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

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.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000504516

Acronym

BESS1

Enrollment

Registered

2006-12-06

Start date

2006-03-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Legal party pills or 'herbal highs' are commonly used as recreational drugs in New Zealand. They contain the chemicals BZP (1-benzylpiperazine) and TFMPP (trifluoromehtylphenylpiperazine) and are often taken with alcohol. This study is the first to look at how party pills, with and without alcohol, affect driving performance. It also aims to clarify the effects of party pills on attention, mood and sleep. This clinical trial therefore provides important new information on the safety of party pills.

Interventions

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 juic

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Educational / counselling / training

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results