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
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