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

NCT ID: NCT01438749

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type ACTIVE_COMPARATOR

diazepam

Intervention Type DRUG

Single dose

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single dose

C

Group Type EXPERIMENTAL

RO4917838

Intervention Type DRUG

Single doses (3 dose levels)

Interventions

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Placebo

Single dose

Intervention Type DRUG

RO4917838

Single doses (3 dose levels)

Intervention Type DRUG

diazepam

Single dose

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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BP25259

Identifier Type: -

Identifier Source: org_study_id