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Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction

NCT01031693 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-04-05

No results posted yet for this study

Summary

Background:

* Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings.
* Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether TMS delivered in single pulses can decrease activity in the parts of the brain that respond to nicotine craving.

Objectives:

\- To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in cigarette smokers.

Eligibility:

* Individuals 18 years of age and older who are physically healthy and have smoked 10 or more cigarettes per day for at least 1 year.
* A small group of healthy nonsmoking control subjects 18 years of age and older will also participate in the study.

Design:

* The study will involve seven study visits and two follow-up visits. The control participants will have only two visits: one with a magnetic resonance imaging (MRI) scan and one with TMS to evaluate brain function and response.
* Participants will have an initial assessment about tobacco use habits and craving patterns, and will provide blood and urine samples before beginning the study.
* Participants will have two initial MRI brain scans. The first scan will look at the structure of the brain at rest. During the other scan, participants will look at images related to and not related to cigarette smoking.
* The single pulse TMS sessions (with either actual TMS or inactive \[sham\] TMS) will be held daily for 5 consecutive days. Magnetic pulses will be triggered by cigarette-related picture cues and delivered at varying intervals before the participant sees a cigarette-related picture. During these testing visits, researchers will ask questions related to tobacco use and craving, and collect urine and breath samples for further study.
* Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions, to evaluate memory and mood, and will have one final MRI brain scan at the end of the study.

Conditions

  • Nicotine Dependence

Interventions

DEVICE

Transcranial Magnetic Stimulation

daily sessions for 5 days

Sponsors & Collaborators

  • University of Maryland

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • David A Gorelick, M.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-13
Primary Completion
2013-08-28
Completion
2013-08-28

Countries

  • United States

Study Locations

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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 NCT01031693 on ClinicalTrials.gov