Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Nicotine Withdrawal Symptoms and Smoking Relapse
NCT01511614 · View on ClinicalTrials.gov ↗
Study 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 staf
Conditions Studied
Interventions
- DEVICE Transcranial Direct Current Stimulation
- DRUG Varenicline Pill
- DRUG Nicotine patch
- DEVICE sham
- DRUG Placebo patch
Study Locations (1)
Maryland
- National Institute on Drug Abuse — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2013-05-20 |
| Est. Completion | 2020-03-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01511614
The ClinicalTrials.gov registry entry for NCT01511614 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 108 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 5 interventions — of which Transcranial Direct Current Stimulation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01511614 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01511614 about?
NCT01511614 is a clinical study titled "Nicotine Withdrawal Symptoms and Smoking Relapse". 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 peo...
What is the current status of trial NCT01511614?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2013-05-20. Estimated completion is 2020-03-30.
What conditions does trial NCT01511614 study?
This clinical trial studies the following conditions: Nicotine Dependence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01511614?
The interventions under investigation include: Transcranial Direct Current Stimulation (DEVICE), Varenicline Pill (DRUG), Nicotine patch (DRUG), sham (DEVICE), Placebo patch (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01511614?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 108 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01511614 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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