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N/A N=112 Randomized Double-blind Basic Science

Nicotine Withdrawal Symptoms and Smoking Relapse

Nicotine Dependence

Enrolled (actual)
112
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation — 1.051567464; 0.867749333; 0.8973946; 1.143702607 Percent BOLD change

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Transcranial Direct Current Stimulation (Device); sham (Device); Nicotine patch (Drug); Placebo patch (Drug); Varenicline Pill (Drug); Placebo pill (Drug); Motivational Interviewing (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Institute on Drug Abuse (NIDA)
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
BOLD Activation in Right ACC During Parametric Flanker Task tDCS Stimulation
1.051567464; 0.867749333; 0.8973946; 1.143702607; 1.1765768; 1.0322936
PRIMARY
dACC Glutamate
1.5; 1.54
PRIMARY
Behavioral Accuracy on N-Back Working Memory Task
91.43; 97.56; 94.67; 89.88; 93.33; 87.11
PRIMARY
Behavioral Reaction Speed on N-Back Working Memory Task
2.24; 2.36; 2.20; 2.13; 2.22; 2.05
PRIMARY
Behavioral Accuracy on the Parametric Flanker Task
98.87; 98.88; 98.83; 97.97; 98.50; 98.26
PRIMARY
Behavioral Reaction Speed on the Parametric Flanker Task
2.31; 2.37; 2.23; 2.17; 2.21; 2.08
PRIMARY
Behavioral Accuracy on the Matching Task
96.09; 98.33; 96.58; 98.28; 97.02; 96.08
PRIMARY
Behavioral Reaction Speed on the Matching Task
1.06; 1.18; 1.07; .90; 1.00; .89
PRIMARY
Nicotine Withdrawal From WSWS
43.5; 50.8
PRIMARY
Nicotine Craving From TCQ-SF
46.7; 51.9
PRIMARY
Affect From PANAS
34.8; 31.2; 11.7; 13.3

Summary

Background: - Smoking is thought to cause changes in the brain that lead to addiction and craving. Smokers who try to quit experience nicotine withdrawal symptoms that include irritability, anxiety, and difficulty concentrating. These symptoms make it difficult for people to stop smoking. Many people say that they continue smoking to help relieve these symptoms, often within the first week after trying to quit. Researchers want to study what is happening in the brain to cause these symptoms, which may help identify new ways to successfully quit smoking. Objectives: - To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for 36 hours. Eligibility: - Individuals between 18 and 65 years of age who smoke at least 10 cigarettes per day. Participants must be able to stop smoking for 36 hours on two occasions. Design: Phase 1 * This study will involve three visits to the National Institute on Drug Abuse. * NOT be able to smoke for 36 hours before the two imaging visits. * Wear a nicotine skin patch or a placebo (fake) patch during your 36 hour smoking abstinence period and study visits. * Have your blood drawn to test for levels of stress-related hormones. * Complete multiple MRI scanning sessions that last about 1.5 to 2 hours each. * Undergo EEG (brain waves) recording. * Answer questionnaires about how you think and feel. * Complete various tasks and procedures inside and outside of the MRI scanner. Phase 2 * This study will involve thirteen visits to the National Institute on Drug Abuse. * Set a quit date and develop a treatment plan with a study therapist. * Take Chantix (varenicline) every day for a period of 12 weeks. * Meet for weekly and biweekly counseling sessions with a therapist. * Answer questionnaires about how you think and feel. Phase 3 * This study will involve three visits to the National Institute on Drug Abuse. * Complete an MRI scanning session that will last about 20min each visit * Meet with a study staff member on each visit who will ask you questions about your smoking behavior and how you think and feel.

Eligibility Criteria

  • INCLUSION CRITERIA:

All Subjects must:

  • Be between the ages of 18-65.
  • Be right-handed. Assessment tool(s): Edinburgh Handedness Inventory.
  • Be in good health. Justification: Many illnesses may alter fMRI signals as well as cognitive processes and neural functioning. Assessment tool(s): Participants will provide a brief health history during phone screening, and undergo a medical history and physical examination with a qualified IRP clinician.
  • Be free of current moderate to severe DSM-V Substance Use Disorder on any drug, except nicotine in smokers. Those with past moderate to severe use disorder on substances may be included, provided they are in sustained remission (and not on maintenance therapy for opioid use disorder) and are not intoxicated on the day of the imaging session. Justification: Moderate to severe use disorder on other substances may result in unique CNS deficits that could confound results and introduce excessive variance, while mild substance use disorder and substance use disorder in remission are common in community samples of smokers. Assessment tool(s): Computerized SCID or comparable assessment and DSM-5 substance use disorder assessment.
  • Be able to abstain from alcohol and other recreational drugs for 24 hours before each imaging session, and able to moderate caffeine intake 12 hours before each imaging session. Justification: Recent substance use, including alcohol, and caffeine modulate neural functioning in a way that would complicate data interpretation. Assessment tool(s): Self-report, breathalyzer, and urine toxicology screen with follow up neuromotor assessment to ensure absence of acute impairment with positive urine test.
  • Smokers must meet the additional criteria:
  • Have a urine cotinine level corresponding to smoker status for the specific test being used, typically corresponding to a urine cotinine above about 200 ng/ml, and have been smoking for at least 1 year. Justification: The present protocol is interested in neurobiological mechanisms that underlie nicotine withdrawal, and is thus contingent on the presence of nicotine dependence. Assessment tool(s): Selfreport, commercial urine cotinine test corresponding to smoker status for the specific test being used, typically corresponding to a urine cotinine above about 200 ng/ml.
  • Be able to abstain from smoking for 12 hours prior to MRI-tDCS study sessions. Justification: The present protocol will investigate the effect of acute nicotine withdrawal on cognitive processes and response to tDCS. Assessment: Self-report and expired CO levels
  • In addition, non-smokers must meet:
  • Not have a history of daily cigarette smoking or have used any nicotine products continuously lasting more than a month, and no smoking or continuous use of any nicotine products within the past year. Assessment Tools: Self-report, urine cotinine test, and expired CO levels.

EXCLUSION CRITERIA

All participants will be excluded if they:

  • Are not suitable to undergo an fMRI experiment due to certain implanted devices (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts), body morphology, or claustrophobia. Justification: MR scanning is one of the primary measurement tools used in the protocol. Assessment tool(s): Prospective participants will fill out an MRI screening questionnaire and undergo an interview with an MR technologist. Questions concerning suitability for scanning will be referred to the MR Medical Safety Officer. Prospective participants will be questioned about symptoms of claustrophobia and placed in the mock scanner during their first visit to assess for possible difficulty tolerating the confinement of the scanner and for ability to fit into the scanner.
  • Have musculoskeletal abnormalities restricting an individual s ability to lie flat for extended periods of time. Justification: MR scanning sessions require participants to lie flat on their backs and remain perfec
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01511614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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