NCT04336293

Brief Summary

The purpose of this study is to determine if synchronized transcranial magnetic stimulation is safe and tolerable in individuals with cocaine, opioid, or alcohol use disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration 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

March 20, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 7, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

March 20, 2020

Last Update Submit

January 12, 2024

Conditions

Cocaine AddictionOpioid AddictionAlcohol Addiction

Keywords

Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (3)

  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)

    Quality of Life Enjoyment and Satisfaction Questionnaire The Q-LES-Q-SF evaluates general activities that are assessed in the longer form of the Q- LES-Q. Each item uses a 5-point scale ranging from 1 (very poor) to 5 (very good). A total score is derived from 14 items with a maximum score of 70 and with higher scores indicating greater life satisfaction and enjoyment.

    6 weeks

  • substance specific craving

    self reported reactivity to associated cues with 8 items ranked 1-7--higher scores indicating greater craving/urges

    6 weeks

  • Social and Occupational Functioning Assessment Scale (SOFAS)

    The SOFAS is a global rating of current functioning ranging from 0 to 100, with lower scores representing lower functioning.

    6 weeks

Study Arms (2)

active

EXPERIMENTAL

active sTMS

Device: sTMS

sham

SHAM COMPARATOR

sham sTMS

Device: sham sTMS

Interventions

sTMSDEVICE

sTMS will be delivered following NeoSync guidelines using the device user manual

active
sham sTMSDEVICE

sham sTMS will be delivered following NeoSync guidelines using the device user manual

sham

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible male and female Veterans
  • between ages 18-70,
  • Veterans who currently meet criteria for SUD, and, if applicable, have stable treatment regimen (i.e., medications and/or therapy) for at least 6 weeks prior to study procedures
  • ongoing medications and psychotherapy will be allowed to continue unchanged during the study
  • for safety, participants must also meet established criteria for MRI exposure, which is implemented as a conservative measure given the novel application of sTMS in this population

You may not qualify if:

  • pregnancy/lactation,
  • history of moderate or severe traumatic brain injury,
  • current or prior neurologic disorder or lifetime history of
  • seizure disorder
  • CNS tumors
  • stroke
  • cerebral aneurysm,
  • unstable medical condition,
  • active suicidality as assessed with the Columbia-Suicide Severity Rating Scale
  • primary psychotic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

Related Publications (1)

  • Jampel J, Quinn MJ, Catalano JL, Benca-Bachman CB, Brick L, Philip NS, Swift RM, McGeary JE. Synchronised transcranial magnetic stimulation for substance use-disordered Veterans: protocol for the pilot sham-controlled acceptability trial. BMJ Open. 2023 Jan 30;13(1):e066175. doi: 10.1136/bmjopen-2022-066175.

    PMID: 36717148DERIVED

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related DisordersAlcohol-Related Disorders

Study Officials

  • John E McGeary, PhD

    Providence VA Medical Center, Providence, RI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blind
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: double blind, sham controlled RCT
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2020

First Posted

April 7, 2020

Study Start

September 7, 2021

Primary Completion

October 31, 2023

Study Completion

December 29, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)