N/A
Completed N=40
QuitFast: Evaluating Transcranial Magnetic Stimulation as a Tool to Reduce Smoking Directly Following a Quit Attempt
Source: ClinicalTrials.gov NCT04159571 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2024
Primary outcomePrimary: Questionnaire on Smoking Urges Administered Daily Pre TMS to Measure Craving — 16; 12 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Questionnaire on Smoking Urges Administered Daily Pre TMS to Measure Craving |
16; 12 | — |
| PRIMARY Self- Report Assessment of Cigarette Use Through Timeline Follow-Back (TLFB) Interview |
10; 12 | — |
| SECONDARY Biochemical Assessment of Tobacco Use Via Quantitative Urine Screens to Detect Cotinine Level |
1872; 1374 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-75 (to maximize participation, and minimize effects of cortical atrophy on neuroimaging data)
- Current cigarette smoker (at least 10 cigarettes per day).
- Able to read and understand questionnaires and informed consent.
- Has accommodations within 50 miles of the study site.
- Is not at elevated risk of seizure (i.e., does not have a history of seizures, is not currently prescribed medications known to lower seizure threshold)
- Does not have metal objects in the head/neck.
- Does not have a history of traumatic brain injury, including a head injury that resulted in hospitalization, loss of consciousness for more than 10 minutes, or having ever been informed that they have an epidural, subdural, or subarachnoid hemorrhage.
- Does not have a history of claustrophobia leading to significant clinical anxiety symptoms.
Exclusion Criteria
- Any psychoactive illicit substance use (except marijuana, alcohol, and nicotine) within the last 30 days by self-report and urine drug screen. For marijuana, no use within the last seven days by verbal report and negative (or decreasing) urine THC levels. Participation will be discontinued if participants use psychoactive illicit substances (except nicotine and alcohol) after study initiation.
- Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for current axis I disorders of major depression, panic disorder, obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, eating disorders, and any other psychotic disorder or organic mental disorder.
- Has current suicidal ideation or homicidal ideation.
- Has the need for acute treatment with any psychoactive medication including anti-seizure medications and medications for attention-deficit/ hyperactivity disorder.
- Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are not using a reliable form of birth control.
- Has current charges pending for a violent crime (not including DUI related offenses).
- Does not have a stable living situation.
- Suffers from chronic migraines.
- Does not have a stable phone number for contact through calling and/or texting.
- Does not have a stable means of using WebEx (e.g. personal computer, Internet) for interaction with study personnel during COVID-19.
Data sourced from ClinicalTrials.gov (NCT04159571). 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.