explore interventions proven effective for cigarette smoking cessation. The investigators hypothesize that Varenicline (Chantix) administrated for 12 weeks is associated with higher sustained quit rate at 12 weeks compared to placebo. The investigators propose to conduct a randomized double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix), in two parallel groups each consisting of 76 habitual waterpipe smokers who are willing to quit. Potential participants will be approached in cafés, word-of-mouth and through media and will be invited to the American University of Beirut Medical Center to complete study procedures. Both study groups will receive the same behavioural intervention in combination with either Varenicline (Chantix), an FDA approved drug indicated for use as an aid to smoking cessation treatment, or placebo. Participants will complete study procedures in four visits. During visit-1 the informed consent process, baseline assessments and randomization will be completed and Varenicline (Chantix) or Placebo will be initiated together with the behavioural interventions. The behavioural intervention will be continued over the next 2 visits. An end of treatment visit 12 weeks after quit date will be dedicated to assessing sustained quit rate and other outcomes.

NCT ID: NCT02534454 Completed - Nicotine Dependence Clinical Trials

TDCS and Cognitive Retraining to Augment Pharmacotherapy for the Treatment of Nicotine Dependence

TDCSNIC
Start date: August 15, 2015
Phase: N/A
Study type: Interventional

The purpose of the phase 1 translational pilot study proposed here is to gather preliminary data investigating the efficacy of transcranial direct current stimulation (TDCS) and cognitive retraining to enhance nicotine replacement therapy for smoking cessation. The recent use of TDCS over task relevant regions to alter behavior holds incredible promise for use in cognitive retraining intervention protocols. Previous studies of cognitive retraining have focused on implicit training techniques. This proposed study will attempt to enhance these implicit training techniques through the use of TDCS during implicit retraining in order to increase learning of avoidance-related action tendencies towards tobacco. The objective of this pilot study is to establish the feasibility and obtain preliminary data on the effectiveness of using brain stimulation with cognitive retraining to reduce cigarette smoking in individuals with nicotine addiction.

NCT ID: NCT02527980 Completed - Smoking Clinical Trials

E-Cigarettes: Dynamic Patterns of Use and Health Effects

Start date: October 1, 2015
Phase:
Study type: Observational

The proposed research will provide in-depth, longitudinal data, based on real-time reports, which will address key priorities for the FDA including, increased understanding of the relations between electronic cigarette (e-cig) use and 1) nicotine dependence, 2) reductions in combustible cigarette (CC) use, 3) attempts to quit CC use and the success of those attempts, and 4) health-related outcomes such as biomarkers of exposure and carcinogenicity.

NCT ID: NCT02520349 Completed - Nicotine Dependence Clinical Trials

Lab to Real World Assessment of E-cigarette Abuse Liability and Appeal

Start date: May 2016
Phase:
Study type: Observational

The proposed research is a longitudinal human lab study to examine how measures of abuse liability and product appeal vary by e-cigarette device type, and how these lab assessments may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An additional aim is to evaluate e-cigarette safety and tolerability among smokers by device type.

NCT ID: NCT02514720 Completed - Nicotine Dependence Clinical Trials

Nicotine Metabolizers and [11C]-(+)-PHNO

MET
Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of nicotine metabolism on occupancy of [11C]-(+)-PHNO to DA 2/3 receptors in different brain areas during periods of abstinence and smoking during an abstinence. This will be a Positron Emission Tomography (PET) study and the radiotracer [11C]-(+)-PHNO (11C]-( + )-4-propyl- 3,4,4a,5,6,10b-hexahydro-2H-naphtho[1,2-b][1,4]oxazin-9-ol) will be used.

NCT ID: NCT02501265 Completed - Nicotine Dependence Clinical Trials

Adaptive Pharmacotherapy for Smoking Cessation

Start date: June 6, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess an "adaptive" approach to smoking cessation pharmacotherapy. The protocol is designed to compare adaptive vs. standard approaches to two common smoking cessation pharmacotherapies - Varenicline (commonly known as Chantix) and the Nicotine Patch. The investigators hypothesize that participants allocated to adaptive therapy will show significantly higher biochemically confirmed 30-day continuous abstinence at 12 weeks post-Target Quit Day (TQD).

NCT ID: NCT02500589 Completed - Nicotine Dependence Clinical Trials

Adjunctive Mood Management for Telephone-based Smoking Cessation

Start date: May 31, 2016
Phase: N/A
Study type: Interventional

Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that increase successful quit attempts among depressed smokers with chronic medical illnesses are particularly important for the VA healthcare system because rates of tobacco use, depression, and chronic medical illnesses are significantly higher among Veterans compared to the general population. Providing smoking cessation services augmented with mood management to Veterans via telephone may increase access to, and utilization of, evidence-based smoking cessation counseling and decrease rates of smoking-related complications for Veterans with chronic medical illnesses and depression. Yet, the reach of smoking cessation telephone counseling has been limited among populations with mental illness. The investigators intend to combine the potency of co-delivered mood management and reach of telephone-delivered interventions by testing the telephone delivery of behavioral mood-management for smoking cessation among smokers with depression and chronic medical illness.

NCT ID: NCT02498145 Completed - Smoking Clinical Trials

Short Term Effects of Electronic Cigarettes in Tobacco Dependent Adults

Start date: October 2014
Phase: N/A
Study type: Interventional

This is a pilot human experimental study to evaluate whether the use of an e-cigarette affects lung function, exhaled CO levels, and quantitative tobacco cigarette consumption in active tobacco smokers. Subjects recruited from the Winchester Chest Clinic (WCC), Adult Primary Care Clinic (PCC) and the Smilow Cancer Hospital Smoking Cessation Service will be randomized to 1 of 2 groups: (1) nicotine patch and intensive counseling (standard care) plus nicotine e-cigarette; (2) nicotine patch and intensive counseling plus non-nicotine e-cigarette.