Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000365066
Ethics application status
Approved
Date submitted
4/05/2010
Date registered
7/05/2010
Date last updated
7/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Hair drug analysis to identify cases of drug-facilitated sexual assault
Scientific title
Hair drug analysis to identify cases of drug-facilitated sexual assault
Secondary ID [1] 251685 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug facilitated sexual assault 257282 0
Condition category
Condition code
Other 257429 257429 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Using hair as a biological sample to test for drugs known to be identified in drug-facilitated sexual assault. Hair is analysed by gas chromatography/mass spectrometry for gamma hydroxy butyrate (GHB) and by liquid chromatography/mass spectrometry for other drugs.
People in whom drug facilitated sexual assault is suspected will be asked to provide 2 samples of hair (collected by examiner) about a pencil thickness each. This will be taken at 4-12 weeks after alleged sexual assault. One sample will be analysed for GHB and the other sample will be used for the other drugs.
This will be in addition to blood and urine samples taken as determined by the Sexual Assault Service protocols.
Hair samples will be collected, stored and analysed in batches over a 2 year period which is the duration calculated to recruit 100 participants.
Intervention code [1] 256419 0
Diagnosis / Prognosis
Comparator / control treatment
Currently, urine and blood are the biological samples routinely used to identify drugs that may be involved in drug-facilitated sexual assault.
Each participant will undergo hair testing. Blood and urine testing will also be done in the participant if it would normally be done as per Sexual Assault Service guidelines ie Blood sample if presentation within 24 hours of alleged sexual assault and urine sample if presentation within one week.
Blood and urine samples undergo screening, identification and quantitation for basic drugs (eg benzodiazepines, narcotic analgesics, anti-histamines, alcohol, etc) by gas chromatography and mass spectrometry or liquid chromatography and mass spectrometry. Additionally, the samples undergo an enzyme linked immunosorbent assay (ELISA) for some amphetamines, morphine and cannabinoids.
Samples will be collected, stored and analysed in batches over a 2 year period which is the duration calculated to recruit 100 participants.
Control group
Active

Outcomes
Primary outcome [1] 258350 0
Identification of drugs by hair analysis that aren't identified by urine or blood analysis
Timepoint [1] 258350 0
Blood and/or urine samples collected for analysis at initial point of contact.
Hair samples collected for analysis at 4-12 weeks after alleged drug-facilitated sexual assault.
Secondary outcome [1] 264084 0
Identifying drugs involved in suspicions of drug-facilitated sexual assault in the South Australian population.
Timepoint [1] 264084 0
Blood and/or urine samples collected for analysis at initial point of contact.
Hair samples collected for analysis at 4-12 weeks after alleged drug-facilitated sexual assault.
Secondary outcome [2] 264085 0
To identify which drugs may have improved detection with hair drug analysis
Timepoint [2] 264085 0
Blood and/or urine samples collected for analysis at initial point of contact.
Hair samples collected for analysis at 4-12 weeks after alleged drug-facilitated sexual assault.
Secondary outcome [3] 264086 0
To identify time frames for identification of drugs involved in drug-facilitated sexual assault in different biological specimens
Timepoint [3] 264086 0
Blood and/or urine samples collected for analysis at initial point of contact.
Hair samples collected for analysis at 4-12 weeks after alleged drug-facilitated sexual assault.

Eligibility
Key inclusion criteria
Attending the Yarrow Place Rape and Sexual Assault Service
Alleged or concern of sexual assault
Participant belief or concern and/or clinical suspicion of drug facilitation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who are bald.
People undergoing chemotherapy or radiotherapy involving the head.
Inability to attend follow-up visit

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256907 0
Government body
Name [1] 256907 0
National Drug Law Enforcement Research Fund
Country [1] 256907 0
Australia
Primary sponsor type
Individual
Name
Tanya Boast
Address
Lyell McEwin Health Service,
Haydown Road,
Elizabeth Vale, SA 5112
Country
Australia
Secondary sponsor category [1] 256179 0
None
Name [1] 256179 0
Address [1] 256179 0
Country [1] 256179 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258915 0
Ethics committee address [1] 258915 0
Ethics committee country [1] 258915 0
Date submitted for ethics approval [1] 258915 0
Approval date [1] 258915 0
Ethics approval number [1] 258915 0
REC2246/2/13

Summary
Brief summary
The purpose of this study is to compare hair drug analysis with urine and blood drug analysis which is currently used for investigating allegations of drug facilitated sexual assault (DFSA). Our hypothesis is that hair drug analysis will detect additional drugs than those detected in urine and blood samples.
In addition, we hope to document drugs involved in suspicions of DFSA in the South Australian population, identify which drugs may have improved detection with hair toxicology and document time frames for drug detection in different biological specimens.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31121 0
Address 31121 0
Country 31121 0
Phone 31121 0
Fax 31121 0
Email 31121 0
Contact person for public queries
Name 14368 0
Dr Tanya Boast
Address 14368 0
Lyell McEwin Health Service,
Haydown Road,
Elizabeth Vale SA 5112
Country 14368 0
Australia
Phone 14368 0
+61 8 8182 9279
Fax 14368 0
Email 14368 0
[email protected]
Contact person for scientific queries
Name 5296 0
Dr Tanya Boast
Address 5296 0
Lyell McEwin Health Service,
Haydown Road,
Elizabeth Vale SA 5112
Country 5296 0
Australia
Phone 5296 0
+61 8 8182 9279
Fax 5296 0
Email 5296 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.