Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT01323569
Brief 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).
Study:
NCT01323569
Study Brief:
Protocol Section:
NCT01323569