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Report for D014029: Tobacco Use Disorder NIH

(Synonyms: Tobacco Use Disorder)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)


Name (Synonyms) Correlation
drug2683 Web + text smoking cessation intervention Wiki 0.71
drug2252 Sham iTBS to the dlPFC Wiki 0.71
drug2033 Real cTBS to the vmPFC Wiki 0.71
drug2034 Real iTBS to the dlPFC Wiki 0.71
drug2251 Sham cTBS to the vmPFC Wiki 0.71
drug2457 Telemedicine Wiki 0.41
drug568 Chloroquine phosphate Wiki 0.41

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D016739 Behavior, Addictive NIH 0.35

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0030858 Addictive behavior HPO 0.35

There are 2 clinical trials

Clinical Trials


1 QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt

Cigarette smoking constitutes the greatest preventable cause of mortality and morbidity in the US. The most critical period for long term success of smoking cessation appears to be in the first 7 days after the quit date. A metaanalysis of 3 pharmacotherapy trials revealed that abstinence during the first 7 days was the strongest predictor of 6 month outcomes (n=1649; Odds ratio: 1.4, P <0.0001; Ashare et al. 2013). Prodigious relapse rates during this first week of smoking cessation are likely due to behavioral and neurobiological factors that contribute to high cue-associated craving and low executive control over smoking. The long term goal of the research is to develop evidence-based transcranial magnetic stimulation protocols to facilitate abstinence during this critical period.

NCT04159571 Smoking Smoking Cessation Craving Addiction Addiction Nicotine Nicotine Dependence Cigarette Smoking Device: Real cTBS to the vmPFC Device: Sham cTBS to the vmPFC Device: Real iTBS to the dlPFC Device: Sham iTBS to the dlPFC
MeSH:Tobacco Use Disorder Behavior, Addictive
HPO:Addictive behavior

Primary Outcomes

Description: The effect of real vs. sham iTBS to the left DLPFC vs. real vs. sham cTBS to the left MPFC as a tool to modulate the brain response to cigarette cravings will be assessed by comparing the brain activity in the executive circuit and limbic circuit before and after TMS. Participants will receive an MRI brain scan before their first TMS treatment, and at the end of their 10th days of TMS. At each MRI scan, participants will be subjected to a cigarette craving "cue" task within the scanner where elevated brain activity (BOLD signal) will be measured using an fMRI sequence. During each scan, they will see pictures of cigarette cues, neutral cues, and blurred images. The task is meant to induce craving and see how the brain responds to these craving cues.

Measure: Neuroimaging outcomes: changes in drug cue reactivity as specified by changes in BOLD signal

Time: Through study completion, an average of 8 weeks

Description: Participants will be asked to choose between two conditions in which varying amounts and delays to behavioral outcomes (e.g., $50 now or $100 later) are presented. We will use magnitudes of $100 and $1000 which are the most thoroughly documented among the literature. Across consecutive choices, the delay to the larger outcome will be titrated until reaching the participant's indifference delay (i.e., the delay at which s/he equally values both options). This indifference delay indexes individual participants' rates of delay discounting. Monetary delay discounting has been documented to be predictive to treatment success for smokers.

Measure: Changes in Delayed Discounting Cognitive Behavioral Task

Time: Through study completion, an average of 8 weeks

Description: This 10-item questionnaire assesses cigarette craving. Participants will be asked to rate from 1 (strongly disagree) to 100 (strongly agree) their agreement with several statements (e.g., "I have a desire for a cigarette right now," and "Nothing would be better than smoking a cigarette right now."). Factor analyses support two factors: one that reflects a strong desire and intention to smoke and one that reflects relief from negative affect associated with an urgent desire to smoke.

Measure: Questionnaire on Smoking Urges administered daily both pre/post TMS to measure craving

Time: Through study completion, an average of 8 weeks

Description: The hypothetical purchase task (HPT), a validated measure for cigarette demand, will assess cigarette purchases at various price conditions. Participants will hypothetically purchase quantities of cigarettes to use over a 24-hour period across ascending prices (e.g., $0, 0.12, $0.25, $0.50, $1.00, and $2.00 per cigarette). The HPT has been shown to be predictive of treatment outcomes. It will measure how participants value cigarettes throughout the course of the study visits.

Measure: Hypothetical Purchase Task to measure tobacco product value and sensitivity

Time: Through study completion, an average of 8 weeks

Secondary Outcomes

Description: Changes in cigarette use as detected by quantitative cotinine urine screens collected at visits 1, 6, 10, and all follow-ups

Measure: Biochemical assessment of tobacco use via quantitative urine screens to detect cotenine level

Time: Through study completion, an average of 8 weeks

Description: This self-reported tobacco product use interview asks participants to retrospectively estimate the number of tobacco products they've used each day for the past 30 days or since the previous assessment, whichever is fewer.

Measure: Self- report assessment of tobacco use through Timeline Follow-Back (TLFB) Interview

Time: Through study completion, an average of 8 weeks

Description: Breath CO provides an accurate measure of recent exposure to CO, including from smoking combustible tobacco products (95). The CO measurement will be used to determine recency of smoking.

Measure: Biochemical assessment of recent tobacco use via breath Carbon Monoxide (CO) sample

Time: Through study completion, an average of 8 weeks

2 Improving Smoking Cessation in Socioeconomically-Disadvantaged Young Adults

The purpose of this study is to understand how to develop and deliver a better smoking cessation program for lower-income young adult smokers.

NCT04379388 Nicotine Dependence, Cigarettes Behavioral: Web + text smoking cessation intervention
MeSH:Tobacco Use Disorder

Primary Outcomes

Description: Self-reported smoking abstinence and biochemical validation (saliva cotinine)

Measure: 30-day point prevalence smoking abstinence

Time: Assessed at 3-month follow-up

Description: Confidence to quit within the next month (7days) on 0-10 scale

Measure: Self-efficacy to quit smoking

Time: Assessed at 3-month follow-up

Description: Completing 75% or more of 12 weekly check-ins

Measure: Intervention engagement

Time: 12 weeks

Secondary Outcomes

Description: Self-reported smoking abstinence

Measure: 7-day point prevalence smoking abstinence

Time: Assessed at 3-month follow-up

Description: Number of times intentionally stopped smoking cigarettes for 24 hours or longer because trying to quit

Measure: Number of 24-hour quit attempts

Time: Assessed at 3-month follow-up

Description: 4 items pertaining to quit support from the text messages

Measure: Perceived support to quit smoking

Time: Assessed 3-month follow-up

Description: Past 30 (90 day) use of tobacco or nicotine products such as cigars, e-cigarettes, chewing tobacco, and nicotine replacement products

Measure: Pattern and rate of tobacco/e-cigarette use

Time: Assessed at 3-month follow-up


HPO Nodes