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Abuse Potential of Sativex

NCT01323569 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-04-10

No results posted yet for this study

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.

Conditions

  • Evaluation of Abuse Potential of Sativex

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01323569 on ClinicalTrials.gov