Effects of neurofeedback on Cannabis Use Disorder (CUD)

• Register: ISRCTN
• Last refreshed on: 8 January 2018
• Main ID: ISRCTN25526593
• Date of registration: 01/12/2017
• Prospective Registration: No
• Primary sponsor: Geneva University Hospitals - Addiction Unit
• Public title: Effects of neurofeedback on Cannabis Use Disorder (CUD)
• Scientific title: Neurofeedback for Cannabis Use Disorder: a pilot study on clinical effects and possible relationship with brain dopamine function
• Date of first enrolment: 17/08/2017
• Target sample size: 51
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN25526593
• Study type: Interventional
• Study design: Pilot randomized parallel-group open controlled study (Treatment)

Countries of recruitment

Switzerland

Contacts

• Name: Yasser Khazaal

Key inclusion & exclusion criteria

Inclusion criteria: 1. 34 patients with DSM-5 Diagnosis of Cannabis Use Disorder (CUD)
2. 17 sex and age-matched healthy controls
3. Aged between 18 and 50 years inclusive
4. Informed consent
5. Available to complete the study
6. Negative serum pregnancy test at screening (for women of childbearing potential)
Exclusion criteria: 1. Psychiatric disorder (other than CUD in CUD patients)
2. Neurological disorder
3. Significant medical condition such as cancer, liver disease, hepatic impairment, renal disease, neuroleptic malignant syndrome, non-traumatic rhabdomyolysis, pheochromocytoma, or glaucoma
4. Current treatment with antipsychotic or benzodiazepine or monoamine oxidase inhibitor
5. Metal implant
6. Participation in a research/clinical study involving radiation exposure in the past 12 months
7. Pregnancy
8. Breastfeeding
9. Lack of safe contraception

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cannabis use disorder
Mental and Behavioural Disorders
Mental and behavioural disorders due to use of cannabinoids

Intervention(s)

This is an pilot, randomized, parallel-group, open controlled study that aims to compare the effects of EEG-NFB as an additive intervention to conventional treatments (treatments as usual: TAU), on levels of cannabis use, drug craving, anhedonia in patients with a cannabis use disorder. The study is thus designed with two parallel treatment groups of patients with CUD for the evaluation of the two treatments. Patients with CUD will be randomly assigned to an experimental (n=17) or a control group (n=17). Concealed randomization will be made by an independent research assistant using sequentially numbered, opaque, sealed envelopes. The envelopes will each receive a number in advance (from 1 to 30), and will be opened sequentially, only after the participant’s name is written on the appropriate envelope.

1. The experimental CUD group (or TAU+NFB group) will receive thirty 30-min sessions of EEG-based NFB in addition to treatment as usual (TAU) spread over a 2-month period. Each NFB session will consist of 30-minutes of training at home, with a frequency of 5 sessions per week
2. The control CUD group (or TAU group) will receive TAU only as a comparator. Standard TAU in both groups will consist of
individual outpatient treatment on a weekly basis

Follow-up assessment is planned at two months after the end last day of their respective treatment.

Moreover, the study will be complemented by a case-control group of 17 healthy volunteers (i.e. non-cannabis users) to directly investigate the abnormalities associated with CUD in terms of brain dopamine synthesis capacity, EEG spectral profile and neuropsychological variables related to impulsivity. The three tasks used in the present study to appraise different psychological patterns tied with impulsive behavior. Impulsive action is usually investigated using tasks that measure response inhibition such as the Stop-Signal Task whereas impulsive decision-making has primarily been investigates using the Delay Discounting Ta

Primary Outcome(s)

1. Cannabis use, measured using the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
2. DA synthesis capacity and storage, measured using [18F]-FDOPA Ki uptake values (6-fluoro-L-DOPA (or Fluorodopa)

Measured at baseline (including PET scan), within one week of the two months treatment (including PET scan) and at two months follow-up (excluding PET scan)

Secondary Outcome(s)

1. Time to smoke 1 gram of cannabis
2. Total scores on the Craving Experience Questionnaire and on the Dimensional Anhedonia Rating Scale
3. Theta/alpha power EEG measure
4. Stop-signal reaction time in the Stop Signal Task
5. Equivalence point in the Delay-Discounting Task
6. Average number of pumps delivered in the Balloon Analogue Risk Task

Measured at baseline (including PET scan), within one week of the two months treatment (including PET scan) and at two months follow-up (excluding PET scan)

Secondary ID(s)

2017-00391

Source(s) of Monetary Support

The HUG (Geneva University Hospitals) Private Foundation