NCT05631548

Brief Summary

The purpose of this study is to assess the effects of active intermittent theta burst stimulation (iTBS) to dorsomedial prefrontal cortex (dmPFC) on electroencephalogram (EEG) measures of reward sensitivity and cue reactivity and cocaine craving in cocaine users

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2023

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

November 18, 2022

Results QC Date

December 6, 2023

Last Update Submit

January 3, 2024

Conditions

Cocaine Use Disorder

Keywords

Transcranial Magnetic Stimulation (TMS)

Outcome Measures

Primary Outcomes (4)

  • Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG

    The Doors Task will be used to elicit the Reward Potential (RewP) component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down. The amplitude of the RewP in microvolts in response to feedback is reported.

    Baseline (before iTBS session)

  • Amplitude of the Reward Potential (RewP) in Microvolts in Response to Feedback on the Doors Task as Assessed by EEG

    The Doors Task will be used to elicit the Reward Potential (RewP) component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up (win) or if they did not find the prize by a red arrow pointing down (loss). The amplitude of the RewP in microvolts in response to feedback is reported.

    Immediately after iTBS session

  • Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG

    The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and cocaine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.

    Baseline (before iTBS session)

  • Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by EEG

    The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and cocaine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.

    Immediately after iTBS session

Secondary Outcomes (6)

  • Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)

    Baseline(before iTBS session)

  • Craving as Assessed by the Minnesota Cocaine Craving Scale (MCCS)

    Immediately after iTBS session

  • Pain as Assessed by the Visual Analog Scale (VAS)

    Baseline(before iTBS session)

  • Pain as Assessed by the Visual Analog Scale (VAS)

    Immediately after iTBS session

  • Cognitive Function as Assessed by the Montreal Cognitive Assessment (MoCA)

    Baseline(before iTBS session)

  • +1 more secondary outcomes

Study Arms (2)

iTBS to dmPFC, Then Sham iTBS

EXPERIMENTAL
Device: iTBS to dmPFCDevice: Sham iTBS

Sham iTBS, Then iTBS to dmPFC

SHAM COMPARATOR
Device: iTBS to dmPFCDevice: Sham iTBS

Interventions

iTBS to dmPFCDEVICE

TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. Approximately 25% of the nasion-inion distance, or Talairah coordinates X 0 Y+60 Z+60 will be measured.The first session will begin with the acquisition of the resting motor threshold (rMT; lowest stimulus intensity that elicits a visible twitch on 50% of the trials) on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last about 3 minutes. Each participant will receive 2 sessions with a 15-20 minute interval between sessions.

Sham iTBS, Then iTBS to dmPFCiTBS to dmPFC, Then Sham iTBS
Sham iTBSDEVICE

Sham TMS will be delivered with the sham side of the MagVenture Cool B70 A/P coil. The software will be pre-programmed by a staff member that will not be involved in data analysis or collection for blinding purposes. The sham stimulation will match the number of pulses and length of time as the active condition and each participant will receive 2 sessions with a 15-20 min interval between sessions.

Sham iTBS, Then iTBS to dmPFCiTBS to dmPFC, Then Sham iTBS

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CUD diagnosis

You may not qualify if:

  • moderate or severe criteria for substances other than cocaine, cannabis, or nicotine
  • unstable psychiatric disorder
  • medical conditions contraindicated to TMS (e.g., medical implants, history of seizure or seizure disorder, medications lowering the seizure threshold, neurological conditions, moderate-to-severe heart disease)
  • pregnancy
  • hairstyles incompatible with the EEG net
  • head injury with loss of consciousness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Results Point of Contact

Title
Heather Webber, PhD
Organization
The University of Texas Health Science Center at Houston
Heather.E.Webber@uth.tmc.edu
713-486-2723

Study Officials

  • Heather Webber, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 30, 2022

Study Start

February 23, 2023

Primary Completion

August 2, 2023

Study Completion

August 2, 2023

Last Updated

January 31, 2024

Results First Posted

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)