Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000504516
Ethics application status
Approved
Date submitted
21/02/2006
Date registered
6/12/2006
Date last updated
6/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety Assessment of Two Popular Legal Party Drugs: BZP and BZP+TFMPP
Scientific title
A randomised placebo controlled trial to evaluate the effects of a benzylpiperazine (BZP) and trifluoromethylphenylpiperazine (TFMPP) combination "party pill" with and without alcohol on driving performance in subjects who have used BZP or BZP+TFMPP on at least 3 previous occasions.
Universal Trial Number (UTN)
Trial acronym
BESS1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjects who have used BZP or BZP+TFMPP on at least 3 previous occasions 1482 0
Condition category
Condition code
Other 1576 1576 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions will be given blinded on the morning of the testing day to each subject: 2 caspules and 3 drinks at time = 0 and again at time = 2 hours. Each subject will be randomly allocated one of the following 4 options:
1. Placebo capusles + orange juice (alcohol control)
2. Capsules containing a combination of 270mg BZP + 70mg TFMPP ("E-formula") + orange juice
3. Placebo capsules + vodka (6 units) + orange juice
4. BZP + TFMPP combination capsules (as above) + vodka (6 units) + orange juice
A unit of vodka = 30mls 'Absolut' vodka
Quantity of orange juice = 290mls
Placebo capsules contain lactose +114mg thiamine.
Intervention code [1] 907 0
Behaviour
Comparator / control treatment
Placebo capsules
Control group
Placebo

Outcomes
Primary outcome [1] 2179 0
Hypothesis is that BZP+TFMPP will result in an unsafe driving performance which can be detected using a driving simulator. Primary outcome variable is standard deviation of lateral position (SDLP).
Timepoint [1] 2179 0
Tested 1.5 hours and 4.5 hours after intervention
Primary outcome [2] 2180 0
Another hypothesis is that the party pill combination adversely affect psychological and physiological functioning. Primary outcome variables for these aspects of study are confusion score, body temperature, heart QTc and Stanford Sleepiness score.
Timepoint [2] 2180 0
On third day after intervention
Secondary outcome [1] 3799 0
For driving performance secondary outcomes include speed of driving, number of times out of lane, ability to track a leading car.
Timepoint [1] 3799 0
Assessments 1.5 and 4.5 hours after intervention.
Secondary outcome [2] 3800 0
Mood and attention
Timepoint [2] 3800 0
Assessed 1, 3 and 72 hours after intervention.
Secondary outcome [3] 3801 0
Other psychological and physiological tests after 1 and 3 hours including Vital signs, ECG, temperature, tremor, nystagmus, pupil size, myoclonus/fasiculations, urinary retention, feelings of nausea and palpitations Profile of Mood States (POMS), Digit-Symbol Substitution Test of the Wechsler Adult Intelligence Scale, and Conner's Continuous Performance Test II Computer Program.
Timepoint [3] 3801 0
Secondary outcome [4] 3802 0
Sleepiness
Timepoint [4] 3802 0
Assessed every 24 hours for 7 days.

Eligibility
Key inclusion criteria
Used BZP or BZP+TFMPP on at least 3 previous occasions with no major adverse effects, consumes alcohol, friend of family member able to accompany on day of testing.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Had a negative experience with BZP/TFMPP, psychiatric problems, taking medication that affects serotonin/dopamine, taking MAOIs [such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate)] in the last 14 days, epilepsy, asthma, high blood pressure, glaucoma, hyperthyroidism or other thyroid disorders, diabetes, difficulty micturating due to prostatic enlargement, pregnant, breastfeeding, cardiovascular disease, no valid drivers licence, lactose intolerant, cannot guarantee to avoid tomacco smoking on day of testing, cannot guarantee to avoid use of any recreational drugs from 48 hours before testing day until one week later.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Subjects, assessor and data analyst are blinded to the treatment
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 285 0
New Zealand
State/province [1] 285 0

Funding & Sponsors
Funding source category [1] 1720 0
Government body
Name [1] 1720 0
Ministry of Health
Country [1] 1720 0
Funding source category [2] 1721 0
Government body
Name [2] 1721 0
Health Research Council
Country [2] 1721 0
Primary sponsor type
Government body
Name
Ministry of Health New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 1518 0
Government body
Name [1] 1518 0
Health Research Council of New Zealand
Address [1] 1518 0
Country [1] 1518 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3178 0
Central Regional Ethics Committee
Ethics committee address [1] 3178 0
Ethics committee country [1] 3178 0
New Zealand
Date submitted for ethics approval [1] 3178 0
Approval date [1] 3178 0
Ethics approval number [1] 3178 0
CEN/05/12/095

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35170 0
Address 35170 0
Country 35170 0
Phone 35170 0
Fax 35170 0
Email 35170 0
Contact person for public queries
Name 10096 0
Dr Imogen Thompson
Address 10096 0
Medical Research Institute of New Zealand
Level 3
99 The Terrace
PO Box 10055
Wellington
Country 10096 0
New Zealand
Phone 10096 0
+64 4 4729199
Fax 10096 0
Email 10096 0
[email protected]
Contact person for scientific queries
Name 1024 0
Dr Imogen Thompson
Address 1024 0
Medical Research Institute of New Zealand
Level 3
99 The Terrace
PO Box 10055
Wellington
Country 1024 0
New Zealand
Phone 1024 0
+64 4 4729199
Fax 1024 0
Email 1024 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.