A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO4917838; Drug: diazepam; Drug: Placebo

• Registration Number: NCT01438749
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of at least 10 days between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the main study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels), diazepam and placebo in a double-blind, double-dummy inpatient crossover design. Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Study Start: 2011-10
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• Healthy male or female volunteers, 18 to 55 years of age inclusive
• Recreational drug abuse experience (>/= 10 times lifetime abuse of a CNS depressant, >/= 1 abuse of CNS depressant in the previous 3 months
• Body mass index (BMI) 18 to 30 kg/m2 inclusive
• Main study (Part 2): Able to differentiate between diazepam and placebo

Exclusion Criteria

• History of any significant disease or disorder
• History or current diagnosis of substance dependence (excluding caffeine and nicotine)
• Currently seeking or history of participating in treatment for substance-related disorders, including successful completion of such treatment
• Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
• Positive for hepatitis B, hepatitis C or HIV infection
• Pregnant or lactating women
• Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
• Confirmed positive drug screening at screening / any Day -1 (allowed positive THC at screening and any Day -1 and positive benzodiazepine at screening only)
• Positive alcohol breath test at screening / any Day -1
• Heavy smoker (> 20 cigarettes, > 8 pipefuls or > 8 cigars per day)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C	RO4917838	-
A	diazepam	-
B	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics: Abuse potential measured by Visual analogue scales (VAS)	approximately 11 months

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics: Addiction Research Center Inventory (ARCI) subscales	approximately 11 months
Safety: Incidence of adverse events	approximately 11 months
Pharmacokinetics: plasma concentrations of RO4917838	approximately 11 months