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Pilot Study of Repetitive Transcranial Magnetic Stimulation in Cocaine Craving

NCT01222806 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-07-05

No results posted yet for this study

Summary

Background:

\- Cocaine addiction is often difficult to treat, particularly because exposure to others using cocaine or to pictures of cocaine may evoke cocaine craving and lead a person to resume cocaine use after having quit. Breaking this link with cocaine craving might improve treatment for cocaine addiction. Research suggests that repetitive pulses of transcranial magnetic stimulation (rTMS) applied to the skull can change nerve cell firing in the brain. rTMS was recently approved as a treatment for depression, and is being studied as a way to reduce drug craving. However, because only a few small studies have looked at the effects of rTMS on cocaine craving, more research is needed on whether it is effective in reducing cocaine craving and use in individuals who currently use cocaine on a regular basis.

Objectives:

\- To determine whether transcranial magnetic stimulation can lower craving for cocaine when given in connection with cocaine-related images.

Eligibility:

\- Individuals at least 18 years of age who have used cocaine for at least 2 years and currently using at least 3 times per week.

Design:

* This study involves an initial screening visit, two brain imaging sessions, five rTMS sessions, and two follow-up visits.
* Participants will be screened with a medical history, physical examination, urine samples, questions about drug use history and previous efforts to quit, and tests for breath alcohol and nicotine levels.
* Participants will have two magnetic resonance imaging (MRI) scan sessions: one baseline scanning session before starting their rTMS sessions and a second scanning session after their last rTMS session . Part of each scanning session involves functional MRI (fMRI) scans. During the fMRI scans, participants will look at pictures related to cocaine use and pictures that are not related to cocaine use. Participants will also perform a simple decision task during the scans.
* Participants will have five rTMS sessions, one per day for 5 days in a row. Each session will last 1 to 2 hours. Participants will have either real or sham (simulated) rTMS while looking at pictures that may or may not be related to cocaine use, and will also perform a simple decision task that is the same as the one given during the MRI scans. The decision as to whether participants get real or sham rTMS will be made by chance. Neither the participants nor the investigators will know which type the participants are getting. - Participants will have two follow-up visits one and two weeks after their last rTMS session. At each visit they will be checked for cocaine and other substance use and for possible side-effects from rTMS.

Conditions

  • Cocaine Use

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulation

Sponsors & Collaborators

  • 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
No

Timeline & Regulatory

Start
2010-10-11
Completion
2013-05-02

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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 NCT01222806 on ClinicalTrials.gov