drugset / Trial / NCT01323569

Abuse Potential of Sativex

NCT01323569 ↗

Phase 1 Completed 58 enrolled Jazz Pharmaceuticals
RandomizedCrossoverQuadruple-blindBasic science

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.

Timeline

Start
2008-02
Primary completion
2008-06
Completion
2008-06

Outcome

Mixed primary results

paper Nabiximols 10.8 mg was not significantly different from placebo on primary measures but was different on some secondary measures. PMID 21671456 ↗

paper Nabiximols 21.6 mg was significantly greater than placebo on some primary/secondary measures, whereas nabiximols 43.2 mg showed significant effects on most measures. PMID 21671456 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dronabinol Other / unclassified 20 mg —
Comparator Dronabinol Other / unclassified 40 mg —
Subject Nabiximols Other / unclassified 10.8 mg Other
Subject Nabiximols Other / unclassified 21.6 mg Other
Subject Nabiximols Other / unclassified 43.2 mg Other

Indications

No indication recorded.