10 Days of Theta Burst Stimulation as a Tool to Treat Cocaine Dependence

NCT ID: NCT03238859

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2019-06-07

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.

Detailed Description

Cocaine dependence is a particularly difficult substance use disorder to treat. There is currently a lot of scientific inertia focused on the development of novel, neural circuit based strategies for intervention. A prior NARC funded pilot project in non-treatment seeking cocaine users demonstrated that a single session of medial prefrontal cortex theta burst stimulation (MPFC cTBS) decreases baseline frontal-striatal activity in limbic regions and decreases neural responses to cocaine uses. The effects of a single session however, erode over the first few hours after treatment. Sustainable effects require multiple days of treatment. GOAL: The next steps in pursuing this as a novel treatment are to 1) apply it to treatment-engaged patients and 2) determine whether several sessions of cTBS will produce sustainable and clinically-meaningful changes in cocaine use among these patients.

DESIGN: Treatment-engaged cocaine users and heavy alcohol users will be randomized to receive 10 sessions of real or sham LTD-like MPFC cTBS. This will be achieved by leveraging our existing partnership with the MUSC Center for Drug and Alcohol Programs (CDAP) and the Veterans Administration Substance Abuse Treatment Center Program (SATC) - which both provide a 4 week intensive outpatient treatment program. MPFC cTBS will be given during weeks 2 and 3 of the program. Functional MRI data and clinical assessments will be acquired during weeks 1, 4, and at participant's 1 month and 2 month Accountability/Continuity visits. Hypothesis: real cTBS treatment will enhance clinical outcomes (Aim 1 - including retention rates, number of clean urine drug screens during CDAP treatment, relapse rates at 1 and 2 months) and will produce a sustainable decrease in neural reactivity to cocaine cues (Aim 2 - week 1 versus week 4, 1 month & 2 month follow ups).

Conditions

Cocaine Dependence; Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Real cTBS

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).

Group Type: EXPERIMENTAL

Real cTBS

Intervention Type: DEVICE

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

Sham cTBS

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).

Group Type: SHAM_COMPARATOR

Sham cTBS

Intervention Type: DEVICE

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

Interventions

Real cTBS

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

Intervention Type: DEVICE

Sham cTBS

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Colleen A Hanlon, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colleen A Hanlon, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Ralph H Johnson Veterans Medical Center

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

R21DA041610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00046438

Identifier Type: -

Identifier Source: org_study_id