Neural Mechanisms Associated With Risk of Smoking Relapse
Source: ClinicalTrials.gov NCT02837510 ↗Summary
Outcome Measures
| Outcome | Result | p-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
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.