Anterior cingulate stimulation for alcohol addictio

Phase 2

• Conditions: Alcohol Use Disorder; Mental Health - Addiction

• Registration Number: ACTRN12614000859684
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Capable of understanding and signing an informed consent
2. Meeting DSM-5 severe Alcohol Use Disorder, based on a structured clinical interview with a consultant psychiatrist.
3. Primary addiction is to alcohol
4. Scoring >7 on the obsessive compulsive drinking scale.
5. Patients must have failed to respond to at least one residential alcohol treatment programme, at least one anticraving medication, and at least one outpatient intervention with specialist alcohol services.
6. Patients must be seeking help for their alcohol use disorder, and be willing to cooperate with surgical and psychiatric follow up.
7. Patients may remain on antidepressant or antianxiety medication during the study, but drugs and doses must remain unchanged from 6 weeks prior to surgery until 12 weeks post-surgery.
8. Patients must have a supportive social network (minimum 1 person) that they will provide contact details for, and involve in pre-/post-surgery appointments.
9. Patients must respond to rTMS with reduced alcohol craving (>50% reduction in craving numeric rating scale), using blinded placebo controlled testing

Exclusion Criteria

1. History of epileptic seizures (except those associated with alcohol withdrawal)
2. Psychiatric disorders with psychotic symptoms or manic symptoms
3. Patients with pace makers/defibrillators
4. Patients who have contraindications for MRI
5. Female patients who are or intend to become pregnant
6. Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved).
7. Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability (safety laboratory tests, vital signs and reported adverse events will be used to assess safety and tolerability throughout the study). Adverse events that might be related to neuromodulation include reduction in sustained attention or seizures. [12 weeks];Alcohol craving self-rating (0-10 numeric rating scale) [12 weeks ]

Secondary Outcome Measures

Name	Time	Method
Measures of alcohol intake (Timeline Follow Back; breath alcohol measurements; carbohydrate deficient transferrin, GGT and MCV).[12 weeks];Mood ratings (MADRS, State and Trait Anxiety)[12 weeks]