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N/A Completed N=119 Treatment

Neural Mechanisms Associated With Risk of Smoking Relapse

Source: ClinicalTrials.gov NCT02837510 ↗
Enrolled (actual)
119
Serious AEs
0.9%
Results posted
Mar 2025
Primary outcomePrimary: Days to Relapse — 3.95; 3.78 days

Summary

This study will examine how abstinence-induced brain changes contribute to smoking cessation outcomes in treatment-seeking smokers.

Outcome Measures

OutcomeResultp-value
PRIMARY
Days to Relapse
3.95; 3.78
SECONDARY
Brain Activation (BOLD Percent Signal Change)
0.23; 0.26; 0.22; 0.23; 0.21; 0.24

Eligibility Criteria

Inclusion Criteria

Eligible participants will be:

  • Treatment-seeking smokers between the ages of 18 and 65, reporting consumption of at least 5 cigarettes per day for at least the past 6 months;
  • Planning to live in the area for at least the next 3 months;
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
  • Able to communicate fluently in English (speaking, writing, and reading).

Exclusion Criteria

Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study:

Smoking Behavior:

  • Use of chewing tobacco or snuff or cigars;
  • Current enrollment or plans to enroll in another smoking cessation program or research study in the next 3 months;
  • Current or anticipated (within the next 3 months) use of smoking cessation medications or nicotine replacement therapy (NRT);
  • A baseline carbon monoxide (CO) reading less than or equal to 8ppm.

Alcohol/Drugs:

  • Diagnosis or treatment for alcohol or drug abuse in the past two years as reported during phone screen (e.g., alcohol, opioids, cocaine, or stimulants);
  • Current alcohol consumption that exceeds 25 standard drinks/week;
  • Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at intake;

a. Participants testing positive for breath alcohol with a reading equal to or greater than .08 (the legal driving limit) or who are visibly impaired will be instructed not to drive themselves home after the appointment. If a participant needs to use a phone to call for a safe ride home, an office telephone will be made available to the participant.

  • A positive urine drug screen for cocaine, opiates, PCP, benzodiazepines, methadone, MDMA, amphetamine, methamphetamine, tri-cyclic antidepressants and/or barbiturates at any session;

Medication:

Current use or recent discontinuation (within the past 30 days at the time of Intake) of:

  • Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix, NRT);
  • Anti-psychotic medications;
  • Anti-depressants (tricyclics, SSRI's, selective and nonselective MAOIs, Wellbutrin/Zyban);
  • Anti-anxiety agents;
  • Anti-panic agents;
  • Prescription (e.g., Provigil, Ritalin) or over-the-counter stimulants;
  • Prescription sleep aids (e.g., Ambien, Lunesta) if used more than 2x/week. If participants report use less than twice a week, they will just be asked to refrain from use during imaging portion of the study.
  • Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician;

Daily use of:

  • Opiate-containing medications for chronic pain.

Medical/Neuropsychiatric:

  • Women who are pregnant, planning a pregnancy, and/or breast feeding. All female subjects of childbearing potential will undergo a urine pregnancy test at Intake and both fMRI scan visits (3 urine pregnancy tests in total).
  • History of epilepsy or a seizure disorder;
  • History of stroke;
  • Self-reported brain or spinal tumor;
  • Self-reported history or current diagnosis of psychosis, bipolar disorder, schizophrenia, current major depression (subjects with a history of major depression but in remission for past 6 months are eligible), or any Axis 1 disorder.

fMRI-Related:

  • Self-reported history of head trauma;
  • Self-reported brain (or CNS) or spinal tumor;
  • Self-reported use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for fMRI;
  • Self-reported history of claustrophobia;
  • Being left-handed;
  • Color blindness;
  • Weight greater than 299lbs;
  • Self-reported history of gunshot wounds;
  • Any impairment preventing participants from using the response pad necessary for the cognitive testing;
  • Circumstances or conditions that may interfere with magnetic resonance imaging (MRI).

General Exclusion:

  • Any medic
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02837510). 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. Informational only — not medical advice.

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