Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000742077
Ethics application status
Approved
Date submitted
30/04/2010
Date registered
6/09/2010
Date last updated
6/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intranasal oxytocin for the treatment of cannabis and alcohol dependence
Scientific title
The effect of intranasal oxytocin on cannabis and associated alcohol cravings and withdrawal in patients diagnosed with cannabis and alcohol dependence
Secondary ID [1] 252638 0
nil
Universal Trial Number (UTN)
U1111-1114-8409
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis and alcohol dependence 257269 0
Condition category
Condition code
Mental Health 257417 257417 0 0
Addiction
Mental Health 258310 258310 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
40 international units of oxytocin intranasally twice per day for 4 weeks.
Intervention code [1] 256388 0
Treatment: Drugs
Comparator / control treatment
All placebo administration will be twice per day for 4 weeks in line with oxytocin administration. Placebo is administered intranasally and consists of the preservatives found in the active oxytocin nasal spray (i.e., chlorobutanol hemihydrate, E216, and E218).
Control group
Placebo

Outcomes
Primary outcome [1] 258333 0
Reduction in cannabis and associated alcohol craving and withdrawal using the following measures:

Cannabis Problems Questionnaire
Cannabis Use Disorders Identification Test - revised
Severity of dependence scale - cannabis
Marijuana Withdrawal Scale
Depression Anxiety Stress Scale - 21
K-10 depression scale
Social Interaction Anxiety Scale
Pittsburgh Sleep Quality Index
World Health Organisation Disability Assessment Schedule - II
Severity of Dependence Scale - alcohol
Alcohol Use Disorders Identification Test
Obsessive Compulsive Drinking Scale
Timepoint [1] 258333 0
Baseline, 4-week, 8-week.
Primary outcome [2] 259162 0
Diagnostic criteria for cannabis and alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders IV text revision.

Time-line follow back for assessing cannabis and alcohol consumption
Timepoint [2] 259162 0
Induction and 4 weeks post drug treatment.
Secondary outcome [1] 264053 0
Reduction in neurocognitive and psychosocial impairment using the Reading the Mind in the Eyes task, Eye-gaze to social cues task using TobiiStudio eye tracking technology, and the Movie Stills Task. These tasks are conducted using a computer and eye gaze technology.
Timepoint [1] 264053 0
Baseline, 4-week, 8-week.
Secondary outcome [2] 265495 0
We will also be assessing changes in biological functioning that include body mass index, blood plasma cortisol, vasopressin, and oxytocin using Enzyme Immunoassay and assessing heart rate and blood pressure.
Timepoint [2] 265495 0
Baseline, 4-week, 8-week.

Eligibility
Key inclusion criteria
Diagnostic and Statistical Manual for Mental Disorders-IV diagnostic criteria for cannabis and alcohol dependence.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Epilepsy
Severe depression with suicidal thoughts and/ or actions
Drug addiction (other than nicotine, cannabis, or alcohol)
Currently take medication and you are not stable on this medication (i.e., have been taking the medication for less than 4 weeks)
Are currently receiving psychological or pharmacological treatment for substance use problems
Kidney Disease- (i.e., kidney stones, recurrent bladder infections, or known kidney failure).
Severe liver disease (e.g., decompensated hepatic failure)
Sensitivity to preservatives (in particular E 216, E 218 and chlorobutanol hemihydrate).
Nasal obstruction, discharge, or bleeding
Cardiovascular problems (e.g., heart disease, history of heart attacks), high blood pressure (hypertension)
Habitually drink large volumes of water
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Advertisement and word-of-mouth. Allocation randomised by compounding chemist. The person deciding on participant inclusion will use numbered containers to allocate medication.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256892 0
University
Name [1] 256892 0
The University of Sydney
Country [1] 256892 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney NSW 2006
Country
Australia
Secondary sponsor category [1] 256164 0
None
Name [1] 256164 0
Address [1] 256164 0
Country [1] 256164 0
Other collaborator category [1] 1228 0
University
Name [1] 1228 0
University of New South Wales
Address [1] 1228 0
Randwick Campus
32 King Street
Randwick NSW 2031
Country [1] 1228 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258903 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 258903 0
Level 6
Jane Foss Russell Building G02
The University of Sydney NSW 2006
Ethics committee country [1] 258903 0
Australia
Date submitted for ethics approval [1] 258903 0
Approval date [1] 258903 0
29/04/2010
Ethics approval number [1] 258903 0
12055

Summary
Brief summary
This double-blind, randomised, placebo controlled trial will examine the safety and efficacy of intranasal oxytocin for the treatment of cannabis and alcohol dependence. It is hypothesised that participants randomised to the oxytocin condition, compared to participants randomised to the placebo condition will have a higher rate of treatment completion, experience reduced number, severity, and duration of cannabis and alcohol withdrawal symptoms and will report fewer days of cannabis and alcohol use at one month follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31110 0
Address 31110 0
Country 31110 0
Phone 31110 0
Fax 31110 0
Email 31110 0
Contact person for public queries
Name 14357 0
Dean Carson
Address 14357 0
100 Mallett Street
Camperdown
NSW 2050
Country 14357 0
Australia
Phone 14357 0
+61 2 9351 0793
Fax 14357 0
+61 2 9351 0652
Email 14357 0
[email protected]
Contact person for scientific queries
Name 5285 0
Dean Carson
Address 5285 0
100 Mallett Street
Camperdown
NSW 2050
Country 5285 0
Australia
Phone 5285 0
+61 2 9351 0793
Fax 5285 0
+61 2 9351 0652
Email 5285 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.