Safety Assessment of Two Popular Legal Party Drugs: BZP and BZP+TFMPP

Phase 2

Recruiting

• Conditions: Subjects who have used BZP or BZP+TFMPP on at least 3 previous occasions; Other -

• Registration Number: ACTRN12606000504516
• Lead Sponsor: Ministry of Health New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). [Tested 1.5 hours and 4.5 hours after intervention];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.[On third day after intervention]

Secondary Outcome Measures

Name	Time	Method
For driving performance secondary outcomes include speed of driving, number of times out of lane, ability to track a leading car.[Assessments 1.5 and 4.5 hours after intervention. ];Mood and attention[Assessed 1, 3 and 72 hours after intervention.];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.[];Sleepiness[Assessed every 24 hours for 7 days.]