NCT03607591

Brief Summary

The study evaluates the efficacy of 3 weeks of repetitive transcranial magnetic stimulation (rTMS), 5 sessions/weekly, in reducing cocaine consumption immediately after and within the 8 weeks following the treatment in addicted patients with cocaine use disorders (CUD) versus placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 8, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

April 13, 2018

Last Update Submit

July 8, 2020

Conditions

Cocaine Use Disorder

Keywords

rTMSCravingMood and cognitive behaviorSubstance-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Cocaine intake

    Baseline was defined as cocaine consumption before randomization (visit 0). Baseline will be determined using an urine drug test.Changes from baseline to week 8 in cocaine intake

    8 weeks following the treatment

Secondary Outcomes (2)

  • Craving first measure

    8 weeks following the treatment

  • Craving second measure

    8 weeks following the treatment

Study Arms (2)

Active rTMS group

ACTIVE COMPARATOR

One daily session: active 15Hz frequency, pulse intensity 100% of the rTMS, 60 pulses per train, inter-train pause of 15 sec, 40 stimulation trains for a total of 2400 pulses in 13 min of stimulation). 15 sessions (3 weeks of 5 consecutive daily sessions and 2 days of rest)

Other: rTMS

Placebo rTMS group

PLACEBO COMPARATOR

One daily session: inactive 15Hz frequency, pulse intensity 100% of the rTMS, 60 pulses per train, inter-train pause of 15 sec, 40 stimulation trains for a total of 2400 pulses in 13 min of stimulation). 15 sessions (3 weeks of 5 consecutive daily sessions and 2 days of rest)

Other: rTMS

Interventions

rTMSOTHER

rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC

Active rTMS groupPlacebo rTMS group

Eligibility Criteria

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

You may qualify if:

  • male and female patients between 18 and 65 years of age
  • patients who meet the criteria for CUD reported in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V)
  • positivity to cocaine use, determined via an urine drug test
  • patients who are able to provide a written informed consent, after being notified about the treatment and the study protocol

You may not qualify if:

  • major depression disorder, schizophrenia, bipolar disorder or other psychosis that meet the diagnostic criteria of the DSM-V
  • illiteracy or cognitive impairment disorders
  • women who are pregnant or lactating
  • other medical diseases that contraindicate rTMS treatment such as epilepsy
  • presence of devices, i.e. pace-makers or cochlear prosthesis
  • previous rTMS treatments in order to avoid confounding factors
  • patients who can not provide the written informed consent
  • DSM-V substance use disorders other than CUD. Only tobacco smoke is allowed to be recruited in the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Careggi

Florence, 50134, Italy

Location

Related Publications (1)

  • Lolli F, Salimova M, Scarpino M, Lanzo G, Cossu C, Bastianelli M, Occupati B, Gori F, Del Vecchio A, Ercolini A, Pascolo S, Cimino V, Meneghin N, Fierini F, D'Anna G, Innocenti M, Ballerini A, Pallanti S, Grippo A, Mannaioni G. A randomised, double-blind, sham-controlled study of left prefrontal cortex 15 Hz repetitive transcranial magnetic stimulation in cocaine consumption and craving. PLoS One. 2021 Nov 16;16(11):e0259860. doi: 10.1371/journal.pone.0259860. eCollection 2021.

    PMID: 34784373DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

April 13, 2018

First Posted

July 31, 2018

Study Start

January 8, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Locations

IT(1)