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Deep rTMS and Varenicline for Smoking Cessation

NCT04083144 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-11-04

Study results available
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Summary

The purpose of this study is to investigate the effect of deep repetitive transcranial magnetic stimulation (rTMS) using the insula H-coil on smoking outcomes in smokers receiving varenicline. It is hypothesized that active deep rTMS will improve abstinence rates, attenuate craving and reduce cigarette consumption and dependence severity.

Conditions

  • Tobacco Use Disorder
  • Smoking Cessation

Interventions

DEVICE

Deep Repetitive Transcranial Magnetic Stimulation (Active)

Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula

DEVICE

Deep Repetitive Transcranial Magnetic Stimulation (Sham)

Sham deep rTMS using the H-coil. The sham coil is built into the same helmet as the active coil. It mimics the active coil with regards to acoustics and scalp sensations.

DRUG

Varenicline

12 week course treatment of varenicline (0.5 mg/1 mg) using the standard dosage schedule for smoking cessation (Day 1-3: 0.5 mg daily; day 4-7: 0.5 mg twice a day; day 8-end of treatment: 1 mg twice a day).

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Brainsway

    collaborator INDUSTRY

  • Centre for Addiction and Mental Health

    lead OTHER

Principal Investigators

  • Bernard Le Foll, MD,PhD,MCFP · Centre for Addiction and Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-22
Primary Completion
2022-09-13
Completion
2022-12-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04083144 on ClinicalTrials.gov