NCT03238859

Brief Summary

The goal of this double-blind sham controlled study is to evaluate the effeicacy of continuous theta burst stimulation to the frontal pole as a tool to decrease drug cue reactivity and improve treatment outcomes in treatment-engaged cocaine and alcohol users. All participants will be randomized to receive 10 days of real or sham rTMS to the frontal pole. Brain imaging data and behavioral assessments will be collected at 4 time points - before TMS, after 10 days of TMS, 1 month follow up and 2 month follow up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 1, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2019

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

September 1, 2016

Last Update Submit

March 10, 2020

Conditions

Cocaine DependenceAlcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Change in Drug cue reactivity

    The effect of real versus sham cTBS on drug cue reactivity will be assessed by comparing the brain activity in the limbic system

    Baseline visit and 1 month follow up

Secondary Outcomes (1)

  • Number of Clean Urine Drug Screens

    1 month and 2 month follow up

Study Arms (2)

Real cTBS

EXPERIMENTAL

10 days of real cTBS treatment will be given (3600 pulses to the left frontal pole as defined by EEG coordinate: FP1; 60 second pause after 1800 pulses; 110% RMT including a 30 second initial ramp period 80%-110% RMT; Magventure MagPro X100 Cool Coil).

Device: Real cTBS

Sham cTBS

SHAM COMPARATOR

10 days of sham cTBS treatment will be given (3600 pulses to the left frontal pole as defined by EEG coordinate: FP1; 60 second pause after 1800 pulses; 110% RMT including a 30 second initial ramp period 80%-110% RMT; Magventure MagPro X100 Cool Coil).

Device: Sham cTBS

Interventions

Real cTBSDEVICE

This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)

Real cTBS
Sham cTBSDEVICE

This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)

Sham cTBS

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals from 21-65 years old currently enrolled in an intensive outpatient treatment program.

You may not qualify if:

  • Participants will be excluded if they are not between 21-65 years old, have current or prior dependence (DSM-IV, because a DSM-V version of the SCID is not yet available) on prescription or psychoactive drugs other than cocaine, alcohol, or nicotine but including marijuana; past 6 month abuse of any prescription or psychoactive drugs excluding cocaine, marijuana, alcohol or nicotine, lifetime history of head injury with loss of consciousness, being pregnant or breast feeding, unstable medical illness (e.g., hypertension, diabetes, myocardial infarction), presence of ferromagnetic metal in their body, history of seizures. Additionally, to mitigate any potential risk of seizures. As mentioned above, all participants will receive the Clinical Institute Withdrawal Assessment of Alcohol (CIWAar) assessment before each TMS visit. Individuals with a CIWA score \>5 will be excused from the study. All individuals with a history of medical detoxification or hospitalization for AUD (per the Assessments listed above), self-reported alcohol withdrawal seizures, or delirium tremens will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Ralph H Johnson Veterans Medical Center

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Officials

  • Colleen A Hanlon, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 1, 2016

First Posted

August 3, 2017

Study Start

August 1, 2016

Primary Completion

June 7, 2019

Study Completion

June 7, 2019

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared. All data is deidentified.

Locations

US(2)