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Nicotine Dependence clinical trials

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NCT ID: NCT03272685 Completed - Nicotine Dependence Clinical Trials

Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace

Start date: June 1, 2018
Phase: Phase 3
Study type: Interventional

This project will examine the impact of very low nicotine content (VLNC) cigarettes in a complex tobacco and nicotine product marketplace. We will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains VLNC cigarettes versus normal nicotine content (NNC) cigarettes.

NCT ID: NCT03262233 Completed - Nicotine Dependence Clinical Trials

Stress Neuroadaptation in Tobacco Dependence

Start date: April 1, 2015
Phase: Phase 4
Study type: Interventional

The objective of the current study is to evaluate the validity of the No Shock, Predictable Shock, Unpredictable Shock (NPU) stressor task for use as a surrogate endpoint to predict short-term clinical outcomes among smokers during a smoking cessation attempt.

NCT ID: NCT03248713 Terminated - Nicotine Dependence Clinical Trials

Glucocorticoid Antagonist Treatment for Tobacco Use Disorder

Start date: November 29, 2017
Phase: Early Phase 1
Study type: Interventional

The purpose of this protocol is to examine whether mifepristone, a medication with glucocorticoid receptor antagonist activity, may be a potential treatment for Tobacco Use Disorder (TUD). Mifepristone has already shown promise as a potential treatment for PTSD (1) and alcohol use disorder (AUD) (2), but no previous studies have examined the therapeutic potential of mifepristone for TUD. This will be a double-blind, placebo-controlled study on the effects of a 7-day treatment with 600 mg mifepristone, or placebo, on cognitive function, tobacco withdrawal severity, and smoking behavior.

NCT ID: NCT03243630 Completed - Nicotine Dependence Clinical Trials

Effects of Flavors on Nicotine Reinforcement in Smokers

Start date: April 23, 2018
Phase: Early Phase 1
Study type: Interventional

To examine the acute reinforcing effects of menthol, a fruit flavor (green apple) or a fruit flavor plus menthol, alone or in combination with nicotine in smokers. Flavors will be administered by inhalation via electronic cigarettes (e-cigarettes) and nicotine will be administered intravenously. The reinforcing drug effects will be measured with the drug effects questionnaire (DEQ).

NCT ID: NCT03213418 Terminated - Smoking Cessation Clinical Trials

Electroretinogram: a New Human Biomarker for Smoking Cessation Treatment

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

This project aims to develop electroretinogram as a new putative marker for dopamine release, and as a predictor of treatment response among patients seeking treatment for smoking cessation. Tobacco smoking continues to be a major public health challenge. Dopamine is a neurotransmitter released in the brain. Several lines of evidence suggest that dopamine release deficit in the brain is involved in the development and maintenance of nicotine dependence. The investigators hypothesize that smokers who do not have a deficit in dopamine release will more readily respond to behavioral treatment for smoking cessation, and in particular, financial incentives contingent on abstinence (Contingency Management). Previous pilot data suggest electroretinogram (ERG), which records electrical signals from the retina in response to light, is a clinically accessible correlate to dopamine release in the brain. The project proposes an ERG-based biomarker, and a pilot clinical trial to apply this biomarker to personalize smoking cessation treatment. This clinically tractable biomarker of central dopamine release may have a large number of future applications in the diagnosis and treatment of other mental illnesses and substance use disorders. The study will recruit normal controls and smokers, measure ERG before and after a standard dose of oral immediate release methylphenidate. Smokers will undergo a 12-week standardized treatment course of CM. The investigators will test whether smoking status and the response to CM are correlated to changes in ERG in response to methylphenidate challenge.

NCT ID: NCT03196102 Completed - Nicotine Dependence Clinical Trials

Evaluation of a Brief Tobacco Intervention in the US Military

Start date: April 5, 2017
Phase: N/A
Study type: Interventional

While the military has taken steps to reduce tobacco use over the past two decades, over a quarter of new military recruits report regular tobacco use prior to enlistment. This rate is higher than the national prevalence of 21.3% of US adults. Brief health prevention programs may be particularly effective for Airmen in Technical Training, given that all Airmen have been tobacco free for 11 ½ weeks and nearly 2/3rds are confident that they won't return to tobacco. We have developed and validated a Brief Tobacco Intervention (BTI) that is currently being implemented as part of Technical Training. We found that a motivational interviewing based, 40 minute BTI was efficacious in increasing perceived harm and decreasing intentions to use tobacco in a sample of 1055 Air Force trainees. Although we obtained significant positive changes in latent cognitive constructs for tobacco behavior that are highly predictive of future tobacco use in youth and young adults, the Little et al study did not obtain measures of actual tobacco resumption following the ban on tobacco in Air Force training. Given that 69.8% of all tobacco resumption/initiation occurs in Technical Training, a study that evaluates the short-term impact of our BTI on actual tobacco use is necessary prior to conducting the full scale R01 that would evaluate the long term efficacy of the BTI intervention. Thus, we propose the following Specific Aims: (1) To recruit approximately 2,000 Air Force trainees at the beginning of Technical Training at Joint Base San Antonio-Lackland Air Force in San Antonio, Texas during the 11 ½ week involuntary cessation ban; (2) To randomize participants to either (a) receive our cigarette smoking military tailored pamphlet (HL095758), The Airmen's Guide to Remaining Tobacco Free (Airmen's Guide; which has been disseminated and is now the standard of care in the Air Force) or (b) the Airmen's Guide + Brief Tobacco Intervention (BTI); (3) To determine the short-term (3 month, end of Technical Training) efficacy of the intervention on tobacco abstinence. Our primary outcome is tobacco abstinence at the end of Technical Training to determine an estimated effect size as well as establish the requisite preliminary work for a subsequent R01. Given that over 220,000 new recruits enter the military annually in one of the service branches, the public health implications of an effective brief tobacco intervention targeting the most commonly used tobacco for military personnel in Technical Training is considerable. If the BTI is proven efficacious it can be easily disseminated to other service branches that have similar tobacco bans during Technical Training.

NCT ID: NCT03194958 Completed - Smoking Cessation Clinical Trials

Helping Poor Smokers Quit

Start date: June 5, 2017
Phase: N/A
Study type: Interventional

Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

NCT ID: NCT03190161 Completed - Schizophrenia Clinical Trials

Music to Reduce Use of Smoking in Patients With Schizophrenia

Start date: March 9, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the impact of self-selected music listening which targets disrupting the reward process maintaining smoking and additionally attenuating the reward processing deficits associated with schizophrenia. Five participants with schizophrenia/schizoaffective disorder who smoke/nicotine will participate in an individual session of self-selected music listening for a half an hour.

NCT ID: NCT03177265 Completed - Nicotine Dependence Clinical Trials

Text Messaging to Engage and Retain Veterans in Smoking Cessation Counseling

TiMES
Start date: November 8, 2018
Phase: N/A
Study type: Interventional

Tobacco-related diseases account for a significant portion of all VA healthcare costs and are a detriment to the health and quality of life of our Veterans. Despite progress in instituting tobacco screenings and treatment referral, most Veterans still do not receive the most effective strategy to help them quit smoking - pharmacotherapy combined with behavioral coaching. This study builds on findings from population health and mobile interventions to help more Veterans receive evidence-based tobacco treatment. The investigators propose to test the effect of two types of text messaging in combination with telephone cessation counseling: 1) pre-counseling text messages to increase enrollment in counseling, and 2) ongoing texts for those who start counseling that provide appointment reminders and support between sessions to increase adherence to counseling. This study supports multiple goals of the VA's Blueprint for Excellence. Results will directly inform decision-making and population-based care models for tobacco treatment.

NCT ID: NCT03173274 Terminated - Nicotine Dependence Clinical Trials

Incentives to Promote Smoking Cessation in Low SES Women

ProjectMIST
Start date: February 8, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the feasibility of a mobile-phone based contingency management (CM) intervention for smoking in low-SES women. The CM intervention will be combined with a Brief Motivational Interviewing (BMI) counseling component. This study will examine the following research aims: Primary Aim: To compare the effects of a Brief Motivational Intervention (BMI) + mobile phone-based CM on tobacco use when compared to BMI with a non-contingent control condition in a small feasibility trial. Hypothesis: The investigators expect women in the BMI + CM condition to have more smoke free days than women in the BMI + NC condition. Secondary Aim: To examine alcohol use as a moderator of cessation outcomes.