Effect of a Non-Invasive Brain Stimulation Technique on Smoking Cessation Behaviors

NCT03386253 | Completed Results FDA Device

• 1 other identifier: STUDY00000789
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

In this pilot study, the feasibility of using tDCS (a non-invasive brain stimulation technique) while performing a task requiring cognitive flexibility will be examined in smokers and initial data will be collected regarding the effect of tDCS on smoking cessation behaviors. Smokers will be randomized to receive either active or sham tDCS daily for 5 days after which they will attempt to quit smoking. Smoking behavior after the attempted quit date will be assessed at four weekly visits.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants Willing to Complete 5 Days of tDCS or Sham

  As a feasibility study, the primary endpoint will be to determine if smokers are willing to enroll into and complete a study evaluating tDCS. Number of smokers enrolled and number who complete the 5 day tDCS procedures will be assessed.

  5 days

Secondary Outcomes (1)

• Change in Number of Cigarettes Smoked Per Day

  4 weeks

Study Arms (2)

active tDCS

EXPERIMENTAL

Participants receive active tDCS for five consecutive days before attempting to quit smoking

Device: active tDCS

sham tDCS

SHAM COMPARATOR

Participants receive sham tDCS for five consecutive days before attempting to quit smoking

Device: sham tDCS

Interventions

active tDCS DEVICE

two 13 minute tDCS sessions separated by 20 minutes in between

active tDCS

sham tDCS DEVICE

sham tDCS session given for same length of time as active

sham tDCS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 18 and 64
• Smoked (on average) at least 5 cigarettes per day
• Be motivated to quit smoking

You may not qualify if:

• Unstable medical or psychiatric conditions
• Any medical conditions with neurological sequelae
• History of loss of consciousness of greater than 30 minutes duration or loss of consciousness with neurological sequelae
• Have any medical condition or use any medication that would either increase risk of subjects participating in this study (e.g., medications that lower the seizure threshold) or that would impact measures of interest (e.g. smoking cessation medications).
• Are pregnant or planning to become pregnant during the study
• Current use of pacemaker, intracranial electrodes or implanted defibrillator

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Clinical and Translational Sciences Institute

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Michael Kotlyar
• Organization: University of Minnesota

kotly001@umn.edu

612-625-1160

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 29, 2017
• Study Start: January 1, 2018
• Primary Completion: November 21, 2018
• Study Completion: November 21, 2018
• Last Updated: March 6, 2023
• Results First Posted: March 6, 2023

Record last verified: 2022-05

Locations

US (1)