Condition category
Mental and Behavioural Disorders
Date applied
09/05/2015
Date assigned
13/05/2015
Last edited
16/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cocaine is a highly addictive stimulant drug. Regular users of cocaine are at risk of developing cocaine use disorder (CUD), a common substance abuse disorder linked to numerous health problems. Regular cocaine use, as seen in CUD, has been shown to cause damaging changes to the prefrontal cortex (PFC) brain region. Damage to the PFC leads to loss of inhibitory control. This means affected people are less able to stop themselves from taking drugs, and exhibit what is called ‘drug seeking behaviour’. Loss of inhibitory control is an important factor in the development of drug addiction. Despite the numerous problems associated with CUD, no effective pharmacological (drug) or psychological therapies have been developed to successfully treat it. There is some evidence to suggest that a process called repeated transcranial magnetic stimulation (rTMS) of the PFC may help to reduce drug seeking behaviour. rTMS is a noninvasive and relatively painless way to stimulate specific areas of the brain using magnetic fields generated by an electromagnetic coil placed against the head. rTMS is currently used in the treatment of a variety of mood disorders, including depression, with good results. The aim of this study is to see how well rTMS works to reduce drug seeking behaviour in adults diagnosed with CUD.

Who can participate?
Adults diagnosed with cocaine dependency.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) are given 8 rTMS treatments once a day for the first five days, then once a week for the following three weeks. Those in group 2 (control group) are given standard daily pharmacological treatment. All participants take part in the study for 29 days. At the end of the 29-days, a 63-day follow-up phase takes place during which participants are offered to continue with the same treatment, or switch to the other treatment. Participants are asked to provide urine samples and answer questionnaires during the study and follow up period.

What are the possible benefits and risks of participating?
All participants receive a treatment for their disease. There is no risk of physical injury or harm associated with participating in this study. Both treatments are well known, and exclusion criteria have been established to reduce any possible side effects.

Where is the study run from?
Hospital of Padova Neurology Clinic (Clinica Neurologica dell’Azienda Ospedaliera di Padova) (Italy)

When is the study starting and how long is it expected to run for?
September 2013 to May 2015

Who is funding the study?
1. Hospital of Padova Neurology Clinic (Clinica Neurologica - Azienda Ospedaliera di Padova) (Italy)
2. Novella Fronda Foundation - ONLUS (Italy)

Who is the main contact?
Prof L Gallimberti
studio@studiogallimberti.it

Trial website

Contact information

Type

Public

Primary contact

Dr Luigi Gallimberti

ORCID ID

Contact details

Piazza Castello 16
Padova
35141
Italy
+39 (0)392 9247378
studio@studiogallimberti.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3165/AO/14

Study information

Scientific title

Pilot study on reducing the craving for a group of COCAine-dependent patients treated with repetitive transcranial magnetic stimulation (rTMS)

Acronym

COCA

Study hypothesis

Prefrontal cortex (PFC) stimulation via repetitive transcranial magnetic stimulation (rTMS) might be an effective therapeutic treatment in preventing cocaine use.

Ethics approval

Ethics Committee for Clinical Research of the Province of Padova - Padova Hospital (Comitato Etico per la Sperimentazione Clinica della Provincia di Padova – Azienda Ospedaliera di Padova), 05/06/2014, ref: 3165/AO/14.

Study design

Between-subject open-label randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Cocaine use disorder (CUD)

Intervention

1. Group 1 (intervention group) will be treated with rTMS (MagVenture MagPro 30 model, B-70 Cool coil). The standards used for the stimulation were the following: 15 Hz frequency, impulse intensity equal to 100% of the rMT, 60 impulses per stimulation train, intertrain pause of 15 seconds, 40 stimulation trains, 2400 total impulses for a total duration of 13 minutes.
2. Group 2 (control group) will be treated with a standard protocol used for many years at the Department of Neurology where the study was conducted in Padua, Italy. This protocol includes pharmacological treatment with pramipexole 0.35 mg t.i.d., bupropione 150 mg daily, oxazepam 15 mg t.i.d., triazolam 0.25 mg daily and gamma hydroxybutyrate 1.75 gram daily.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Use of cocaine assessed by either positive or negative urine drug screen test for cocaine compared in the rTMS versus control groups.

Secondary outcome measures

Craving for cocaine using a 0-10 Visual Analogue Scale.

Overall trial start date

01/09/2013

Overall trial end date

07/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of current cocaine use disorder (CUD) based on the DSM-5
2. Seeking treatment for cocaine use

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

1. Pregnancy
2. Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, psychosis or other psychiatric disorders
3. Diagnosis of current alcohol and/or substance use disorder (except for cocaine and smoking) based on the DSM-5
4. Diagnosis of epilepsy/seizure
5. Presence of devices, e.g. pace-makers, cochlear prosthesis, neuro-stimulators, magnetic cochlear prosthesis, intraocular metallic fragments

Recruitment start date

01/08/2014

Recruitment end date

01/02/2015

Locations

Countries of recruitment

Italy

Trial participating centre

Hospital of Padova Neurology Clinic (Clinica Neurologica dell’Azienda Ospedaliera di Padova)
Outpatient Clinic Via Giustiniani, 2
Padova
35128
Italy

Sponsor information

Organisation

Hospital of Padova Neurology Clinic (Clinica Neurologica - Azienda Ospedaliera di Padova)

Sponsor details

Via Giustiniani
2
Padova
35128
Italy
+39 (0)49 8213600
cl.neurologica@sanita.padova.it

Sponsor type

Hospital/treatment centre

Website

http://www.sanita.padova.it/reparti/neurologia,1001,35

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital of Padova Neurology Clinic (Clinica Neurologica - Azienda Ospedaliera di Padova) (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novella Fronda Foundation - ONLUS (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to disseminate the data (primary and secondary outcomes) in a peer-review Journal. We hope to have a paper accepted for publication by the end of the year.

Intention to publish date

01/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26655188

Publication citations

Additional files

Editorial Notes