Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000372785
Ethics application status
Not yet submitted
Date submitted
31/03/2013
Date registered
8/04/2013
Date last updated
8/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot investigation of the effects of Baclofen on a quantitative electroencephalographic predictor of relapse to alcohol dependence.
Scientific title
An investigation of the effects of Baclofen on the amount of high frequency beta activity during quantitative electroencephalography in alcohol dependent participants.
Secondary ID [1] 282222 0
NIL
Universal Trial Number (UTN)
U1111-1141-2852
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder 288739 0
Condition category
Condition code
Mental Health 289095 289095 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baclofen tablets 5mg three times a day for three days then Baclofen tablets 10mg three times a day for three weeks. Urine drug screen after three weeks and three days
Intervention code [1] 286835 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289204 0
Amount of High frequency beta activity on quantitative electroencephalogram
Timepoint [1] 289204 0
After three weeks of 10mg three times a day therapy with baclofen tablets
Secondary outcome [1] 302028 0
Risk of relapse to heavy alcohol use. Quantitative electroencephalogram high frequency beta activity is a marker of frontal lobe dysfunction and associated with increased relapse to heavy alcohol use
Timepoint [1] 302028 0
On completion of three weeks baclofen 10mg three times daily therapy

Eligibility
Key inclusion criteria
Severe Alcohol Use Disorder
Abstinent from alcohol for 1 week
Willing and able to provide informed consent to participate in the study
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Opiate, Stimulant, Inhalant or Benzodiazepine dependence
2. History of dementia or severe brain injury or Mini Mental score < or = 26/30
3. Receiving baclofen or diazepam medication in the 5 days prior to the study
4. Receiving any regular medication which may significantly change EEG activity including anticonvulsants, benzodiazepines or other sedatives. (This specifically does not include oral contraceptives, thiamine, multivitamins, thyroxine, naltrexone, nicotine replacement therapy or antidepressants.)
5. Acamprosate ( A medication for alcohol dependence which has a mechanism of action which could interact with the mechanism of action of Baclofen)
6. Renal function where creatinine clearance is less than 50ml/min.
7. Pregnancy or breast feeding
8. History of intolerance to baclofen
9. Contraindications/precautions ( as listed in the product information) to baclofen
10. Past history of major medical condition.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutive informed volunteers will be enrolled in this trial. Subjects will be adults who have a history of alcohol dependence. Subjects will be recruited from a public substance withdrawal unit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pearson’s Correlation Coefficient will be used to measure relationships between normally distributed continuous variables. Where data are normally distributed, differences between groups will also be identified by Student’s t-tests. These will be used to establish the effectiveness of baclofen in reducing cognitive impairment during alcohol withdrawal in alcohol dependent people. Other exploratory analyses will be aimed at identifying the relationship of the results of baclofen use and the additional variables recorded. Where the relationship between baclofen and other variable is binary (yes/no) logistic regression will be used. For example for gender the odds of sub range levels comparing males and females will be compared.
This is a pilot study which is designed to establish the effectiveness of this research method. One prior study using this method was able to demonstrate significant results with 16 participants so this study is expected to have useful results with 20 participants

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2013
Actual
Date of last participant enrolment
Anticipated
31/05/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 844 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 6639 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 286983 0
Self funded/Unfunded
Name [1] 286983 0
Dr Matt Gaughwin
Country [1] 286983 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Tce, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 285771 0
None
Name [1] 285771 0
Address [1] 285771 0
Country [1] 285771 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289032 0
Human Research Ethics Committee Royal Adelaide Hospital
Ethics committee address [1] 289032 0
Level 3, Hanson Institute (IMVS Building)
Royal Adelaide Hospital
North Tce
Adelaide
SA 5000
Ethics committee country [1] 289032 0
Australia
Date submitted for ethics approval [1] 289032 0
03/04/2013
Approval date [1] 289032 0
Ethics approval number [1] 289032 0

Summary
Brief summary
Alcohol Dependence is a disorder with multiple adverse health and social impacts. Recent research has suggested that some of the ongoing tendency for relapse to heavy drinking is a consequence of pre frontal lobe dysfunction. An established marker of this dysfunction is high frequency beta electroencephalogram dysfunction. This pilot trial is designed to establish if the medication, baclofen, reduces this electroencephalographic marker. This medication has been used widely for this purpose in Australia and other countries based on empirical observations of its benefit for alcohol dependence. This study will hopefully further elucidate its mechanism of action in this condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38882 0
Dr Philip Crowley
Address 38882 0
Drug & Alcohol Resource Unit
Royal Adelaide Hospital
North Tce
Adelaide
SA 5000
Country 38882 0
Australia
Phone 38882 0
61 08 83730888
Fax 38882 0
61 08 83732092
Email 38882 0
[email protected]
Contact person for public queries
Name 38883 0
Dr Philip Crowley
Address 38883 0
Drug & Alcohol Resource Unit
Royal Adelaide Hospital
North Tce
Adelaide
SA 5000
Country 38883 0
Australia
Phone 38883 0
61 08 83730888
Fax 38883 0
61 08 83732092
Email 38883 0
[email protected]
Contact person for scientific queries
Name 38884 0
Dr Philip Crowley
Address 38884 0
Drug & Alcohol Resource Unit
Royal Adelaide Hospital
North Tce
Adelaide
SA 5000
Country 38884 0
Australia
Phone 38884 0
61 08 83730888
Fax 38884 0
61 08 83732092
Email 38884 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.