NCT01323569

Abuse Potential of Sativex

A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Abuse Potential of Sativex in Subjects With a History of Recreational Marijuana Use

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This crossover study with six treatment sessions is to evaluate the abuse potential of three doses of Sativex as compared to Marinol and placebo, in subjects with a history of recreational marijuana use.

Detailed description

Subjects attended a two-session, randomized, double-blind, crossover qualification in which they received the positive control drug (Marinol 30 mg) and matching placebo 48 hours apart in a randomized fashion. To qualify, subjects must have discriminated between Marinol and placebo. Eligible subjects then went on to the main study divided into six treatment sessions each separated by 7-21 days. Serial pharmacodynamic evaluations were taken at each treatment session as well as occasional pharmacokinetic blood samples to verify proof of exposure. In addition, safety monitoring included regular assessments of vital signs, telemetry, 12-lead ECG, clinical laboratory tests and adverse events (AEs).

Conditions

• Evaluation of Abuse Potential of Sativex

Interventions

Type	Name	Description
DRUG	Sativex	Sativex dose level 1: 10.8 mg THC/10 mg CBD (4 sprays) + 12 placebo sprays + 4 placebo capsules.
DRUG	Sativex	Sativex dose level 2: 21.6 mg THC/20 mg CBD (8 sprays) + 8 placebo sprays + 4 placebo capsules
DRUG	Sativex	Sativex dose level 3: 43.2 mg THC/40 mg CBD (16 sprays) + 4 placebo capsules
DRUG	Placebo	16 placebo sprays and 4 placebo capsules
DRUG	Marinol	Marinol dose level 1: 20 mg THC (2 marinol capsules) + 2 placebo capsules + 16 placebo sprays
DRUG	Marinol	Marinol dose level 2: 40 mg THC (4 marinol capsules) + 16 placebo sprays

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2011-03-25
• Last updated: 2023-04-10

Locations

1 site across 1 country: Canada