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AlcoholismEarly Phase 1addictionTBSNCT02939352

The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues

A Early Phase 1 study testing Real continuous Theta Burst Stimulation in people with Alcoholism and Cocaine Addiction, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

High relapse rates among substance dependent individuals are likely due to a combination of factors that involve limbic circuits in the brain involved in craving, including vulnerability to salient cues. Read more about this study

Who is it for?
Ages 25 to 55 years
Conditions the study is for
Alcoholism, Cocaine Addiction, Drug Addiction
What is being tested?
Real continuous Theta Burst Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
1 siteUnited States
Study dates
Sep 2014to Dec 2015
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 25-55
  • Non-treatment seeking cocaine users (with or without comorbid alcohol use disorder)
  • Current alcohol use greater than 20 standard drinks per week
  • Current DSM-V Alcohol Use Disorder diagnosis, including the loss of control item
  • Currently not engaged in, and do not want treatment for, alcohol related problems
  • Able to read and understand questionnaires and informed consent
Show all 20Show fewer
  • Lives within 50 miles of the study site
  • Exclusion Criteria [These are listed in greater detail in the CIA Core]:
  • Any current DSM-V Axis I diagnosis except Alcohol, Cocaine, or Nicotine Use Disorder
  • Current or past substance dependence criteria other than cocaine, marijuana, or alcohol, smoking >1 pack of cigarettes per day
  • Current use of any psychoactive substance except cocaine, nicotine, and marijuana or medications as evidenced by self-report or urine drug screen
  • Current breath alcohol concentration >0.002
  • Positive urine drug screen for stimulants (including cocaine, amphetamine, methamphetamine, etc.) at the Scanning/Stimulation visits and signs of alcohol withdrawal. Based on the sensitivity of this test, this will require that the participants abstain from cocaine use for 48 hours prior to the intervention
  • History of seizures or migraine headaches
  • History of head trauma or epilepsy
  • Violation of other magnetic resonance imaging safety measures
  • Current suicidal or homicidal ideation
  • Presence of ferrous metal in the body, as evidenced by metal screening and self-report
  • Severe claustrophobia or extreme obesity that preclude placement in the MRI scanner
  • For female participants, pregnancy, as evidenced by a urine pregnancy test administered on the day of the scanning session

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: The Effects of a Single Session of Real Versus Sham Theta Burst Stimulation on the Brain Response to Drug-cues

High relapse rates among substance dependent individuals are likely due to a combination of factors that involve limbic circuits in the brain involved in craving, including vulnerability to salient cues. Emerging data suggests that non-invasive, targeted brain stimulation may be able to modulate activity in these circuits and decrease craving. The primary goal of this pilot study is to determine the extent to which a single session of continuous theta burst stimulation to the medial prefrontal cortex can attenuate limbic circuitry involved in craving among cocaine users and alcohol users. This will be tested through a double-blind,sham-controlled brain stimulation and brain imaging study in a cohort of polysubstance abusers and alcohol users.

Read the detailed description

This parent protocol contains two components - one of which is targeting cocaine users, the other of which is targeting heavy alcohol users (who will also serve as an appropriate control group for the cocaine users - who typically have comorbid alcohol use disorders). All participants will receive one session of real and one session of sham (randomized) continuous theta burst stimulation (TBS).TBS is a form of non-invasive transcranial magnetic stimulation (TMS).Continuous TBS is designed to lower cortical excitability, and requires a shorter stimulation period than typical low frequency TMS. The investigators will test the hypotheses that stimulation over the medial prefrontal cortex will attenuate activity in the medial prefrontal cortex (Aim 1), using single pulse TMS in the magnetic resonance imaging scanner. Through this innovative technique it is possible to apply a single pulse of TMS to the medial prefrontal cortex and model the hemodynamic response at the stimulation site as well as monosynaptic target regions, including the striatum. The investigators will also investigate the effect of TBS on neural response to drug cues (Aim 2). The results of these aims will be further correlated with self-reported assessments of craving throughout each experimental visit. These data will be preliminary data for a subsequent R01 focused on the sustained effects of multiple sessions of TBS and their efficacy in lowering craving for extended periods of time in treatment-seekers.

Being tested
Real continuous Theta Burst Stimulation, Sham continuous Theta Burst Stimulation
Keywords
Transcranial Magnetic Stimulation, Magnetic Resonance Imaging, MRI, Functional
Medical subject headings
Alcoholism, Cocaine-Related Disorders, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Real continuous Theta Burst StimulationDevice

    Continuous Theta Burst stimulation delivered

  • Sham continuous Theta Burst StimulationDevice

    active sham Continuous Theta Burst stimulation delivered

Study groups in NCT02939352
Study groupRoleWhat they receive
Cocaine UsersExperimentalParticipants will receive Real continuous Theta Burst Stimulation to the left frontal pole/medial prefrontal cortex. Participants will also receive Sham continuous Theta Burst Stimulation to the left frontal pole/medial prefrontal cortex.
Receives: Device: Real continuous Theta Burst Stimulation; Device: Sham continuous Theta Burst Stimulation
Alcohol UsersExperimentalParticipants will receive Real continuous Theta Burst Stimulation to the left frontal pole/medial prefrontal cortex. Participants will also receive Sham continuous Theta Burst Stimulation to the left frontal pole/medial prefrontal cortex.
Receives: Device: Real continuous Theta Burst Stimulation; Device: Sham continuous Theta Burst Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Medial Prefrontal Cortex (MPFC)

    Measured: 1 hour

Secondary outcomes (2)

  1. Self reported craving

    Tiffany Craving Scale

    Measured: 1 hour

  2. Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Striatum

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2016 (estimated)
  2. Study startSep 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02939352
Sponsor's protocol ID
30506
Acronym
addictionTBS
Status last verified
Jul 2018
First submitted
28 Sep 2015
Last updated
23 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kearney-Ramos TE, Dowdle LT, Lench DH, Mithoefer OJ, Devries WH, George MS, Anton RF, Hanlon CA. Transdiagnostic Effects of Ventromedial Prefrontal Cortex Transcranial Magnetic Stimulation on Cue Reactivity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 Jul;3(7):599-609. doi: 10.1016/j.bpsc.2018.03.016. Epub 2018 Apr 10.

    PubMed 29776789

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Real continuous Theta Burst Stimulation in people with Alcoholism and Cocaine Addiction, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Blood Oxygen-Level Dependent (BOLD) signal change in the Medial Prefrontal Cortex (MPFC) (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02939352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018.

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